InfluenzaPhase 2NCT01949090

Immunogenicity and Safety Study of Different Formulations of GlaxoSmithKline (GSK) Biologicals H7N1 Influenza Vaccine Administered to Adults 65 Years of Age and Older

A Phase 2 study testing Investigational H7N1 vaccine GSK2789869A in people with Influenza, run by GlaxoSmithKline at 8 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 placebo controlled study is to evaluate the safety and immunogenicity of different formulations of GSK Biologicals H7N1 influenza vaccine in subjects 65 years of age and older. The study will evaluate safety related events and antibody immune responses to different formulations of study vaccine. Read more about this study

Who is it for?: Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: Investigational H7N1 vaccine GSK2789869A
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 363 participants
Where: 8 sitesin 2 countries
Study dates: 25 Sep 2013to 23 Oct 2014
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 65 years and older
All sexes
Healthy volunteers accepted
Older adult

Who may be able to join

Male or female adults who are 65 years of age and older at the time of first study vaccination.
Written informed consent obtained from the subject.
Subjects who the investigator believes can and will comply with the requirements of the protocol.
Stable health status, as established by medical history and physical exam, and defined by absence of a health event satisfying the definition of a serious adverse event, or a change in an ongoing drug therapy due to therapeutic failure or symptoms of drug toxicity, within 1 month prior to enrollment.
Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or other multiple-user device.

Who cannot join

Presence or evidence of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
Presence or evidence of substance abuse.
Diagnosed with cancer, or treatment for cancer within three years.
Persons with a history of cancer who are disease-free without treatment for three 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 excepted and are eligible, but other histologic types of skin cancer are exclusionary.
Women who are disease-free three years or more after treatment for breast cancer and receiving long-term prophylaxis are eligible.

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Diagnosed with excessive daytime sleepiness (unintended sleep episodes during the day present almost daily for at least one month), or narcolepsy; or history of narcolepsy in subject's parent, sibling or child.
Presence of a temperature ≥ 38.0ºC (≥100.4ºF), or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.
Receipt of systemic glucocorticoids within 30 days prior to the first dose of study vaccine/placebo, or any other cytotoxic, immunosuppressive or immune-modifying drugs within 6 months of first study vaccine/placebo dose. Topical, intra-articularly injected, or inhaled glucocorticoids, topical calcineurin inhibitors or imiquimod are allowed.
Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin outside of 24 hours prior to vaccination are eligible. Persons receiving prophylactic antiplatelet medications, e.g., low-dose aspirin, and without a clinically-apparent bleeding tendency, are eligible.
An acute evolving neurological disorder or Guillain Barré Syndrome within 42 days of receipt of prior seasonal or pandemic influenza vaccine.
Administration of an inactive vaccine within 14 days or of a live attenuated vaccine within 30 days before the first dose of study vaccine/placebo.
Planned administration of any vaccine other than the study vaccine/placebo before blood sampling at the Day 42 visit.
Previous administration of any H7 vaccine or physician-confirmed H7 disease.
Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine/placebo, or planned use during the study period.
Receipt of any immunoglobulins and/or any blood products within 90 days before the first dose of study vaccine/placebo, or planned administration of any of these products during the study period.
Any known or suspected allergy to any constituent of influenza vaccines or component used in the manufacturing process of the study vaccine including a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.

Trial locations and contacts

8 sites in 2 countries.

