Influenza, HumanPhase 2NCT04789577

A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline Biologicals' Influenza Vaccine GSK3206641A Administered in Adults 18 to 64 Years of Age and 65 Years of Age and Older

A Phase 2 study testing FLU-Q-PAN H7N9 Formulation 1, FLU-Q-PAN H7N9 Formulation 2 and FLU-Q-PAN H7N9 Formulation 3 in people with Influenza, Human, run by GlaxoSmithKline at 8 sites in United States.

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

Study to evaluate the safety and immunogenicity of H7N9 antigen in combination with full or half doses of AS03 adjuvant system in healthy adults. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Influenza, Human
What is being tested?: FLU-Q-PAN H7N9 Formulation 1, FLU-Q-PAN H7N9 Formulation 2 and FLU-Q-PAN H7N9 Formulation 3
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 833 participants
Where: 8 sitesUnited States
Study dates: 16 Mar 2021to 12 Sep 2022
Phase: Phase 2
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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy participants as established by medical history and clinical examination before entering into the study.
A male or female ≥ 18 years of age at the time of first vaccination.
Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards and COVID-19 assessment card, return for follow-up visits, or return the diary cards and COVID-19 assessment card in a timely manner using the pre stamped envelope received at the site).
Written or witnessed/thumb printed informed consent obtained from the participant prior to performance of any study specific procedure.
Female participants of non-childbearing potential may be enrolled in the study. Non childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion hysterectomy, bilateral ovariectomy or post-menopause.
Female participants of childbearing potential may be enrolled in the study, if the participant:

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has practiced adequate contraception for 1 month prior to 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.

Who cannot join

Current diagnosis or history of autoimmune disorder(s).
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
Hypersensitivity to latex.
Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality that appears uncontrolled, as determined by history or physical examination.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
Recurrent history or uncontrolled neurological disorders or seizures.

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History of Guillain-Barré syndrome.
Diagnosed with narcolepsy; or history of narcolepsy in a participant's parent, sibling or child.
Diagnosed with cancer, or treatment for cancer within 3 years.
Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible.
Persons with a history of histologically-confirmed basal cell carcinoma of the skin successfully treated with local excision only are accepted and are eligible, but other histologic types of skin cancer are exclusionary.
Women who are disease-free 3 years or more after treatment for breast cancer and receiving long-term prophylaxis (for example, with tamoxifen) are eligible.
Documented human immunodeficiency virus-positive participant.
Any clinically significant* hematological laboratory abnormality.
The investigator should use his/her clinical judgement to decide which abnormalities are clinically significant.
Bedridden participants.
Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study vaccine/product during the period beginning 30 days before the first dose of study vaccine/product (Day -29 to Day 1), or planned use during the study period.
Administration of long-acting immune-modifying drugs at any time during the study period (e.g. infliximab).
Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the first dose of study vaccine/product or planned administration during the study period.
Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first vaccine/product dose. For corticosteroids, this will mean prednisone equivalent ≥ 20 mg/day. Inhaled and topical steroids are allowed.
Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product (drug or medical device).
Pregnant or lactating female.
Female planning to become pregnant or planning to discontinue contraceptive precautions within 2 months after completion of the vaccination series.
History of or current chronic alcohol consumption and/or drug abuse.
Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
Any study personnel or immediate dependents, family, or household member.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

GSK Investigational Site
Cary, North Carolina, 27518
GSK Investigational Site
Cleveland, Ohio, 44122
GSK Investigational Site
Houston, Texas, 77081
GSK Investigational Site
Meridian, Idaho, 83642
GSK Investigational Site
Mt. Pleasant, South Carolina, 29464
GSK Investigational Site
Stockbridge, Georgia, 30281
GSK Investigational Site
West Jordan, Utah, 84088
GSK Investigational Site
Wilmington, North Carolina, 28401

Other trials in United States

About this study

Official title: A Phase I/II Observer-blind, Randomized, Placebo-controlled, Multi-center Trial to Evaluate the Safety and Immunogenicity of Different Formulations of Monovalent Influenza A/Hong Kong/125/2017-like (H7N9) Virus Vaccine With AS03 Adjuvant System, Given as a Two-dose Series to Adults 18 to 64 Years of Age and 65 Years of Age and Older

Study to evaluate the safety and immunogenicity of H7N9 antigen in combination with full or half doses of AS03 adjuvant system in healthy adults.

