Influenza, HumanPhase 1NCT03275389

A Study to Evaluate the Reactogenicity, Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Investigational Supra-seasonal Universal Influenza Vaccines - Inactivated (SUIVs) (GSK3816302A) in Healthy Adults Aged 18 to 39 Years

A Phase 1 study testing D-SUIV cH8/1N1+AS03, D-SUIV cH5/1N1+AS03 and D-SUIV cH11/1N1+AS03 in people with Influenza, Human, run by GlaxoSmithKline at 6 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to assess the reactogenicity, safety and immunogenicity of different formulations of GlaxoSmithKline (GSK) Biologicals' investigational supra-seasonal universal influenza vaccines (SUIVs) (unadjuvanted or adjuvanted) in 18 to 39 year-old healthy subjects. Read more about this study

Who is it for?: Ages 18 to 39 yearsHealthy volunteers can take part
Conditions the study is for: Influenza, Human
What is being tested?: D-SUIV cH8/1N1+AS03, D-SUIV cH5/1N1+AS03 and D-SUIV cH11/1N1+AS03
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 470 participants
Where: 6 sitesin 2 countries
Study dates: 8 Sep 2017to 26 Mar 2020
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 39 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
Written informed consent obtained from the subject prior to performance of any study specific procedure.
A male or female between, and including, 18 and 39 years of age at the time of the first vaccination.
Healthy subjects without acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as established by medical history and clinical examination before first vaccination and laboratory screening tests (the latter being only applicable for subjects enrolled in Phase I).
Subjects with no history of influenza vaccination within 6 months prior to first study vaccination and who are willing to forego any influenza vaccination during the entire study period.
Female subjects of childbearing potential may be enrolled in the study, if the subject:

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Has practiced adequate contraception for 30 days prior to first vaccination, and
Has a negative pregnancy test on the day of vaccination, and
Has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series (last vaccination at Month 14).

Who cannot join

Use of any investigational or non-registered product other than the study vaccines during the period starting 30 days before the first dose of study vaccines, or planned use during the study period.
Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting 6 months prior to the first vaccine dose. For corticosteroids, this will mean prednisone ≥ 20 mg/day, or equivalent. Inhaled and topical steroids are allowed.
Administration of long-acting immune-modifying drugs within 6 months before first vaccination, or planned administration any time during the study period.
Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose up to the blood sampling at Day 85 and in the period starting 30 days before booster vaccination at Month 14 up to the blood sample at Month 14 + 28 days.
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.

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Previous vaccination against influenza within the 6 months preceding the first vaccination at Visit 1 or planned use of such vaccines during the study period.
History of vaccination with a (pre)pandemic influenza vaccine other than an H1N1pdm09 vaccine or history of laboratory-confirmed influenza infection other than seasonal or H1N1pdm09 influenza.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
History of or current autoimmune disease.
Subjects diagnosed with excessive daytime sleepiness or narcolepsy; or history of narcolepsy in a subject's parent or sibling.
History of Guillain-Barré syndrome.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
Hypersensitivity to latex.
Acute disease and/or fever at the time of enrolment.
Fever is defined as temperature ≥ 38.0°C / 100.4°F. The preferred location for measuring temperature in this study will be the oral cavity.
Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
For subjects with acute disease and/or fever at the time of enrolment, Visit 1 may be re-scheduled within the allowed time-window.
Administration of immunoglobulins and/or any blood products during the period starting 3 months before the first dose of study vaccines or planned administration during the study period.
Blood donation within 30 days before the first study blood sampling or planned blood donation within 30 days before and up to 30 days after any study blood sampling.
Pregnant or lactating female.
History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
Female planning to become pregnant or planning to discontinue contraceptive precautions.
Additional criterion applicable for Phase I subjects:
Hematological and/or biochemical parameters outside the laboratory normal ranges, unless the laboratory abnormalities are considered not clinically significant by the investigator.
Liver enzymes (alanine aminotransferase [ALT] or aspartate aminotransferase [AST]) outside of the normal laboratory ranges.

Trial locations and contacts

6 sites in 2 countries.

Country

City, postcode or hospital

6 sites in 2 countries

United States5 sites

GSK Investigational Site
Austin, Texas, 78705
GSK Investigational Site
Norfolk, Virginia, 23502
GSK Investigational Site
Rochester, New York, 14609
GSK Investigational Site
South Miami, Florida, 33143
GSK Investigational Site
Wichita, Kansas, 67207

Other trials in United States

Belgium1 site

GSK Investigational Site
Wilrijk, 2610

Other trials in Belgium

About this study

Official title: Reactogenicity, Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' Investigational Supra-seasonal Universal Influenza Vaccines - Inactivated (SUIVs) (GSK3816302A) in Healthy Adults

Read the detailed description

Current seasonal influenza vaccines show good efficacy when they are well-matched with the circulating virus strains.

However, influenza viruses constantly change their surface glycoproteins that are the targets of most immune responses, allowing them to escape pre-existing immunity, a process called antigenic drift. Therefore, seasonal influenza vaccines have to be reformulated and re-administered on an annual basis. In addition, novel viruses can appear at irregular intervals and cause influenza virus pandemics that can claim millions of lives.

GSK Biologicals is now developing a new influenza vaccine that contains modified inactivated influenza viruses. The purpose of this approach is to elicit an immune response that would protect against all current and future circulating influenza strains without having to administer the vaccine each year.

Conditions: Influenza, Human
Being tested: D-SUIV cH8/1N1+AS03, D-SUIV cH5/1N1+AS03, D-SUIV cH11/1N1+AS03, D-SUIV cH8/1N1+AS01, D-SUIV cH5/1N1+AS01
Keywords: Safety, Healthy adults, Immunogenicity, Supra-seasonal universal influenza vaccines - inactivated (SUIVs)
Medical subject headings: Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

D-SUIV cH8/1N1+AS03Biological
1 Primary dose or 1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH8/1N1 with Adjuvant System 03 (AS03) was administered intramuscularly (IM) in the deltoid region of non-dominant arm.
D-SUIV cH5/1N1+AS03Biological
1 Primary dose or 1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH5/1N1 with Adjuvant System 03 (AS03) was administered IM in the deltoid region of non-dominant arm.
D-SUIV cH11/1N1+AS03Biological
1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH11/1N1 with Adjuvant System 03 (AS03) was administered IM in the deltoid region of non-dominant arm.
D-SUIV cH8/1N1+AS01Biological
1 Primary dose or 1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH8/1N1 with Adjuvant System 01 (AS01) was administered IM in the deltoid region of non-dominant arm.
D-SUIV cH5/1N1+AS01Biological
1 Primary dose or 1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH5/1N1 with Adjuvant System 01 (AS01) was administered IM in the deltoid region of non-dominant arm.
D-SUIV cH11/1N1+AS01Biological
1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH11/1N1 with Adjuvant System 01 (AS01) was administered IM in the deltoid region of non-dominant arm.
D-SUIV cH8/1N1Biological
1 Primary dose or 1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH8/1N1 without adjuvant was administered IM in the deltoid region of non-dominant arm.
D-SUIV cH5/1N1Biological
1 Primary dose or 1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH5/1N1 without adjuvant was administered IM in the deltoid region of non-dominant arm.
D-SUIV cH11/1N1Biological
1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH11/1N1 without adjuvant was administered IM in the deltoid region of non-dominant arm.
PlaceboBiological
1 dose of Phosphate Buffered Saline (PBS) was administered IM in the deltoid region of non-dominant arm.
Fluarix QuadrivalentBiological
1 Primary dose and 1 Booster dose was administered IM in the deltoid region of non-dominant arm.