Country

City, postcode or hospital

8 sites in 2 countries

United States5 sites

GSK Investigational Site
Hollywood, Florida, 33024
GSK Investigational Site
Lenexa, Kansas, 66219
GSK Investigational Site
Lexington, Kentucky, 40509
GSK Investigational Site
Meridian, Idaho, 83642
GSK Investigational Site
Wichita, Kansas, 67207

Other trials in United States

Canada3 sites

GSK Investigational Site
Greater Sudbury, Ontario, P3E 1H5
GSK Investigational Site
Toronto, Ontario, M9W 4L6
GSK Investigational Site
Truro, Nova Scotia, B2N 1L2

Other trials in Canada

About this study

Official title: An Observer-blind Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine(s) GSK2789869A Administered in Adults 65 Years of Age and Older

Conditions: Influenza
Being tested: Investigational H7N1 vaccine GSK2789869A, Placebo
Keywords: H7N1, AS03 adjuvant, Safety, Immunogenicity, Influenza, Adults, Elderly adults
Medical subject headings: Influenza, Human

What participants receive

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

Investigational H7N1 vaccine GSK2789869ABiological
Two doses of GSK2789869A H7N1 vaccine administered intramuscularly to the deltoid region at Day 0 and Day 21.
PlaceboBiological
Two doses of placebo administered intramuscularly to the deltoid region at Day 0 and Day 21.

Study groups in NCT01949090
Study group	Role	What they receive
GSK2789869A F1 Group	Experimental	Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. Receives: Biological: Investigational H7N1 vaccine GSK2789869A
GSK2789869A F2 Group	Experimental	Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. Receives: Biological: Investigational H7N1 vaccine GSK2789869A
GSK2789869A F3 Group	Experimental	Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. Receives: Biological: Investigational H7N1 vaccine GSK2789869A
GSK2789869A F4 Group	Experimental	Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. Receives: Biological: Investigational H7N1 vaccine GSK2789869A
Placebo Group	Placebo comparator	Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. Receives: Biological: Placebo

What is being measured

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

Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain
Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 10 post-vaccination], antibody titer greater than or equal to (≥) 40 after vaccination; For initially seropositive subjects (antibody titer ≥ 10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/mallard/Netherlands/12/2000 NIBRG-63 (H7N1) (Flu A/mallard/NL/12/2000 H7N1).
Measured: At Day 42
Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain
A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection.
Measured: At Day 42
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain
GMFR, also known as seroconversion factor (SCR) or mean geometric increase (MGI), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer for the vaccine virus.
Measured: At Day 42
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest; prevented normal activities as assessed by inability to attend/do work or school. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Measured: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (symptoms included nausea, vomiting, diarrhoea and/or abdominal pain), headache, joint pain at other location, muscle aches, shivering, sweating and fever [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = general symptom that prevented normal everyday activities as assessed by inability to attend/do work or school, or required intervention of a physician/healthcare provider. Grade 3 fever = temperature > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Measured: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values
Among analysed biochemical parameters were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CRE], eosinophils [EOS], hematocrit [HEM], hemoglobin [HgB], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC].
Measured: At Day 0
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values
Among analysed biochemical parameters were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CRE], eosinophils [EOS], hematocrit [HEM], hemoglobin [HgB], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC].
Measured: At Day 7
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values
Among analysed biochemical parameters were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CRE], eosinophils [EOS], hematocrit [HEM], hemoglobin [HgB], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC].
Measured: At Day 21
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values
Among analysed biochemical parameters were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CRE], eosinophils [EOS], hematocrit [HEM], hemoglobin [HgB], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC].
Measured: At Day 28
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values
Among analysed biochemical parameters were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CRE], eosinophils [EOS], hematocrit [HEM], hemoglobin [HgB], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC].
Measured: At Day 42
Number of Subjects With Any Medically-attended Adverse Events (MAEs)
MAEs were defined as events for which the subject received 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: From Day 0 up to Day 42
Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs)
Any pIMD was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.
Measured: From Day 0 up to Day 42
Number of Subjects With Any Unsolicited Adverse Events (AEs)
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 was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Measured: From Day 0 up to Day 42
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Measured: From Day 0 up to Day 42

Secondary outcomes (20)

Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1)
Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/mallard/NL/12/2000 (H7N1).
Measured: At Days 0, 21, 42 and Months 6 and 12
Titers for Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1)
Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was Flu A/mallard/NL/12/2000 (H7N1).
Measured: At Days 0, 21, 42 and Months 6 and 12
Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-homologous (H7N1)
Seroprotection (SPR) was defined as the proportion of subjects with H7N1 reciprocal HI titers equal to or above (≥) 1:40 against the tested vaccine virus. The flu strain assessed was Flu A/mallard/NL/12/2000 (H7N1).
Measured: At Days 0, 21 and 42 and at Months 6 and 12
Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-homologous (H7N1)
SCR was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post-vaccination reciprocal titer against the vaccine virus. The flu strain assessed was Flu A/mallard/NL/12/2000 (H7N1).
Measured: At Days 21 and 42 and at Months 6 and 12
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1)
GMFR, also known as seroconversion factor (SCF), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The flu strain assessed was Flu A/mallard/NL/12/2000 (H7N1).
Measured: At Days 21 and 42 and at Months 6 and 12
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9)
Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/Shanghai/2/2013 (H7N9).
Measured: At Days 0, 21 and 42 and at Months 6 and 12
Titers for Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9)
Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was Flu A/Shanghai/2/2013 (H7N9).
Measured: At Days 0, 21 and 42 and at Months 6 and 12
Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-heterologous (H7N9)
Seroprotection (SPR) was defined as the proportion of subjects with H7N9 reciprocal HI titers equal to or above (≥) 1:40 against the tested vaccine virus. The flu strain assessed was Flu A/Shanghai/2/2013 (H7N9).
Measured: At Days 0, 21 and 42 and at Months 6 and 12
Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-heterologous (H7N9)
SCR was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post-vaccination reciprocal titer against the vaccine virus. The flu strain assessed was Flu A/Shanghai/2/2013 (H7N9).
Measured: At Days 21 and 42 and at Months 6 and 12
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9)
GMFR, also known as seroconversion factor (SCF), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The flu strain assessed was Flu A/Shanghai/2/2013 (H7N9).
Measured: At Days 21 and 42 and at Months 6 and 12
Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1)
Seropositivity cut-off values assessed were equal to or above (≥) 1:28 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/mallard/NL/12/2000 (H7N1).
Measured: At Days 0, 21 and 42 and Month 6
Titers for Serum Neutralizing Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1)
Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/mallard/NL/12/2000. The reference seropositivity cut-off value was ≥ 1:28.
Measured: At Days 0, 21 and 42 and at Month 6
Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain
Vaccine response was defined as: For initially seronegative subjects antibody titer ≥ 1:56 at post-vaccination]; For initially seropositive subjects antibody titer at post-vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was Flu A/mallard/NL/12/2000 (H7N1).
Measured: At Days 21 and 42 and at Month 6
Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9)
Seropositivity cut-off values assessed were equal to or above (≥) 1:28 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/Anhui/1/2013 (H7N9).
Measured: At Days 0, 21 and 42 and at Month 6
Titers for Antibodies Against Flu A/Anhui/1/2013 Strain of Influenza Disease Vaccine-homologous (H7N9)
Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/Anhui/1/2013. The reference seropositivity cut-off value was ≥ 1:28.
Measured: At Days 0, 21 and 42 and at Month 6
Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the Flu A/Anhui/1/2013 (H7N9) Virus Strain
Vaccine response was defined as: For initially seronegative subjects antibody titer ≥ 1:56 at post-vaccination]; For initially seropositive subjects antibody titer at post-vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was Flu A/Anhui/1/2013 (H7N9).
Measured: At Days 21 and 42 and at Month 6
Number of Subjects With Any Medically-attended Adverse Events (MAEs)
MAEs were defined as events for which the subject received 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. Analysis of intensity and relationship to vaccination of MAEs was not performed.
Measured: From Day 42 up to Month 12
Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs)
An pIMD was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.
Measured: From Day 42 up to Month 12
Number of Subjects With Any Unsolicited Adverse Events (AEs)
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 was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Measured: During the 21-day (From Day 0 to Day 20) post-vaccination period after each dose
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed 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 0 up to Month 12)