Conditions: Influenza, Human
Being tested: FLU-Q-PAN H7N9 Formulation 1, FLU-Q-PAN H7N9 Formulation 2, FLU-Q-PAN H7N9 Formulation 3, AS03B, AS03A
Medical subject headings: Influenza, Human

What participants receive

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

FLU-Q-PAN H7N9 Formulation 1Biological
Participants received two doses of the FLU-Q-PAN H7N9 Formulation 1 vaccine by intramuscular injection in the non-dominant arm.
FLU-Q-PAN H7N9 Formulation 2Biological
Participants received two doses of the FLU-Q-PAN H7N9 Formulation 2 vaccine by intramuscular injection in the non-dominant arm.
FLU-Q-PAN H7N9 Formulation 3Biological
Participants received two doses of the FLU-Q-PAN H7N9 Formulation 3 vaccine by intramuscular injection in the non-dominant arm.
AS03BBiological
Participants received two doses of the AS03B adjuvant by intramuscular injection in the non-dominant arm.
AS03ABiological
Participants received two doses of the AS03A adjuvant by intramuscular injection in the non-dominant arm.
PlaceboDrug
Participants received two doses of Placebo by intramuscular injection in the non-dominant arm.

Study groups in NCT04789577
Study group	Role	What they receive
FLU-Q-PAN H7N9 Formulation 1_B Group	Active comparator	Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22. Receives: Biological: FLU-Q-PAN H7N9 Formulation 1; Biological: AS03B
FLU-Q-PAN H7N9 Formulation 1_A Group	Active comparator	Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22. Receives: Biological: FLU-Q-PAN H7N9 Formulation 1; Biological: AS03A
FLU-Q-PAN H7N9 Formulation 2_B Group	Active comparator	Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22. Receives: Biological: FLU-Q-PAN H7N9 Formulation 2; Biological: AS03B
FLU-Q-PAN H7N9 Formulation 2_A Group	Active comparator	Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22. Receives: Biological: FLU-Q-PAN H7N9 Formulation 2; Biological: AS03A
FLU-Q-PAN H7N9 Formulation 3_B Group	Active comparator	Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22. Receives: Biological: FLU-Q-PAN H7N9 Formulation 3; Biological: AS03B
FLU-Q-PAN H7N9 Formulation 3_A Group	Active comparator	Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22. Receives: Biological: FLU-Q-PAN H7N9 Formulation 3; Biological: AS03A
Placebo Group	Placebo comparator	Healthy male and female participants who received two doses of placebo, the first dose at Day 1 and the second dose at Day 22. Receives: Drug: Placebo