Study groups in NCT03275389
Study group	Role	What they receive
D-SUIV Adjuvanted Group 1	Experimental	Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm. Receives: Biological: D-SUIV cH8/1N1+AS03; Biological: D-SUIV cH5/1N1+AS03; Biological: Placebo
D-SUIV Adjuvanted Group 2	Experimental	Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm. Receives: Biological: D-SUIV cH8/1N1+AS03; Biological: D-SUIV cH5/1N1+AS03; Biological: Placebo
D-SUIV Adjuvanted Group 3	Experimental	Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm. Receives: Biological: D-SUIV cH8/1N1+AS03; Biological: D-SUIV cH5/1N1+AS03; Biological: D-SUIV cH11/1N1+AS03
D-SUIV Adjuvanted Group 4	Experimental	Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm. Receives: Biological: D-SUIV cH8/1N1+AS01; Biological: D-SUIV cH5/1N1+AS01; Biological: Placebo
D-SUIV Adjuvanted Group 5	Experimental	Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm. Receives: Biological: D-SUIV cH8/1N1+AS01; Biological: D-SUIV cH5/1N1+AS01; Biological: Placebo
D-SUIV Adjuvanted Group 6	Experimental	Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm. Receives: Biological: D-SUIV cH8/1N1+AS01; Biological: D-SUIV cH5/1N1+AS01; Biological: D-SUIV cH11/1N1+AS01
D-SUIV Unadjuvanted Group 1	Experimental	Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm. Receives: Biological: D-SUIV cH8/1N1; Biological: D-SUIV cH5/1N1; Biological: Placebo
D-SUIV Unadjuvanted Group 2	Experimental	Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm. Receives: Biological: D-SUIV cH8/1N1; Biological: D-SUIV cH5/1N1; Biological: Placebo
D-SUIV Unadjuvanted Group 3	Experimental	Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm. Receives: Biological: D-SUIV cH8/1N1; Biological: D-SUIV cH5/1N1; Biological: D-SUIV cH11/1N1
IIV4 Group	Active comparator	Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm. Receives: Biological: Placebo; Biological: Fluarix Quadrivalent