Timeline

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

25 Sep 201323 Oct 2014

First posted24 Sep 2013 (estimated)
Study start25 Sep 2013
Primary completion4 Dec 2013
Study completion23 Oct 2014

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 InfluenzaStudies 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: 363 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01949090
Sponsor's protocol ID: 200613
Status last verified: Nov 2017
First submitted: 19 Sep 2013
Last updated: 17 Nov 2017
Results posted: Yes, on ClinicalTrials.gov

Publications

Madan A, Ferguson M, Rheault P, Seiden D, Toma A, Friel D, Soni J, Li P, Innis BL, Schuind A. Immunogenicity and safety of an AS03-adjuvanted H7N1 vaccine in adults 65years of age and older: A phase II, observer-blind, randomized, controlled trial. Vaccine. 2017 Apr 4;35(15):1865-1872. doi: 10.1016/j.vaccine.2017.02.057. Epub 2017 Mar 13.
PubMed 28302407

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 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Observer-blind Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine(s) GSK2789869A Administered in Adults 65 Years of Age and Older
ClinicalTrials.gov ID: NCT01949090
Acronym / sponsor ID: 200613
Conditions: Influenza
Keywords: H7N1, AS03 adjuvant, Safety, Immunogenicity, Influenza, Adults, Elderly adults
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 363 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 25 Sep 2013 (actual)
Primary completion: 4 Dec 2013 (actual)
Study completion: 23 Oct 2014 (actual)
First posted: 24 Sep 2013 (estimated)
Results: Posted 17 Nov 2017

Clinical summary

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
GSK2789869A F1 Group	Experimental	Biological: Investigational H7N1 vaccine GSK2789869AHealthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
GSK2789869A F2 Group	Experimental	Biological: Investigational H7N1 vaccine GSK2789869AHealthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
GSK2789869A F3 Group	Experimental	Biological: Investigational H7N1 vaccine GSK2789869AHealthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
GSK2789869A F4 Group	Experimental	Biological: Investigational H7N1 vaccine GSK2789869AHealthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Placebo Group	Placebo comparator	Biological: PlaceboHealthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Older adult

Key inclusion criteria (5 listed)

Male or female adults who are 65 years of age and older at the time of first study vaccination.
Written informed consent obtained from the subject.
Subjects who the investigator believes can and will comply with the requirements of the protocol.
Stable health status, as established by medical history and physical exam, and defined by absence of a health event satisfying the definition of a serious adverse event, or a change in an ongoing drug therapy due to therapeutic failure or symptoms of drug toxicity, within 1 month prior to enrollment.
Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or other multiple-user device.

Key exclusion criteria (19 listed)

Presence or evidence of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
Presence or evidence of substance abuse.
Diagnosed with cancer, or treatment for cancer within three years.
Diagnosed with excessive daytime sleepiness (unintended sleep episodes during the day present almost daily for at least one month), or narcolepsy; or history of narcolepsy in subject's parent, sibling or child.
Presence of a temperature ≥ 38.0ºC (≥100.4ºF), or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.

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
Investigational H7N1 vaccine GSK2789869ATwo doses of GSK2789869A H7N1 vaccine administered intramuscularly to the deltoid region at Day 0 and Day 21.	Biological	GSK2789869A F1 Group, GSK2789869A F2 Group, GSK2789869A F3 Group, GSK2789869A F4 Group
PlaceboTwo doses of placebo administered intramuscularly to the deltoid region at Day 0 and Day 21.	Biological	Placebo Group