What is being measured

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

Percentage of Seroprotected Participants for Anti-hemagglutination Inhibition (HI) Antibodies Against Vaccine-homologous H7N9
Center for Biologics Evaluation and Research (CBER) criteria for seroprotection rate (SPR) for 18 to 64 years of age is shown if the Lower Limit (LL) of the 99.17% confidence interval (CI) for the SPR meets or exceeds 70%, and for greater than or equal to (≥) 65 years of age if the LL of the 99.17% CI for the SPR meets or exceeds 60%. SPR is defined as the percentage of participants with an HI antibody titer ≥40 1/dilution (DIL). The percentage of participants was calculated along with Clopper-Pearson exact two-sided 99.17% CIs.
Measured: At Day 43
Percentage of Seroconverted Participants for Anti-HI Antibodies Against Vaccine-homologous H7N9
CBER criteria for seroconversion rate (SCR) for 18 to 64 years of age is shown if LL of the 99.17% CI for the SCR meets or exceeds 40%, and for ≥65 years of age, if the LL of the 99.17% CI for the SCR meets or exceeds 30%. Seroconversion is defined as a post-vaccination antibody titer ≥40 1/DIL in the serum of participants seronegative before vaccination (i.e. titer < assay cut-off at Day 1). For seropositive participants (i.e. titer ≥ assay cut-off at Day 1), seroconversion requires a 4-fold rise in post-vaccination HI antibody titer (but at least a titer of 40 1/DIL). The percentage of participants was calculated with Clopper-Pearson exact two-sided 99.17% CIs.
Note: The cut-off value for antibody titer was defined by the laboratory before the analysis.
Measured: At Day 43
Number of Participants With Any Solicited Administration Site Events
Solicited administered site events assessed were pain, redness and swelling. Any Pain = occurrence of symptom regardless of intensity grade. Any Redness or any Swelling symptom = any symptom having a surface diameter greater than (>) 20 millimeters (mm).
Measured: Within the 7-day follow-up period after Dose 1
Number of Participants With Any Solicited Administration Site Events
Solicited administered site events assessed were pain, redness and swelling. Any Pain = occurrence of symptom regardless of intensity grade. Any Redness or any Swelling symptom = any symptom having a surface diameter >20 mm.
Measured: Within the 7-day follow-up period after Dose 2
Number of Participants With Any Solicited Systemic Events
Solicited systemic events assessed were fatigue, fever, headache, muscle ache all over body, joint pain, shivering, sweating and gastrointestinal symptoms (Nausea, vomiting, diarrhea and abdominal pain). Any = occurrence of symptom regardless of intensity grade. Fever was defined as temperature ≥38 degrees Celsius (°C) for oral route (preferred location for measuring temperature).
Measured: Within the 7-day follow-up period after Dose 1
Number of Participants With Any Solicited Systemic Events
Solicited systemic events assessed were fatigue, fever, headache, muscle ache all over body, joint pain, shivering, sweating and gastrointestinal symptoms (Nausea, vomiting, diarrhea and abdominal pain). Any = occurrence of symptom regardless of intensity grade. Fever was defined as temperature ≥38°C for oral route (preferred location for measuring temperature).
Measured: Within the 7-day follow-up period after Dose 2
Number of Participants With Any and Related Unsolicited Adverse Events
An unsolicited adverse event (AE) is an AE that was not solicited using a Participant Diary and that was spontaneously communicated by a participant who had signed the informed consent. Unsolicited AEs include serious and non-serious AEs. Potential unsolicited AEs may have been medically attended (i.e. symptoms or illnesses requiring a hospitalization, or emergency room visit, or visit to/by a health care provider). Unsolicited AEs that were not medically attended nor perceived as a concern by participant were collected during interview with the participants and by review of available medical records at the following visit. An unsolicited adverse event is any event 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.
Measured: Within the 21-day follow-up period after Dose 1
Number of Participants With Any and Related Unsolicited Adverse Events
An unsolicited AE is an AE that was not solicited using a Participant Diary and that was spontaneously communicated by a participant who has signed the informed consent. Unsolicited AEs include serious and non-serious AEs. Potential unsolicited AEs may have been medically attended (i.e. symptoms or illnesses requiring a hospitalization, or emergency room visit, or visit to/by a health care provider). Unsolicited AEs that were not medically attended nor perceived as a concern by participant are collected during interview with the participants and by review of available medical records at the next visit. An unsolicited adverse event is any event 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.
Measured: Within the 21-day follow-up period after Dose 2
Number of Participants With Any and Related Medically Attended Adverse Events (MAEs)
MAEs were defined as adverse events with medically-attended visits that are not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason.
Measured: Within the 21-day follow-up period after Dose 1
Number of Participants With Any and Related MAEs
MAEs were defined as adverse events with medically-attended visits that are not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason.
Measured: Within the 21-day follow-up period after Dose 2
Number of Participants With Any and Related Serious Adverse Events (SAEs)
A SAE is any untoward medical occurrence that results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization or result in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant. Abnormal pregnancy outcomes were also considered (e.g. spontaneous abortion, fatal death, stillbirth, congenital anomalies, ectopic pregnancy) or other situations where medical or scientific judgement was exercised in deciding whether reporting was appropriate.
Measured: From Day 1 up to Day 43
Number of Participants With Any and Related Potential Immune Mediated Diseases (pIMDs)
pIMDs are a subset of adverse events of special interest that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have had an autoimmune etiology.
Measured: From Day 1 up to Day 43
Number of Participants With Any pIMDs
pIMDs are a subset of adverse events of special interest that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have had an autoimmune etiology.
Measured: From Day 1 up to Month 13
Number of Participants With Any SAEs
A SAE is any untoward medical occurrence that results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization or result in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant. Abnormal pregnancy outcomes were also considered (e.g. spontaneous abortion, fatal death, stillbirth, congenital anomalies, ectopic pregnancy) or other situations where medical or scientific judgement was exercised in deciding whether reporting was appropriate.
Measured: From Day 1 up to Month 13

Secondary outcomes (8)