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Subjects With Solicited Local Adverse Events (AEs) After First Dose Administration
Assessed solicited local symptoms are pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Any erythema/swelling = erythema/swelling spreading beyond 20 millimeters (mm) of injection site.
Measured: During the 7-day (Days 1-7) follow-up period after first vaccine dose
Number of Subjects With Solicited Local AEs After Second Dose Administration
Assessed solicited local symptoms are pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Any erythema/swelling = erythema/swelling spreading beyond 20 millimeters (mm) of injection site.
Measured: During the 7-day (Days 1-7) follow-up period after second vaccine dose
Number of Subjects With Solicited Local AEs After Booster Dose Administration
Assessed solicited local symptoms are pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Any erythema/swelling = erythema/swelling spreading beyond 20 mm of injection site.
Measured: During the 7-day (Days 1-7) follow-up period after booster vaccine dose
Number of Subjects With Solicited General AEs After First Dose Administration
Assessed solicited general symptoms are arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever [defined as oral temperature equal to or above 38.0 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade
Measured: During the 7-day (Days 1-7) follow-up period after first vaccine dose
Number of Subjects With Solicited General AEs After Second Dose Administration
Assessed solicited general symptoms are arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever [defined as oral temperature equal to or above 38.0 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade
Measured: During the 7-day (Days 1-7) follow-up period after second vaccine dose
Number of Subjects With Solicited General AEs After Booster Dose Administration
Assessed solicited general symptoms are arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever [defined as oral temperature equal to or above 38.0 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.
Measured: During the 7-day (Days 1-7) follow-up period after booster vaccine dose
Number of Subjects With Any Unsolicited AEs Post-vaccination Period
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination
Measured: During the 28-day (Days 1-28) follow-up period accross doses
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
Hematological parameters assessed are: Eosinophils increase [EOSi], hemoglobin decrease [HEMd] , lymphocytes decrease [LYMd], Neutrophils decrease [NEUd], platelets decrease [PLTCd], white blood cells decrease [WBCd], WBC increase [WBCi]. Biochemical parameters assessed are: alanine aminotransferase increase [ALTi], aspartate aminotransferase increase [ASTi], blood urea nitrogen [BUN], creatinine [CRE].Toxicity grading is according to the Food and Drug Administration (FDA) guidance for industry: Toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical Trials (September 2007). The grading scale is defined as follows: mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4). Category naming has been defined as follows: Parameter- grading at Baseline- grading at Timing: e.g.: "ALT-Grade 0-Grade 1".
Measured: At Day 8
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
Hematological parameters assessed are: EOSi, HEMd, LYMd, NEUd, PLTCd, WBCd, WBCi. Biochemical parameters assessed are: ALTi, ASTi, BUN, CRE. Toxicity grading is according to the FDA guidance for industry: Toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical Trials (September 2007). The grading scale is defined as following: mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4). Category naming has been defined as: Parameter-grading at Baseline-grading at Timing: e.g.: "ALT-Grade 0-Grade 1". The reported results consider any change that occurred during the defined time frame: i.e. any abnormality occurring at an intermediate visit leading to a maximum change from baseline, during the period covered, is the reported result for the outcome.
Measured: From Day 8 to Day 29
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
Hematological parameters assessed are: EOSi, HEMd, LYMd, NEUd, PLTCd, WBCd, WBCi. Biochemical parameters assessed are: ALTi, ASTi, BUN, CRE. Toxicity grading is according to the FDA guidance for industry: Toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical Trials (September 2007). The grading scale is defined as following: mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4). Category naming has been defined as: Parameter-grading at Baseline-grading at Timing: e.g.: "ALT-Grade 0-Grade 1". The reported results consider any change that occurred during the defined time frame: i.e. any abnormality occurring at an intermediate visit leading to a maximum change from baseline, during the period covered, is the reported result for the outcome.
Measured: From Day 8 to Day 85
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
Hematological parameters assessed are: EOSi, HEMd, LYMd, NEUd, PLTCd, WBCd, WBCi. Biochemical parameters assessed are: ALTi, ASTi, BUN, CRE. Toxicity grading is according to the FDA guidance for industry: Toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical Trials (September 2007). The grading scale is defined as following: mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4). Category naming has been defined as: Parameter-grading at Baseline-grading at Timing: e.g.: "ALT-Grade 0-Grade 1". The reported results consider any change that occurred during the defined time frame: i.e. any abnormality occurring at an intermediate visit leading to a maximum change from baseline, during the period covered, is the reported result for the outcome.
Measured: From Day 8 to Month 14 + 28 days
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
Hematological parameters assessed are: EOSi, HEMd, LYMd, NEUd, PLTCd, WBCd, WBCi. Biochemical parameters assessed are: ALTi, ASTi, BUN, CRE. Toxicity grading is according to the FDA guidance for industry: Toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical Trials (September 2007). The grading scale is defined as following: mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4). Category naming has been defined as: Parameter-grading at Baseline-grading at Timing: e.g.: "ALT-Grade 0-Grade 1". The reported results consider any change that occurred during the defined time frame: i.e. any abnormality occurring at an intermediate visit leading to a maximum change from baseline, during the period covered, is the reported result for the outcome.
Measured: From Day 8 to Month 26
Number of Subjects With Any Medically-attended Adverse Events (MAEs)
MAEs are defined as events for which the subject receives medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
Measured: During the entire study period (from Day 1 up to Month 26)
Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs)
pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
Measured: During the entire study period (from Day 1 up to Month 26)
Number of Subjects With Serious Adverse Events (SAEs).
SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Measured: During the entire study period (from Day 1 up to Month 26)
Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)- Day 1
Anti-H1 stalk immune response measured by ELISA. A seropositive subject is a subject whose concentration is greater than or equal to the cut-off value: ELISA cut-off = 66 ELISA.Unit per milliliter (EL.U/mL).
Measured: At Day 1
Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by ELISA- Day 29
Anti-H1 stalk immune response measured by ELISA. A seropositive subject is a subject whose concentration is greater than or equal to the cut-off value: ELISA cut-off = 66 EL.U/mL.
Measured: At Day 29
Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by ELISA- Day 85
Anti-H1 stalk immune response measured by ELISA. A seropositive subject is a subject whose concentration is greater than or equal to the cut-off value: ELISA cut-off = 66 EL.U/mL.
Measured: At Day 85
Concentrations of Serum H1 Stalk Antibodies Measured by ELISA- Day 1
Concentrations are presented as Geometric Mean Concentrations (GMCs) and measured by ELISA. ELISA cut-off = 66 EL.U/mL.
Measured: At Day 1
Concentrations of Serum H1 Stalk Antibodies Measured by ELISA- Day 29
Concentrations are presented as GMCs and measured by ELISA. ELISA cut-off = 66 EL.U/mL.
Measured: At Day 29
Concentrations of Serum H1 Stalk Antibodies Measured by ELISA- Day 85
Concentrations are presented as GMCs and measured by ELISA. ELISA cut-off = 66 EL.U/mL.
Measured: At Day 85
Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by Microneutralization (MN) Assay - Day 1
Anti-H1 stalk immune response measured by MN are expressed in 1/DILUTION (DIL). The functionality of the stalk-reactive antibodies is evaluated by MN assays developed using chimeric viruses. A seropositive subject is a subject whose titer is greater than or equal to the cut-off value: MN cut-off = 20 1/DIL.
Measured: At Day 1
Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by MN Assay - Day 29
Anti-H1 stalk immune response measured by MN are expressed in 1/DIL. The functionality of the stalk-reactive antibodies is evaluated by MN assays developed using chimeric viruses. A seropositive subject is a subject whose titer is greater than or equal to the cut-off value: MN cut-off = 20 1/DIL.
Measured: At Day 29
Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by MN Assay - Day 85
Anti-H1 stalk immune response measured by MN are expressed in 1/DIL. The functionality of the stalk-reactive antibodies is evaluated by MN assays developed using chimeric viruses. A seropositive subject is a subject whose titer is greater than or equal to the cut-off value: MN cut-off = 20 1/DIL.
Measured: At Day 85
Titers for Serum H1 Stalk Antibodies Measured by MN Assay - Day 1
Titers are presented as GMTs and measured by MN assay. MN cut-off = 20 1/DIL.
Measured: At Day 1
Titers for Serum H1 Stalk Antibodies Measured by MN Assay - Day 29
Titers are presented as GMTs and measured by MN assay. MN cut-off = 20 1/DIL.
Measured: At Day 29
Titers for Serum H1 Stalk Antibodies Measured by MN Assay - Day 85
Titers are presented as GMTs and measured by MN assay. MN cut-off = 20 1/DIL.
Measured: At Day 85
Percentage of Subjects With a ≥ 4-fold Increase of Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 29
Percentage of subjects with an equal or greater than (≥) 4-fold increase of anti-H1 stalk antibody concentration, from Day 1, is calculated with exact 95% CI by ELISA.
Measured: At Day 29, compared to pre-vaccination at Day 1
Percentage of Subjects With a ≥ 4-fold Increase of Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 85
Percentage of subjects with a ≥ 4-fold increase of anti-H1 stalk antibody concentration, from Day 1, is calculated with exact 95% CI by ELISA.
Measured: At Day 85, compared to pre-vaccination at Day 1
Percentage of Subjects With a ≥ 4-fold Increase of Anti-H1 Stalk Titer Measured by MN Assay - Day 29
Percentage of subjects with a ≥ 4-fold increase of anti-H1 stalk antibody titer from Day 1, is calculated with exact 95% CI by MN assay.
Measured: At Day 29, compared to pre-vaccination at Day 1
Percentage of Subjects With a ≥ 4-fold Increase of Anti-H1 Stalk Titer Measured by MN Assay - Day 85
Percentage of subjects with a ≥ 4-fold increase of anti-H1 stalk antibody titer from Day 1, is calculated with exact 95% CI by MN assay.
Measured: At Day 85, compared to pre-vaccination at Day 1
Percentage of Subjects With a ≥ 10-fold Increase of Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 29
Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk antibody concentration, from Day 1, is calculated with exact 95% CI by ELISA.
Measured: At Day 29, compared to pre-vaccination at Day 1
Percentage of Subjects With a ≥ 10-fold Increase of Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 85
Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk antibody concentration, from Day 1, is calculated with exact 95% CI by ELISA.
Measured: At Day 85, compared to pre-vaccination at Day 1
Percentage of Subjects With a ≥ 10-fold Increase of Anti-H1 Stalk Titer Measured by MN Assay - Day 29
Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk antibody titer from Day 1, is calculated with exact 95% CI by MN assay.
Measured: At Day 29, compared to pre-vaccination at Day 1
Percentage of Subjects With a ≥ 10-fold Increase of Anti-H1 Stalk Titer Measured by MN Assay - Day 85
Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk antibody titer from Day 1, is calculated with exact 95% CI by MN assay.
Measured: At Day 85, compared to pre-vaccination at Day 1
Mean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 29
MGI is defined as the geometric mean of the fold increase in serum HI concentration post-vaccination compared to Day 1
Measured: At Day 29, compared to pre-vaccination at Day 1
MGI for Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 85
MGI is defined as the geometric mean of the fold increase in serum HI concentration post-vaccination compared to Day 1
Measured: At Day 85, compared to pre-vaccination at Day 1
MGI for Anti-H1 Stalk Antibody Titer Measured by MN Assay - Day 29
MGI is defined as the geometric mean of the fold increase in serum HI titer post-vaccination compared to Day 1
Measured: At Day 29, compared to pre-vaccination at Day 1
MGI for Anti-H1 Stalk Antibody Titer Measured by MN Assay - Day 85
MGI is defined as the geometric mean of the fold increase in serum HI titer post-vaccination compared to Day 1
Measured: At Day 85, compared to pre-vaccination at Day 1