Primary outcome

Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain
Time frame: At Day 42
Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 10 post-vaccination], antibody titer greater than or equal to (≥) 40 after vaccination; For initially seropositive subjects (antibody titer ≥ 10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/mallard/Netherlands/12/2000 NIBRG-63 (H7N1) (Flu A/mallard/NL/12/2000 H7N1).
Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain
Time frame: At Day 42
A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection.
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain
Time frame: At Day 42
GMFR, also known as seroconversion factor (SCR) or mean geometric increase (MGI), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer for the vaccine virus.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest; prevented normal activities as assessed by inability to attend/do work or school. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (symptoms included nausea, vomiting, diarrhoea and/or abdominal pain), headache, joint pain at other location, muscle aches, shivering, sweating and fever [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = general symptom that prevented normal everyday activities as assessed by inability to attend/do work or school, or required intervention of a physician/healthcare provider. Grade 3 fever = temperature > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values
Time frame: At Day 0
Among analysed biochemical parameters were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CRE], eosinophils [EOS], hematocrit [HEM], hemoglobin [HgB], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC].
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values
Time frame: At Day 7
Among analysed biochemical parameters were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CRE], eosinophils [EOS], hematocrit [HEM], hemoglobin [HgB], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC].
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values
Time frame: At Day 21
Among analysed biochemical parameters were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CRE], eosinophils [EOS], hematocrit [HEM], hemoglobin [HgB], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC].
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values
Time frame: At Day 28
Among analysed biochemical parameters were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CRE], eosinophils [EOS], hematocrit [HEM], hemoglobin [HgB], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC].
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values
Time frame: At Day 42
Among analysed biochemical parameters were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CRE], eosinophils [EOS], hematocrit [HEM], hemoglobin [HgB], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC].
Number of Subjects With Any Medically-attended Adverse Events (MAEs)
Time frame: From Day 0 up to Day 42
MAEs were defined as events for which the subject received 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 With Any Potential Immune-mediated Diseases (pIMDs)
Time frame: From Day 0 up to Day 42
Any pIMD was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.
Number of Subjects With Any Unsolicited Adverse Events (AEs)
Time frame: From Day 0 up to Day 42
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 was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: From Day 0 up to Day 42
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

20 secondary outcomes

Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1)
Time frame: At Days 0, 21, 42 and Months 6 and 12
Titers for Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1)
Time frame: At Days 0, 21, 42 and Months 6 and 12
Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-homologous (H7N1)
Time frame: At Days 0, 21 and 42 and at Months 6 and 12
Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-homologous (H7N1)
Time frame: At Days 21 and 42 and at Months 6 and 12
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1)
Time frame: At Days 21 and 42 and at Months 6 and 12
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9)
Time frame: At Days 0, 21 and 42 and at Months 6 and 12
Titers for Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9)
Time frame: At Days 0, 21 and 42 and at Months 6 and 12
Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-heterologous (H7N9)
Time frame: At Days 0, 21 and 42 and at Months 6 and 12
Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-heterologous (H7N9)
Time frame: At Days 21 and 42 and at Months 6 and 12
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9)
Time frame: At Days 21 and 42 and at Months 6 and 12
Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1)
Time frame: At Days 0, 21 and 42 and Month 6
Titers for Serum Neutralizing Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1)
Time frame: At Days 0, 21 and 42 and at Month 6
Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain
Time frame: At Days 21 and 42 and at Month 6
Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9)
Time frame: At Days 0, 21 and 42 and at Month 6
Titers for Antibodies Against Flu A/Anhui/1/2013 Strain of Influenza Disease Vaccine-homologous (H7N9)
Time frame: At Days 0, 21 and 42 and at Month 6
Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the Flu A/Anhui/1/2013 (H7N9) Virus Strain
Time frame: At Days 21 and 42 and at Month 6
Number of Subjects With Any Medically-attended Adverse Events (MAEs)
Time frame: From Day 42 up to Month 12
Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs)
Time frame: From Day 42 up to Month 12
Number of Subjects With Any Unsolicited Adverse Events (AEs)
Time frame: During the 21-day (From Day 0 to Day 20) post-vaccination period after each dose
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: During the entire study period (From Day 0 up to Month 12)

Results and safety

Results posted to the registry on 17 Nov 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GSK2789869A F1 Group	60	56
GSK2789869A F2 Group	60	58
GSK2789869A F3 Group	60	58
GSK2789869A F4 Group	60	59
Placebo Group	120	116

Primary outcome: Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain

Time frame: At Day 42. Count of participants. Unit: Participants

Measure	GSK2789869A F1 Group n = 56	GSK2789869A F2 Group n = 56	GSK2789869A F3 Group n = 55	GSK2789869A F4 Group n = 53	Placebo Group n = 112
Value	39	45	42	46	0

Population analysed: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects for whom data concerning immunogenicity outcome measure were available. This primary outcome measure was centered on the groups that received GSK2789869A vaccine.