HI Antibody Titers Against Vaccine-homologous H7N9
HI antibody titers were expressed as Geometric Mean Titers (GMTs). The GMTs calculations were performed by taking the anti-log of the mean of the titer transformations. Values for titers below the assay cutoff will be assigned half the assay cut-off value for the purpose of GMT computation.
Note: The cut-off value for HI titer was defined by the laboratory before the analysis.
Measured: At Day 1, Day 22 and Day 43
Percentage of Seropositive Participants for HI Antibodies Against Vaccine-homologous H7N9
A seropositive participant is a participant whose antibody titer was greater than or equal to the assay cut-off value.
Note: The cut-off value for antibody titer was defined by the laboratory before the analysis.
Measured: At Day 1, Day 22 and Day 43
Percentage of Seroconverted Participants for HI Antibodies Against Vaccine-homologous H7N9
Seroconversion rate is defined as the percentage of participants with a post-vaccination antibody titer ≥40 1/DIL in the serum of participants seronegative before vaccination (i.e. titer < assay cut-off at Day 1). For seropositive participants (i.e. titer ≥ assay cut-off at Day 1), seroconversion required a 4-fold rise in post-vaccination HI antibody titer (but at least a titer of 40 1/DIL).
Note: The cut-off value for antibody titer was defined by the laboratory before the analysis.
Measured: At Day 22
Percentage of Seroprotected Participants for HI Antibodies Against Vaccine-homologous H7N9
SPR is defined as the percentage of participants with HI antibody titer ≥40 1/DIL.
Note: The cut-off value for antibody titer was defined by the laboratory before the analysis.
Measured: At Day 1 and Day 22
Mean Geometric Increase (MGI) of HI Antibody Titers Against Vaccine-homologous H7N9
MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 1): post-vaccination GMT over pre-vaccination GMT.
Measured: At Day 22 (post-Dose 1/pre-vaccination) and Day 43 (post-Dose 2/pre-vaccination)
Anti-microneutralization (MN) Antibody Titers Against Vaccine-homologous H7N9 for a Subset of Participants
Anti-MN antibody titers were expressed as GMTs. The GMTs calculations were performed by taking the antilog of the mean of the log titer transformations. Values for the neutralisation titers below the assay cut-off were assigned half the assay cut-off value for the purpose of GMT computation. MN analyses were performed on the MN subset that included approximately 420 participants (60 per group). The first 30 participants per treatment group were selected in the ≥65 age group and then the first 15 participants in 18 to 49 years and 50 to 64 years age groups. If there were not 15 participants for the 18 to 49 or 50 to 64 years age groups, they were selected whichever had the smaller number fully and then had a total of 30 for the total among these 2 age groups per treatment group. All samples were collected first, then selected for the subset.
Measured: At Day 1, Day 22 and Day 43
Percentage of Seropositive Participants for Vaccine-homologous H7N9 MN Antibody Titers for a Subset of Participants
A seropositive participant is a participant whose antibody titer was greater than or equal to the assay cut-off value.
Note: The cut-off value for antibody titer was defined by the laboratory before the analysis. MN analyses were performed on the MN subset.
Measured: At Day 1, Day 22 and Day 43
Vaccine Response Rate (VRR) of Anti-MN Antibodies Against Vaccine-homologous H7N9 for a Subset of Participants
VRR is expressed as the percentage of participants with a vaccine response defined as at least a 4-fold increase in antibody titer as compared to the antibody titer at Day 1 (pre-vaccination). Antibody titers below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of vaccine response calculation. For VRR, the percentage of participants was calculated with Clopper-Pearson exact two-sided 95% CIs. MN analyses were performed on the MN subset.
Measured: At Day 22 and Day 43

Timeline

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

16 Mar 202112 Sep 2022

First posted9 Mar 2021
Study start16 Mar 2021
Primary completion12 Sep 2022
Study completion12 Sep 2022

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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 833 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04789577
Sponsor's protocol ID: 209671
Status last verified: Sep 2023
First submitted: 5 Mar 2021
Last updated: 10 Oct 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
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

Hastie A, Clarke T, Germain S, Ollinger T, Lese P, Gupta V. Immunogenicity and Safety of AS03-Adjuvanted H7N9 Influenza Vaccine in Adults (18-64 and >/=65 Years): A Phase 1/2, Randomized, Placebo-Controlled Trial. Influenza Other Respir Viruses. 2024 Dec;18(12):e70020. doi: 10.1111/irv.70020.
PubMed 39702896

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?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I/II Observer-blind, Randomized, Placebo-controlled, Multi-center Trial to Evaluate the Safety and Immunogenicity of Different Formulations of Monovalent Influenza A/Hong Kong/125/2017-like (H7N9) Virus Vaccine With AS03 Adjuvant System, Given as a Two-dose Series to Adults 18 to 64 Years of Age and 65 Years of Age and Older
ClinicalTrials.gov ID: NCT04789577
Acronym / sponsor ID: 209671
Conditions: Influenza, Human
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 833 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 16 Mar 2021 (actual)
Primary completion: 12 Sep 2022 (actual)
Study completion: 12 Sep 2022 (actual)
First posted: 9 Mar 2021 (actual)
Results: Posted 10 Oct 2023