Secondary outcomes (16)

Adjusted GMCs for Anti-H1 HA Stalk Antibody Measured by ELISA
The adjusted GMCs are presented to evaluate the adjuvant effect post-dose 1 and post-dose 2.
Measured: 28 days post priming dose(s) i.e. at Day 29 for 1 priming dose groups and at Day 85 for 2 priming doses groups
Concentrations of Serum H1 Stalk Antibodies Measured by ELISA- Month 8 to 26
Concentrations are presented as GMCs and measured by ELISA. ELISA cut-off = 66 EL.U/mL.
Measured: At Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26.
Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by ELISA- Month 8 to 26
Anti-H1 stalk immune response measured by ELISA. A seropositive subject is a subject whose concentration is greater than or equal to the cut-off value: ELISA cut-off = 66 EL.U/mL.
Measured: At Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26.
Percentage of Subjects With a ≥ 4-fold Increase of Anti-H1 Stalk Antibody Concentration, Measured by ELISA - Month 8 to 26.
Percentage of subjects with a ≥ 4-fold increase of anti-H1 stalk antibody concentration, from Day 1, is calculated with exact 95% CI by ELISA.
Measured: At Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26, compared to Day 1
Percentage of Subjects With a ≥ 10-fold Increase of Anti-H1 Stalk Antibody Concentration, Measured by ELISA - Month 8 to 26.
Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk antibody concentration, from Day 1, is calculated with exact 95% CI by ELISA.
Measured: At Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26, compared to Day 1
MGI for Anti-H1 Stalk Antibody Measured by ELISA - Month 8 to 26
MGI is defined as the geometric mean of the fold increase in serum HI concentration post-vaccination compared to Day 1
Measured: At Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26, compared to Day 1
Concentrations of Anti-H2 and Anti-H18 Antibodies Measured by ELISA
Concentrations are presented as GMCs and measured by ELISA. ELISA cut-off = 22 EL.U/mL (H2) and 43 EL.U/mL (H18).
Measured: At Days 1, 29, 85, Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26
Number of Seropositive Subjects for Anti-H2 and Anti-H18 Antibodies Measured by ELISA
Anti-H2 and anti-H18 immune response measured by ELISA. A seropositive subject is a subject whose concentration is greater than or equal to the cut-off value: ELISA cut-off = 22 EL.U/mL (H2) and 43 EL.U/mL (H18).
Measured: At Days 1, 29, 85, Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26
Percentage of Subjects With a ≥ 4-fold Increase of Anti-H2 and Anti-H18 Antibody Concentration Measured by ELISA
Percentage of subjects with a ≥ 4-fold increase of anti-H2 and anti-H18 antibody concentration, from Day 1, is calculated with exact 95% CI by ELISA .
Measured: At Day 29, at Day 85, Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26, compared to Day 1
Percentage of Subjects With a ≥ 10-fold Increase of Anti-H2 and Anti-H18 Antibody Concentration Measured by ELISA
Percentage of subjects with a ≥ 10-fold increase of anti-H2 and anti-H18 antibody concentration, from Day 1, is calculated with exact 95% CI by ELISA .
Measured: At Day 29, at Day 85, Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26, compared to Day 1
MGI for Anti-H2 and Anti-H18 Antibodies Concentrations Measured by ELISA
MGI is defined as the geometric mean of the fold increase in serum HI concentration post-vaccination compared to Day 1.
Measured: At Day 29, at Day 85, Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26, compared to Day 1
Titers for Anti-H1N1 Swine Influenza and Anti-IIV4-H1N1 Anti-bodies Measured by MN Assay
Titers are presented as GMTs and measured by MN assay. MN cut-off = 20 1/DIL
Measured: At Days 1, 29 and 85
Number of Seropositive Subjects for Anti-H1N1 Swine Influenza and Anti-IIV4-H1N1 Antibodies Measured by MN Assay
Anti-H1N1 swine influenza and anti-IIV4-H1N1 immune response measured by MN assay. A seropositive subject is a subject whose titer is greater than or equal to the cut-off value: cut-off = 20 1/DIL.
Measured: At Days 1, 29 and 85
Percentage of Subjects With a ≥ 4-fold Increase of Anti-H1N1 Swine Influenza and Anti-IIV4-H1N1 Antibody Titers Measured by MN Assay
Percentage of subjects with a ≥ 4-fold increase of anti-H1N1 swine influenza and anti-IIV4-H1N1 antibody titers, from Day 1, is calculated with exact 95% CI by MN assay.
Measured: At Day 29 and Day 85, compared to Day 1
Percentage of Subjects With a ≥ 10-fold Increase of Anti-H1N1 Swine Influenza and Anti-IIV4-H1N1 Antibody Titers Measured by MN Assay
Percentage of subjects with a ≥ 10-fold increase of anti-H1N1 swine influenza and anti-IIV4-H1N1 antibody titers, from Day 1, is calculated with exact 95% CI by MN assay.
Measured: At Day 29 and Day 85, compared to Day 1
MGI for Anti-H1N1 Swine Influenza and Anti-IIV4-H1N1 Antibodies Titers Measured by MN Assay
MGI is defined as the geometric mean of the fold increase in serum HI titer post-vaccination compared to Day 1.
Measured: At Day 29 and at Day 85, compared to Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Sep 201726 Mar 2020

First posted7 Sep 2017
Study start8 Sep 2017
Primary completion26 Mar 2020
Study completion26 Mar 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Influenza, HumanStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 470 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03275389
Sponsor's protocol ID: 207543
Other IDs: 2017-001584-20, 2017
Status last verified: Apr 2021
First submitted: 29 Aug 2017
Last updated: 7 May 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Publications

Folschweiller N, Vanden Abeele C, Chu L, Van Damme P, Garcia-Sastre A, Krammer F, Nachbagauer R, Palese P, Solorzano A, Bi D, David MP, Friel D, Innis BL, Koch J, Mallett CP, Rouxel RN, Salaun B, Vantomme V, Verheust C, Struyf F. Reactogenicity, safety, and immunogenicity of chimeric haemagglutinin influenza split-virion vaccines, adjuvanted with AS01 or AS03 or non-adjuvanted: a phase 1-2 randomised controlled trial. Lancet Infect Dis. 2022 Jul;22(7):1062-1075. doi: 10.1016/S1473-3099(22)00024-X. Epub 2022 Apr 21.
PubMed 35461522

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
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Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Influenza, Human trials

Study at a glance

From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Reactogenicity, Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' Investigational Supra-seasonal Universal Influenza Vaccines - Inactivated (SUIVs) (GSK3816302A) in Healthy Adults
ClinicalTrials.gov ID: NCT03275389
Acronym / sponsor ID: 207543
Conditions: Influenza, Human
Keywords: Safety, Healthy adults, Immunogenicity, Supra-seasonal universal influenza vaccines - inactivated (SUIVs)
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 470 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 8 Sep 2017 (actual)
Primary completion: 26 Mar 2020 (actual)
Study completion: 26 Mar 2020 (actual)
First posted: 7 Sep 2017 (actual)
Results: Posted 7 May 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Current seasonal influenza vaccines show good efficacy when they are well-matched with the circulating virus strains.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 10