Primary outcome: Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain

Time frame: At Day 42. Count of participants. Unit: Participants

Measure	GSK2789869A F1 Group n = 56	GSK2789869A F2 Group n = 56	GSK2789869A F3 Group n = 55	GSK2789869A F4 Group n = 53	Placebo Group n = 112
Value	39	49	43	47	1

Population analysed: The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom data concerning immunogenicity outcome measure were available. This primary outcome measure was centered on the groups that received GSK2789869A vaccine.

Primary outcome: Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain

Time frame: At Day 42. Geometric mean (95% Confidence Interval). Unit: Fold increase

Measure	GSK2789869A F1 Group n = 56	GSK2789869A F2 Group n = 56	GSK2789869A F3 Group n = 55	GSK2789869A F4 Group n = 53	Placebo Group n = 112
Value	11.0 (7.3 to 16.5)	18.9 (14.0 to 25.4)	16.0 (10.8 to 23.7)	18.2 (12.6 to 26.3)	1.0 (1.0 to 1.1)

Population analysed: The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom data concerning immunogenicity outcome measure were available. This primary outcome was centered on the groups that received GSK2789869A vaccine.

Primary outcome: Number of Subjects With Any and Grade 3 Solicited Local Symptoms

Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses. Count of participants. Unit: Participants

Measure	GSK2789869A F1 Group n = 60	GSK2789869A F2 Group n = 60	GSK2789869A F3 Group n = 60	GSK2789869A F4 Group n = 60	Placebo Group n = 120
Any Pain, Dose 1	27	34	16	29	7
Grade 3 Pain, Dose 1	0	1	0	1	0
Any Redness, Dose 1	0	3	1	4	1
Grade 3 Redness, Dose 1	0	0	0	0	0
Any Swelling, Dose 1	1	1	3	2	0
Grade 3 Swelling, Dose 1	0	0	0	0	0
Any Pain, Dose 2	27	24	17	25	3
Grade 3 Pain, Dose 2	0	0	2	0	1

Population analysed: The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available.

20 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GSK2789869A F1 Group	3 of 60 (5%)	46 of 60 (76.7%)	0 of 60
GSK2789869A F2 Group	10 of 60 (16.7%)	48 of 60 (80%)	1 of 60
GSK2789869A F3 Group	7 of 60 (11.7%)	30 of 60 (50%)	2 of 60
GSK2789869A F4 Group	7 of 60 (11.7%)	44 of 60 (73.3%)	0 of 60
Placebo Group	13 of 120 (10.8%)	47 of 120 (39.2%)	0 of 120

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28302407Madan A, Ferguson M, Rheault P, Seiden D, Toma A, Friel D, Soni J, Li P, Innis BL, Schuind A. Immunogenicity and safety of an AS03-adjuvanted H7N1 vaccine in adults 65years of age and older: A phase II, observer-blind, randomized, controlled trial. Vaccine. 2017 Apr 4;35(15):1865-1872. doi: 10.1016/j.vaccine.2017.02.057. Epub 2017 Mar 13.

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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 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Investigational H7N1 vaccine GSK2789869A in people with Influenza, run by GlaxoSmithKline at 8 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 5 inclusion and 19 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 17 Nov 2017. 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, Canada. 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 17 Nov 2017). 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 Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain (time frame: At Day 42). 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 NCT01949090, 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 17 Nov 2017.