Clinical summary

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

Study to evaluate the safety and immunogenicity of H7N9 antigen in combination with full or half doses of AS03 adjuvant system in healthy adults.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 7

Arm	Type	Receives
FLU-Q-PAN H7N9 Formulation 1_B Group	Active comparator	Biological: FLU-Q-PAN H7N9 Formulation 1, Biological: AS03BHealthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
FLU-Q-PAN H7N9 Formulation 1_A Group	Active comparator	Biological: FLU-Q-PAN H7N9 Formulation 1, Biological: AS03AHealthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
FLU-Q-PAN H7N9 Formulation 2_B Group	Active comparator	Biological: FLU-Q-PAN H7N9 Formulation 2, Biological: AS03BHealthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
FLU-Q-PAN H7N9 Formulation 2_A Group	Active comparator	Biological: FLU-Q-PAN H7N9 Formulation 2, Biological: AS03AHealthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
FLU-Q-PAN H7N9 Formulation 3_B Group	Active comparator	Biological: FLU-Q-PAN H7N9 Formulation 3, Biological: AS03BHealthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
FLU-Q-PAN H7N9 Formulation 3_A Group	Active comparator	Biological: FLU-Q-PAN H7N9 Formulation 3, Biological: AS03AHealthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
Placebo Group	Placebo comparator	Drug: PlaceboHealthy male and female participants who received two doses of placebo, the first dose at Day 1 and the second dose at Day 22.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Healthy participants as established by medical history and clinical examination before entering into the study.
A male or female ≥ 18 years of age at the time of first vaccination.
Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards and COVID-19 assessment card, return for follow-up visits, or return the diary cards and COVID-19 assessment card in a timely manner using the pre stamped envelope received at the site).
Written or witnessed/thumb printed informed consent obtained from the participant prior to performance of any study specific procedure.
Female participants of non-childbearing potential may be enrolled in the study. Non childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion hysterectomy, bilateral ovariectomy or post-menopause.

Key exclusion criteria (27 listed)

Current diagnosis or history of autoimmune disorder(s).
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
Hypersensitivity to latex.
Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality that appears uncontrolled, as determined by history or physical examination.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).

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
FLU-Q-PAN H7N9 Formulation 1Participants received two doses of the FLU-Q-PAN H7N9 Formulation 1 vaccine by intramuscular injection in the non-dominant arm.	Biological	FLU-Q-PAN H7N9 Formulation 1_A Group, FLU-Q-PAN H7N9 Formulation 1_B Group
FLU-Q-PAN H7N9 Formulation 2Participants received two doses of the FLU-Q-PAN H7N9 Formulation 2 vaccine by intramuscular injection in the non-dominant arm.	Biological	FLU-Q-PAN H7N9 Formulation 2_A Group, FLU-Q-PAN H7N9 Formulation 2_B Group
FLU-Q-PAN H7N9 Formulation 3Participants received two doses of the FLU-Q-PAN H7N9 Formulation 3 vaccine by intramuscular injection in the non-dominant arm.	Biological	FLU-Q-PAN H7N9 Formulation 3_A Group, FLU-Q-PAN H7N9 Formulation 3_B Group
AS03BParticipants received two doses of the AS03B adjuvant by intramuscular injection in the non-dominant arm.	Biological	FLU-Q-PAN H7N9 Formulation 1_B Group, FLU-Q-PAN H7N9 Formulation 2_B Group, FLU-Q-PAN H7N9 Formulation 3_B Group
AS03AParticipants received two doses of the AS03A adjuvant by intramuscular injection in the non-dominant arm.	Biological	FLU-Q-PAN H7N9 Formulation 1_A Group, FLU-Q-PAN H7N9 Formulation 2_A Group, FLU-Q-PAN H7N9 Formulation 3_A Group
PlaceboParticipants received two doses of Placebo by intramuscular injection in the non-dominant arm.	Drug	Placebo Group