Arm	Type	Receives
D-SUIV Adjuvanted Group 1	Experimental	Biological: D-SUIV cH8/1N1+AS03, Biological: D-SUIV cH5/1N1+AS03, Biological: PlaceboSubjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
D-SUIV Adjuvanted Group 2	Experimental	Biological: D-SUIV cH8/1N1+AS03, Biological: D-SUIV cH5/1N1+AS03, Biological: PlaceboSubjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
D-SUIV Adjuvanted Group 3	Experimental	Biological: D-SUIV cH8/1N1+AS03, Biological: D-SUIV cH5/1N1+AS03, Biological: D-SUIV cH11/1N1+AS03Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
D-SUIV Adjuvanted Group 4	Experimental	Biological: D-SUIV cH8/1N1+AS01, Biological: D-SUIV cH5/1N1+AS01, Biological: PlaceboSubjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
D-SUIV Adjuvanted Group 5	Experimental	Biological: D-SUIV cH8/1N1+AS01, Biological: D-SUIV cH5/1N1+AS01, Biological: PlaceboSubjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
D-SUIV Adjuvanted Group 6	Experimental	Biological: D-SUIV cH8/1N1+AS01, Biological: D-SUIV cH5/1N1+AS01, Biological: D-SUIV cH11/1N1+AS01Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
D-SUIV Unadjuvanted Group 1	Experimental	Biological: D-SUIV cH8/1N1, Biological: D-SUIV cH5/1N1, Biological: PlaceboSubjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
D-SUIV Unadjuvanted Group 2	Experimental	Biological: D-SUIV cH8/1N1, Biological: D-SUIV cH5/1N1, Biological: PlaceboSubjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
D-SUIV Unadjuvanted Group 3	Experimental	Biological: D-SUIV cH8/1N1, Biological: D-SUIV cH5/1N1, Biological: D-SUIV cH11/1N1Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
IIV4 Group	Active comparator	Biological: Placebo, Biological: Fluarix QuadrivalentSubjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.

Who may qualify

Ages: 18 to 39 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
Written informed consent obtained from the subject prior to performance of any study specific procedure.
A male or female between, and including, 18 and 39 years of age at the time of the first vaccination.
Healthy subjects without acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as established by medical history and clinical examination before first vaccination and laboratory screening tests (the latter being only applicable for subjects enrolled in Phase I).
Subjects with no history of influenza vaccination within 6 months prior to first study vaccination and who are willing to forego any influenza vaccination during the entire study period.

Key exclusion criteria (26 listed)

Use of any investigational or non-registered product other than the study vaccines during the period starting 30 days before the first dose of study vaccines, or planned use during the study period.
Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting 6 months prior to the first vaccine dose. For corticosteroids, this will mean prednisone ≥ 20 mg/day, or equivalent. Inhaled and topical steroids are allowed.
Administration of long-acting immune-modifying drugs within 6 months before first vaccination, or planned administration any time during the study period.
Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose up to the blood sampling at Day 85 and in the period starting 30 days before booster vaccination at Month 14 up to the blood sample at Month 14 + 28 days.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
D-SUIV cH8/1N1+AS031 Primary dose or 1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH8/1N1 with Adjuvant System 03 (AS03) was administered intramuscularly (IM) in the deltoid region of non-dominant arm.	Biological	D-SUIV Adjuvanted Group 1, D-SUIV Adjuvanted Group 2, D-SUIV Adjuvanted Group 3
D-SUIV cH5/1N1+AS031 Primary dose or 1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH5/1N1 with Adjuvant System 03 (AS03) was administered IM in the deltoid region of non-dominant arm.	Biological	D-SUIV Adjuvanted Group 1, D-SUIV Adjuvanted Group 2, D-SUIV Adjuvanted Group 3
D-SUIV cH11/1N1+AS031 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH11/1N1 with Adjuvant System 03 (AS03) was administered IM in the deltoid region of non-dominant arm.	Biological	D-SUIV Adjuvanted Group 3
D-SUIV cH8/1N1+AS011 Primary dose or 1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH8/1N1 with Adjuvant System 01 (AS01) was administered IM in the deltoid region of non-dominant arm.	Biological	D-SUIV Adjuvanted Group 4, D-SUIV Adjuvanted Group 5, D-SUIV Adjuvanted Group 6
D-SUIV cH5/1N1+AS011 Primary dose or 1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH5/1N1 with Adjuvant System 01 (AS01) was administered IM in the deltoid region of non-dominant arm.	Biological	D-SUIV Adjuvanted Group 4, D-SUIV Adjuvanted Group 5, D-SUIV Adjuvanted Group 6
D-SUIV cH11/1N1+AS011 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH11/1N1 with Adjuvant System 01 (AS01) was administered IM in the deltoid region of non-dominant arm.	Biological	D-SUIV Adjuvanted Group 6
D-SUIV cH8/1N11 Primary dose or 1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH8/1N1 without adjuvant was administered IM in the deltoid region of non-dominant arm.	Biological	D-SUIV Unadjuvanted Group 1, D-SUIV Unadjuvanted Group 2, D-SUIV Unadjuvanted Group 3
D-SUIV cH5/1N11 Primary dose or 1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH5/1N1 without adjuvant was administered IM in the deltoid region of non-dominant arm.	Biological	D-SUIV Unadjuvanted Group 1, D-SUIV Unadjuvanted Group 2, D-SUIV Unadjuvanted Group 3
D-SUIV cH11/1N11 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH11/1N1 without adjuvant was administered IM in the deltoid region of non-dominant arm.	Biological	D-SUIV Unadjuvanted Group 3
Placebo1 dose of Phosphate Buffered Saline (PBS) was administered IM in the deltoid region of non-dominant arm.	Biological	D-SUIV Adjuvanted Group 1, D-SUIV Adjuvanted Group 2, D-SUIV Adjuvanted Group 4, D-SUIV Adjuvanted Group 5, D-SUIV Unadjuvanted Group 1, D-SUIV Unadjuvanted Group 2, IIV4 Group
Fluarix Quadrivalent1 Primary dose and 1 Booster dose was administered IM in the deltoid region of non-dominant arm.	Biological	IIV4 Group

Primary outcome

Number of Subjects With Solicited Local Adverse Events (AEs) After First Dose Administration
Time frame: During the 7-day (Days 1-7) follow-up period after first vaccine dose
Assessed solicited local symptoms are pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Any erythema/swelling = erythema/swelling spreading beyond 20 millimeters (mm) of injection site.
Number of Subjects With Solicited Local AEs After Second Dose Administration
Time frame: During the 7-day (Days 1-7) follow-up period after second vaccine dose
Assessed solicited local symptoms are pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Any erythema/swelling = erythema/swelling spreading beyond 20 millimeters (mm) of injection site.
Number of Subjects With Solicited Local AEs After Booster Dose Administration
Time frame: During the 7-day (Days 1-7) follow-up period after booster vaccine dose
Assessed solicited local symptoms are pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Any erythema/swelling = erythema/swelling spreading beyond 20 mm of injection site.
Number of Subjects With Solicited General AEs After First Dose Administration
Time frame: During the 7-day (Days 1-7) follow-up period after first vaccine dose
Assessed solicited general symptoms are arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever [defined as oral temperature equal to or above 38.0 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade
Number of Subjects With Solicited General AEs After Second Dose Administration
Time frame: During the 7-day (Days 1-7) follow-up period after second vaccine dose
Assessed solicited general symptoms are arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever [defined as oral temperature equal to or above 38.0 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade
Number of Subjects With Solicited General AEs After Booster Dose Administration
Time frame: During the 7-day (Days 1-7) follow-up period after booster vaccine dose
Assessed solicited general symptoms are arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever [defined as oral temperature equal to or above 38.0 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.
Number of Subjects With Any Unsolicited AEs Post-vaccination Period
Time frame: During the 28-day (Days 1-28) follow-up period accross doses
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
Time frame: At Day 8
Hematological parameters assessed are: Eosinophils increase [EOSi], hemoglobin decrease [HEMd] , lymphocytes decrease [LYMd], Neutrophils decrease [NEUd], platelets decrease [PLTCd], white blood cells decrease [WBCd], WBC increase [WBCi]. Biochemical parameters assessed are: alanine aminotransferase increase [ALTi], aspartate aminotransferase increase [ASTi], blood urea nitrogen [BUN], creatinine [CRE].Toxicity grading is according to the Food and Drug Administration (FDA) guidance for industry: Toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical Trials (September 2007). The grading scale is defined as follows: mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4). Category naming has been defined as follows: Parameter- grading at Baseline- grading at Timing: e.g.: "ALT-Grade 0-Grade 1".
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
Time frame: From Day 8 to Day 29
Hematological parameters assessed are: EOSi, HEMd, LYMd, NEUd, PLTCd, WBCd, WBCi. Biochemical parameters assessed are: ALTi, ASTi, BUN, CRE. Toxicity grading is according to the FDA guidance for industry: Toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical Trials (September 2007). The grading scale is defined as following: mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4). Category naming has been defined as: Parameter-grading at Baseline-grading at Timing: e.g.: "ALT-Grade 0-Grade 1". The reported results consider any change that occurred during the defined time frame: i.e. any abnormality occurring at an intermediate visit leading to a maximum change from baseline, during the period covered, is the reported result for the outcome.
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
Time frame: From Day 8 to Day 85
Hematological parameters assessed are: EOSi, HEMd, LYMd, NEUd, PLTCd, WBCd, WBCi. Biochemical parameters assessed are: ALTi, ASTi, BUN, CRE. Toxicity grading is according to the FDA guidance for industry: Toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical Trials (September 2007). The grading scale is defined as following: mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4). Category naming has been defined as: Parameter-grading at Baseline-grading at Timing: e.g.: "ALT-Grade 0-Grade 1". The reported results consider any change that occurred during the defined time frame: i.e. any abnormality occurring at an intermediate visit leading to a maximum change from baseline, during the period covered, is the reported result for the outcome.
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
Time frame: From Day 8 to Month 14 + 28 days
Hematological parameters assessed are: EOSi, HEMd, LYMd, NEUd, PLTCd, WBCd, WBCi. Biochemical parameters assessed are: ALTi, ASTi, BUN, CRE. Toxicity grading is according to the FDA guidance for industry: Toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical Trials (September 2007). The grading scale is defined as following: mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4). Category naming has been defined as: Parameter-grading at Baseline-grading at Timing: e.g.: "ALT-Grade 0-Grade 1". The reported results consider any change that occurred during the defined time frame: i.e. any abnormality occurring at an intermediate visit leading to a maximum change from baseline, during the period covered, is the reported result for the outcome.
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
Time frame: From Day 8 to Month 26
Hematological parameters assessed are: EOSi, HEMd, LYMd, NEUd, PLTCd, WBCd, WBCi. Biochemical parameters assessed are: ALTi, ASTi, BUN, CRE. Toxicity grading is according to the FDA guidance for industry: Toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical Trials (September 2007). The grading scale is defined as following: mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4). Category naming has been defined as: Parameter-grading at Baseline-grading at Timing: e.g.: "ALT-Grade 0-Grade 1". The reported results consider any change that occurred during the defined time frame: i.e. any abnormality occurring at an intermediate visit leading to a maximum change from baseline, during the period covered, is the reported result for the outcome.
Number of Subjects With Any Medically-attended Adverse Events (MAEs)
Time frame: During the entire study period (from Day 1 up to Month 26)
MAEs are defined as events for which the subject receives medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs)
Time frame: During the entire study period (from Day 1 up to Month 26)
pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
Number of Subjects With Serious Adverse Events (SAEs).
Time frame: During the entire study period (from Day 1 up to Month 26)
SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)- Day 1
Time frame: At Day 1
Anti-H1 stalk immune response measured by ELISA. A seropositive subject is a subject whose concentration is greater than or equal to the cut-off value: ELISA cut-off = 66 ELISA.Unit per milliliter (EL.U/mL).
Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by ELISA- Day 29
Time frame: At Day 29
Anti-H1 stalk immune response measured by ELISA. A seropositive subject is a subject whose concentration is greater than or equal to the cut-off value: ELISA cut-off = 66 EL.U/mL.
Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by ELISA- Day 85
Time frame: At Day 85
Anti-H1 stalk immune response measured by ELISA. A seropositive subject is a subject whose concentration is greater than or equal to the cut-off value: ELISA cut-off = 66 EL.U/mL.
Concentrations of Serum H1 Stalk Antibodies Measured by ELISA- Day 1
Time frame: At Day 1
Concentrations are presented as Geometric Mean Concentrations (GMCs) and measured by ELISA. ELISA cut-off = 66 EL.U/mL.
Concentrations of Serum H1 Stalk Antibodies Measured by ELISA- Day 29
Time frame: At Day 29
Concentrations are presented as GMCs and measured by ELISA. ELISA cut-off = 66 EL.U/mL.
Concentrations of Serum H1 Stalk Antibodies Measured by ELISA- Day 85
Time frame: At Day 85
Concentrations are presented as GMCs and measured by ELISA. ELISA cut-off = 66 EL.U/mL.
Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by Microneutralization (MN) Assay - Day 1
Time frame: At Day 1
Anti-H1 stalk immune response measured by MN are expressed in 1/DILUTION (DIL). The functionality of the stalk-reactive antibodies is evaluated by MN assays developed using chimeric viruses. A seropositive subject is a subject whose titer is greater than or equal to the cut-off value: MN cut-off = 20 1/DIL.
Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by MN Assay - Day 29
Time frame: At Day 29
Anti-H1 stalk immune response measured by MN are expressed in 1/DIL. The functionality of the stalk-reactive antibodies is evaluated by MN assays developed using chimeric viruses. A seropositive subject is a subject whose titer is greater than or equal to the cut-off value: MN cut-off = 20 1/DIL.
Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by MN Assay - Day 85
Time frame: At Day 85
Anti-H1 stalk immune response measured by MN are expressed in 1/DIL. The functionality of the stalk-reactive antibodies is evaluated by MN assays developed using chimeric viruses. A seropositive subject is a subject whose titer is greater than or equal to the cut-off value: MN cut-off = 20 1/DIL.
Titers for Serum H1 Stalk Antibodies Measured by MN Assay - Day 1
Time frame: At Day 1
Titers are presented as GMTs and measured by MN assay. MN cut-off = 20 1/DIL.
Titers for Serum H1 Stalk Antibodies Measured by MN Assay - Day 29
Time frame: At Day 29
Titers are presented as GMTs and measured by MN assay. MN cut-off = 20 1/DIL.
Titers for Serum H1 Stalk Antibodies Measured by MN Assay - Day 85
Time frame: At Day 85
Titers are presented as GMTs and measured by MN assay. MN cut-off = 20 1/DIL.
Percentage of Subjects With a ≥ 4-fold Increase of Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 29
Time frame: At Day 29, compared to pre-vaccination at Day 1
Percentage of subjects with an equal or greater than (≥) 4-fold increase of anti-H1 stalk antibody concentration, from Day 1, is calculated with exact 95% CI by ELISA.
Percentage of Subjects With a ≥ 4-fold Increase of Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 85
Time frame: At Day 85, compared to pre-vaccination at Day 1
Percentage of subjects with a ≥ 4-fold increase of anti-H1 stalk antibody concentration, from Day 1, is calculated with exact 95% CI by ELISA.
Percentage of Subjects With a ≥ 4-fold Increase of Anti-H1 Stalk Titer Measured by MN Assay - Day 29
Time frame: At Day 29, compared to pre-vaccination at Day 1
Percentage of subjects with a ≥ 4-fold increase of anti-H1 stalk antibody titer from Day 1, is calculated with exact 95% CI by MN assay.
Percentage of Subjects With a ≥ 4-fold Increase of Anti-H1 Stalk Titer Measured by MN Assay - Day 85
Time frame: At Day 85, compared to pre-vaccination at Day 1
Percentage of subjects with a ≥ 4-fold increase of anti-H1 stalk antibody titer from Day 1, is calculated with exact 95% CI by MN assay.
Percentage of Subjects With a ≥ 10-fold Increase of Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 29
Time frame: At Day 29, compared to pre-vaccination at Day 1
Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk antibody concentration, from Day 1, is calculated with exact 95% CI by ELISA.
Percentage of Subjects With a ≥ 10-fold Increase of Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 85
Time frame: At Day 85, compared to pre-vaccination at Day 1
Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk antibody concentration, from Day 1, is calculated with exact 95% CI by ELISA.
Percentage of Subjects With a ≥ 10-fold Increase of Anti-H1 Stalk Titer Measured by MN Assay - Day 29
Time frame: At Day 29, compared to pre-vaccination at Day 1
Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk antibody titer from Day 1, is calculated with exact 95% CI by MN assay.
Percentage of Subjects With a ≥ 10-fold Increase of Anti-H1 Stalk Titer Measured by MN Assay - Day 85
Time frame: At Day 85, compared to pre-vaccination at Day 1
Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk antibody titer from Day 1, is calculated with exact 95% CI by MN assay.
Mean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 29
Time frame: At Day 29, compared to pre-vaccination at Day 1
MGI is defined as the geometric mean of the fold increase in serum HI concentration post-vaccination compared to Day 1
MGI for Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 85
Time frame: At Day 85, compared to pre-vaccination at Day 1
MGI is defined as the geometric mean of the fold increase in serum HI concentration post-vaccination compared to Day 1
MGI for Anti-H1 Stalk Antibody Titer Measured by MN Assay - Day 29
Time frame: At Day 29, compared to pre-vaccination at Day 1
MGI is defined as the geometric mean of the fold increase in serum HI titer post-vaccination compared to Day 1
MGI for Anti-H1 Stalk Antibody Titer Measured by MN Assay - Day 85
Time frame: At Day 85, compared to pre-vaccination at Day 1
MGI is defined as the geometric mean of the fold increase in serum HI titer post-vaccination compared to Day 1