Primary outcome

Percentage of Seroprotected Participants for Anti-hemagglutination Inhibition (HI) Antibodies Against Vaccine-homologous H7N9
Time frame: At Day 43
Center for Biologics Evaluation and Research (CBER) criteria for seroprotection rate (SPR) for 18 to 64 years of age is shown if the Lower Limit (LL) of the 99.17% confidence interval (CI) for the SPR meets or exceeds 70%, and for greater than or equal to (≥) 65 years of age if the LL of the 99.17% CI for the SPR meets or exceeds 60%. SPR is defined as the percentage of participants with an HI antibody titer ≥40 1/dilution (DIL). The percentage of participants was calculated along with Clopper-Pearson exact two-sided 99.17% CIs.
Percentage of Seroconverted Participants for Anti-HI Antibodies Against Vaccine-homologous H7N9
Time frame: At Day 43
CBER criteria for seroconversion rate (SCR) for 18 to 64 years of age is shown if LL of the 99.17% CI for the SCR meets or exceeds 40%, and for ≥65 years of age, if the LL of the 99.17% CI for the SCR meets or exceeds 30%. Seroconversion is defined as a post-vaccination antibody titer ≥40 1/DIL in the serum of participants seronegative before vaccination (i.e. titer < assay cut-off at Day 1). For seropositive participants (i.e. titer ≥ assay cut-off at Day 1), seroconversion requires a 4-fold rise in post-vaccination HI antibody titer (but at least a titer of 40 1/DIL). The percentage of participants was calculated with Clopper-Pearson exact two-sided 99.17% CIs. Note: The cut-off value for antibody titer was defined by the laboratory before the analysis.
Number of Participants With Any Solicited Administration Site Events
Time frame: Within the 7-day follow-up period after Dose 1
Solicited administered site events assessed were pain, redness and swelling. Any Pain = occurrence of symptom regardless of intensity grade. Any Redness or any Swelling symptom = any symptom having a surface diameter greater than (>) 20 millimeters (mm).
Number of Participants With Any Solicited Administration Site Events
Time frame: Within the 7-day follow-up period after Dose 2
Solicited administered site events assessed were pain, redness and swelling. Any Pain = occurrence of symptom regardless of intensity grade. Any Redness or any Swelling symptom = any symptom having a surface diameter >20 mm.
Number of Participants With Any Solicited Systemic Events
Time frame: Within the 7-day follow-up period after Dose 1
Solicited systemic events assessed were fatigue, fever, headache, muscle ache all over body, joint pain, shivering, sweating and gastrointestinal symptoms (Nausea, vomiting, diarrhea and abdominal pain). Any = occurrence of symptom regardless of intensity grade. Fever was defined as temperature ≥38 degrees Celsius (°C) for oral route (preferred location for measuring temperature).
Number of Participants With Any Solicited Systemic Events
Time frame: Within the 7-day follow-up period after Dose 2
Solicited systemic events assessed were fatigue, fever, headache, muscle ache all over body, joint pain, shivering, sweating and gastrointestinal symptoms (Nausea, vomiting, diarrhea and abdominal pain). Any = occurrence of symptom regardless of intensity grade. Fever was defined as temperature ≥38°C for oral route (preferred location for measuring temperature).
Number of Participants With Any and Related Unsolicited Adverse Events
Time frame: Within the 21-day follow-up period after Dose 1
An unsolicited adverse event (AE) is an AE that was not solicited using a Participant Diary and that was spontaneously communicated by a participant who had signed the informed consent. Unsolicited AEs include serious and non-serious AEs. Potential unsolicited AEs may have been medically attended (i.e. symptoms or illnesses requiring a hospitalization, or emergency room visit, or visit to/by a health care provider). Unsolicited AEs that were not medically attended nor perceived as a concern by participant were collected during interview with the participants and by review of available medical records at the following visit. An unsolicited adverse event is any event 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.
Number of Participants With Any and Related Unsolicited Adverse Events
Time frame: Within the 21-day follow-up period after Dose 2
An unsolicited AE is an AE that was not solicited using a Participant Diary and that was spontaneously communicated by a participant who has signed the informed consent. Unsolicited AEs include serious and non-serious AEs. Potential unsolicited AEs may have been medically attended (i.e. symptoms or illnesses requiring a hospitalization, or emergency room visit, or visit to/by a health care provider). Unsolicited AEs that were not medically attended nor perceived as a concern by participant are collected during interview with the participants and by review of available medical records at the next visit. An unsolicited adverse event is any event 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.
Number of Participants With Any and Related Medically Attended Adverse Events (MAEs)
Time frame: Within the 21-day follow-up period after Dose 1
MAEs were defined as adverse events with medically-attended visits that are not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason.
Number of Participants With Any and Related MAEs
Time frame: Within the 21-day follow-up period after Dose 2
MAEs were defined as adverse events with medically-attended visits that are not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason.
Number of Participants With Any and Related Serious Adverse Events (SAEs)
Time frame: From Day 1 up to Day 43
A SAE is any untoward medical occurrence that results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization or result in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant. Abnormal pregnancy outcomes were also considered (e.g. spontaneous abortion, fatal death, stillbirth, congenital anomalies, ectopic pregnancy) or other situations where medical or scientific judgement was exercised in deciding whether reporting was appropriate.
Number of Participants With Any and Related Potential Immune Mediated Diseases (pIMDs)
Time frame: From Day 1 up to Day 43
pIMDs are a subset of adverse events of special interest that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have had an autoimmune etiology.
Number of Participants With Any pIMDs
Time frame: From Day 1 up to Month 13
pIMDs are a subset of adverse events of special interest that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have had an autoimmune etiology.
Number of Participants With Any SAEs
Time frame: From Day 1 up to Month 13
A SAE is any untoward medical occurrence that results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization or result in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant. Abnormal pregnancy outcomes were also considered (e.g. spontaneous abortion, fatal death, stillbirth, congenital anomalies, ectopic pregnancy) or other situations where medical or scientific judgement was exercised in deciding whether reporting was appropriate.

8 secondary outcomes

HI Antibody Titers Against Vaccine-homologous H7N9
Time frame: At Day 1, Day 22 and Day 43
Percentage of Seropositive Participants for HI Antibodies Against Vaccine-homologous H7N9
Time frame: At Day 1, Day 22 and Day 43
Percentage of Seroconverted Participants for HI Antibodies Against Vaccine-homologous H7N9
Time frame: At Day 22
Percentage of Seroprotected Participants for HI Antibodies Against Vaccine-homologous H7N9
Time frame: At Day 1 and Day 22
Mean Geometric Increase (MGI) of HI Antibody Titers Against Vaccine-homologous H7N9
Time frame: At Day 22 (post-Dose 1/pre-vaccination) and Day 43 (post-Dose 2/pre-vaccination)
Anti-microneutralization (MN) Antibody Titers Against Vaccine-homologous H7N9 for a Subset of Participants
Time frame: At Day 1, Day 22 and Day 43
Percentage of Seropositive Participants for Vaccine-homologous H7N9 MN Antibody Titers for a Subset of Participants
Time frame: At Day 1, Day 22 and Day 43
Vaccine Response Rate (VRR) of Anti-MN Antibodies Against Vaccine-homologous H7N9 for a Subset of Participants
Time frame: At Day 22 and Day 43

Results and safety

Results posted to the registry on 10 Oct 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
FLU-Q-PAN H7N9 Formulation 1_B Group	121	113
FLU-Q-PAN H7N9 Formulation 1_A Group	116	103
FLU-Q-PAN H7N9 Formulation 2_B Group	119	111
FLU-Q-PAN H7N9 Formulation 2_A Group	119	105
FLU-Q-PAN H7N9 Formulation 3_B Group	117	108
FLU-Q-PAN H7N9 Formulation 3_A Group	121	107
Placebo Group	120	109

Primary outcome: Percentage of Seroprotected Participants for Anti-hemagglutination Inhibition (HI) Antibodies Against Vaccine-homologous H7N9

Time frame: At Day 43. Number (99.17% Confidence Interval). Unit: Percentage of Participants

Measure	FLU-Q-PAN H7N9 Formulation 1_B Group n = 98	FLU-Q-PAN H7N9 Formulation 1_A Group n = 93	FLU-Q-PAN H7N9 Formulation 2_B Group n = 97	FLU-Q-PAN H7N9 Formulation 2_A Group n = 94	FLU-Q-PAN H7N9 Formulation 3_B Group n = 101	FLU-Q-PAN H7N9 Formulation 3_A Group n = 94	Placebo Group n = 95
Value	27.1 (16.1 to 40.6)	27.7 (15.8 to 42.4)	23.5 (12.7 to 37.6)	26.5 (14.9 to 41.1)	19.1 (9.5 to 32.3)	40.5 (26.7 to 55.4)	0 (0 to 0)

Population analysed: Analysis was performed on the Per Protocol Set (PPS), which included all participants with no major protocol deviations that lead to exclusion at or prior to Day 43, who had data collected for anti-HI antibodies, at each visit and for whom post-vaccination immunogenicity data was available at Day 43.