16 secondary outcomes

Adjusted GMCs for Anti-H1 HA Stalk Antibody Measured by ELISA
Time frame: 28 days post priming dose(s) i.e. at Day 29 for 1 priming dose groups and at Day 85 for 2 priming doses groups
Concentrations of Serum H1 Stalk Antibodies Measured by ELISA- Month 8 to 26
Time frame: At Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26.
Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by ELISA- Month 8 to 26
Time frame: At Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26.
Percentage of Subjects With a ≥ 4-fold Increase of Anti-H1 Stalk Antibody Concentration, Measured by ELISA - Month 8 to 26.
Time frame: At Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26, compared to Day 1
Percentage of Subjects With a ≥ 10-fold Increase of Anti-H1 Stalk Antibody Concentration, Measured by ELISA - Month 8 to 26.
Time frame: At Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26, compared to Day 1
MGI for Anti-H1 Stalk Antibody Measured by ELISA - Month 8 to 26
Time frame: At Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26, compared to Day 1
Concentrations of Anti-H2 and Anti-H18 Antibodies Measured by ELISA
Time frame: At Days 1, 29, 85, Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26
Number of Seropositive Subjects for Anti-H2 and Anti-H18 Antibodies Measured by ELISA
Time frame: At Days 1, 29, 85, Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26
Percentage of Subjects With a ≥ 4-fold Increase of Anti-H2 and Anti-H18 Antibody Concentration Measured by ELISA
Time frame: At Day 29, at Day 85, Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26, compared to Day 1
Percentage of Subjects With a ≥ 10-fold Increase of Anti-H2 and Anti-H18 Antibody Concentration Measured by ELISA
Time frame: At Day 29, at Day 85, Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26, compared to Day 1
MGI for Anti-H2 and Anti-H18 Antibodies Concentrations Measured by ELISA
Time frame: At Day 29, at Day 85, Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26, compared to Day 1
Titers for Anti-H1N1 Swine Influenza and Anti-IIV4-H1N1 Anti-bodies Measured by MN Assay
Time frame: At Days 1, 29 and 85
Number of Seropositive Subjects for Anti-H1N1 Swine Influenza and Anti-IIV4-H1N1 Antibodies Measured by MN Assay
Time frame: At Days 1, 29 and 85
Percentage of Subjects With a ≥ 4-fold Increase of Anti-H1N1 Swine Influenza and Anti-IIV4-H1N1 Antibody Titers Measured by MN Assay
Time frame: At Day 29 and Day 85, compared to Day 1
Percentage of Subjects With a ≥ 10-fold Increase of Anti-H1N1 Swine Influenza and Anti-IIV4-H1N1 Antibody Titers Measured by MN Assay
Time frame: At Day 29 and Day 85, compared to Day 1
MGI for Anti-H1N1 Swine Influenza and Anti-IIV4-H1N1 Antibodies Titers Measured by MN Assay
Time frame: At Day 29 and at Day 85, compared to Day 1

Results and safety

Results posted to the registry on 7 May 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
D-SUIV Adjuvanted Group 1	45	34
D-SUIV Adjuvanted Group 2	46	30
D-SUIV Adjuvanted Group 3	47	24
D-SUIV Adjuvanted Group 4	47	25
D-SUIV Adjuvanted Group 5	48	32
D-SUIV Adjuvanted Group 6	47	29
D-SUIV Unadjuvanted Group 1	47	22
D-SUIV Unadjuvanted Group 2	48	30
D-SUIV Unadjuvanted Group 3	46	31
IIV4 Group	47	29

Primary outcome: Number of Subjects With Solicited Local Adverse Events (AEs) After First Dose Administration

Time frame: During the 7-day (Days 1-7) follow-up period after first vaccine dose. Count of participants. Unit: Participants

Measure	D-SUIV Adjuvanted Group 1 n = 44	D-SUIV Adjuvanted Group 2 n = 46	D-SUIV Adjuvanted Group 3 n = 45	D-SUIV Adjuvanted Group 4 n = 46	D-SUIV Adjuvanted Group 5 n = 46	D-SUIV Adjuvanted Group 6 n = 46	D-SUIV Unadjuvanted Group 1 n = 45	D-SUIV Unadjuvanted Group 2 n = 47	D-SUIV Unadjuvanted Group 3 n = 46	IIV4 Group n = 45
Erythema	1	3	2	2	1	3	1	0	1	0
Pain	34	42	37	39	40	42	16	13	15	35
Swelling	4	2	2	4	3	2	0	0	1	0

Population analysed: Analysis was performed on the Exposed Set (ES) which included all subjects with the vaccine dose documented.

Primary outcome: Number of Subjects With Solicited Local AEs After Second Dose Administration

Time frame: During the 7-day (Days 1-7) follow-up period after second vaccine dose. Count of participants. Unit: Participants

Measure	D-SUIV Adjuvanted Group 1 n = 40	D-SUIV Adjuvanted Group 2 n = 37	D-SUIV Adjuvanted Group 3 n = 36	D-SUIV Adjuvanted Group 4 n = 41	D-SUIV Adjuvanted Group 5 n = 41	D-SUIV Adjuvanted Group 6 n = 37	D-SUIV Unadjuvanted Group 1 n = 38	D-SUIV Unadjuvanted Group 2 n = 39	D-SUIV Unadjuvanted Group 3 n = 40	IIV4 Group n = 39
Erythema	0	0	1	0	0	0	0	0	0	0
Pain	5	2	29	2	8	32	4	5	12	10
Swelling	0	0	4	0	0	2	0	0	0	0

Population analysed: Analysis was performed on the ES which included all subjects with the vaccine dose documented.

Primary outcome: Number of Subjects With Solicited Local AEs After Booster Dose Administration

Time frame: During the 7-day (Days 1-7) follow-up period after booster vaccine dose. Count of participants. Unit: Participants

Measure	D-SUIV Adjuvanted Group 1 n = 33	D-SUIV Adjuvanted Group 2 n = 32	D-SUIV Adjuvanted Group 3 n = 27	D-SUIV Adjuvanted Group 4 n = 30	D-SUIV Adjuvanted Group 5 n = 31	D-SUIV Adjuvanted Group 6 n = 30	D-SUIV Unadjuvanted Group 1 n = 24	D-SUIV Unadjuvanted Group 2 n = 32	D-SUIV Unadjuvanted Group 3 n = 33	IIV4 Group n = 31
Erythema	1	1	0	0	1	1	0	0	0	0
Pain	27	31	26	29	28	25	4	10	13	21
Swelling	2	2	0	1	1	1	0	0	0	0

Population analysed: Analysis was performed on the ES which included all subjects with the vaccine dose documented.

Primary outcome: Number of Subjects With Solicited General AEs After First Dose Administration

Time frame: During the 7-day (Days 1-7) follow-up period after first vaccine dose. Count of participants. Unit: Participants

Measure	D-SUIV Adjuvanted Group 1 n = 44	D-SUIV Adjuvanted Group 2 n = 46	D-SUIV Adjuvanted Group 3 n = 45	D-SUIV Adjuvanted Group 4 n = 46	D-SUIV Adjuvanted Group 5 n = 46	D-SUIV Adjuvanted Group 6 n = 46	D-SUIV Unadjuvanted Group 1 n = 45	D-SUIV Unadjuvanted Group 2 n = 47	D-SUIV Unadjuvanted Group 3 n = 46	IIV4 Group n = 46
Arthralgia	4	6	9	2	3	8	6	5	2	5
Fatigue	17	18	22	18	21	18	17	19	12	12
Gastrointestinal symptoms	6	7	10	6	8	8	6	8	10	8
Headache	18	18	19	23	16	26	16	19	15	14
Myalgia	16	13	19	17	19	20	9	9	6	11
Shivering	6	3	10	10	8	9	2	2	2	3
Temperature	1	1	0	2	2	1	1	1	0	0

Population analysed: Analysis was performed on the ES which included all subjects with the vaccine dose documented.

16 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
D-SUIV Adjuvanted Group 1	2 of 45 (4.4%)	40 of 45 (88.9%)	0 of 45
D-SUIV Adjuvanted Group 2	1 of 46 (2.2%)	43 of 46 (93.5%)	0 of 46
D-SUIV Adjuvanted Group 3	1 of 47 (2.1%)	44 of 47 (93.6%)	0 of 47
D-SUIV Adjuvanted Group 4	2 of 47 (4.3%)	44 of 47 (93.6%)	0 of 47
D-SUIV Adjuvanted Group 5	2 of 48 (4.2%)	45 of 48 (93.8%)	0 of 48
D-SUIV Adjuvanted Group 6	2 of 47 (4.3%)	44 of 47 (93.6%)	1 of 47
D-SUIV Unadjuvanted Group 1	0 of 47 (0%)	34 of 47 (72.3%)	0 of 47
D-SUIV Unadjuvanted Group 2	2 of 48 (4.2%)	38 of 48 (79.2%)	0 of 48
D-SUIV Unadjuvanted Group 3	2 of 46 (4.3%)	42 of 46 (91.3%)	0 of 46
IIV4 Group	3 of 47 (6.4%)	44 of 47 (93.6%)	0 of 47

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35461522Folschweiller N, Vanden Abeele C, Chu L, Van Damme P, Garcia-Sastre A, Krammer F, Nachbagauer R, Palese P, Solorzano A, Bi D, David MP, Friel D, Innis BL, Koch J, Mallett CP, Rouxel RN, Salaun B, Vantomme V, Verheust C, Struyf F. Reactogenicity, safety, and immunogenicity of chimeric haemagglutinin influenza split-virion vaccines, adjuvanted with AS01 or AS03 or non-adjuvanted: a phase 1-2 randomised controlled trial. Lancet Infect Dis. 2022 Jul;22(7):1062-1075. doi: 10.1016/S1473-3099(22)00024-X. Epub 2022 Apr 21.
Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

6 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing D-SUIV cH8/1N1+AS03, D-SUIV cH5/1N1+AS03 and D-SUIV cH11/1N1+AS03 in people with Influenza, Human, run by GlaxoSmithKline at 6 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects With Solicited Local Adverse Events (AEs) After First Dose Administration (time frame: During the 7-day (Days 1-7) follow-up period after first vaccine dose). The study lists 39 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03275389, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2021.