Primary outcome: Percentage of Seroconverted Participants for Anti-HI Antibodies Against Vaccine-homologous H7N9

Time frame: At Day 43. Number (99.17% Confidence Interval). Unit: Percentage of Participants

Measure	FLU-Q-PAN H7N9 Formulation 1_B Group n = 98	FLU-Q-PAN H7N9 Formulation 1_A Group n = 93	FLU-Q-PAN H7N9 Formulation 2_B Group n = 97	FLU-Q-PAN H7N9 Formulation 2_A Group n = 94	FLU-Q-PAN H7N9 Formulation 3_B Group n = 101	FLU-Q-PAN H7N9 Formulation 3_A Group n = 94	Placebo Group n = 95
Value	27.1 (16.1 to 40.6)	27.7 (15.8 to 42.4)	23.5 (12.7 to 37.6)	26.5 (14.9 to 41.1)	19.1 (9.5 to 32.3)	40.5 (26.7 to 55.4)	0 (0 to 0)

Primary outcome: Number of Participants With Any Solicited Administration Site Events

Time frame: Within the 7-day follow-up period after Dose 1. Count of participants. Unit: Participants

Measure	FLU-Q-PAN H7N9 Formulation 1_B Group n = 121	FLU-Q-PAN H7N9 Formulation 1_A Group n = 113	FLU-Q-PAN H7N9 Formulation 2_B Group n = 117	FLU-Q-PAN H7N9 Formulation 2_A Group n = 117	FLU-Q-PAN H7N9 Formulation 3_B Group n = 114	FLU-Q-PAN H7N9 Formulation 3_A Group n = 115	Placebo Group n = 118
Any Pain	72	77	68	80	53	78	15
Any Redness	1	3	2	5	0	2	0
Any Swelling	1	6	4	5	0	2	0

Population analysed: Analysis was performed on the Exposed Set, which included all participants who received the first dose of study intervention and had solicited administration site adverse events data.

Primary outcome: Number of Participants With Any Solicited Administration Site Events

Time frame: Within the 7-day follow-up period after Dose 2. Count of participants. Unit: Participants

Measure	FLU-Q-PAN H7N9 Formulation 1_B Group n = 112	FLU-Q-PAN H7N9 Formulation 1_A Group n = 107	FLU-Q-PAN H7N9 Formulation 2_B Group n = 112	FLU-Q-PAN H7N9 Formulation 2_A Group n = 108	FLU-Q-PAN H7N9 Formulation 3_B Group n = 106	FLU-Q-PAN H7N9 Formulation 3_A Group n = 105	Placebo Group n = 111
Any Pain	53	62	58	66	42	56	13
Any Redness	1	3	0	3	1	2	0
Any Swelling	4	8	1	5	1	4	0

Population analysed: Analysis was performed on the Exposed Set, which included all participants who received the second dose of study intervention and had solicited administration site adverse events data.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FLU-Q-PAN H7N9 Formulation 1_B Group	3 of 121 (2.5%)	40 of 121 (33.1%)	0 of 121
FLU-Q-PAN H7N9 Formulation 1_A Group	3 of 116 (2.6%)	32 of 116 (27.6%)	0 of 116
FLU-Q-PAN H7N9 Formulation 2_B Group	10 of 119 (8.4%)	33 of 119 (27.7%)	0 of 119
FLU-Q-PAN H7N9 Formulation 2_A Group	4 of 119 (3.4%)	34 of 119 (28.6%)	0 of 119
FLU-Q-PAN H7N9 Formulation 3_B Group	6 of 117 (5.1%)	30 of 117 (25.6%)	0 of 117
FLU-Q-PAN H7N9 Formulation 3_A Group	5 of 121 (4.1%)	39 of 121 (32.2%)	0 of 121
Placebo Group	7 of 120 (5.8%)	33 of 120 (27.5%)	0 of 120

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39702896Hastie A, Clarke T, Germain S, Ollinger T, Lese P, Gupta V. Immunogenicity and Safety of AS03-Adjuvanted H7N9 Influenza Vaccine in Adults (18-64 and >/=65 Years): A Phase 1/2, Randomized, Placebo-Controlled Trial. Influenza Other Respir Viruses. 2024 Dec;18(12):e70020. doi: 10.1111/irv.70020.
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

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 27 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 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 10 Oct 2023). 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?

Percentage of Seroprotected Participants for Anti-hemagglutination Inhibition (HI) Antibodies Against Vaccine-homologous H7N9 (time frame: At Day 43). The study lists 14 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 NCT04789577, 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 10 Oct 2023.