CompletedNCT01934127Updated May 8, 2017

Immunogenicity and Safety Study of Different Formulations of GlaxoSmithKline (GSK) Biologicals H7N1 Influenza Vaccine Administered to Adults 21 to 64 Years of Age

A Phase 1 interventional study of Investigational H7N1 vaccine GSK2789869A and Investigational H7N1 vaccine GSK2789868A in Influenza, sponsored by GlaxoSmithKline. Completed at 9 sites in 2 countries. Open to participants aged 21 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-08.

Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Prevention

Phase: Phase 1
Study type: Interventional
Enrollment: 427
Allocation: Randomized
Ages: 21 Years to 64 Years
Sex: All

Study summary

The purpose of this study is to evaluate the safety and immunogenicity of different formulations of GSK Biologicals H7N1 influenza vaccine in subjects 21 to 64 years of age. The study will evaluate safety related events and antibody immune responses to different formulations of study vaccine and placebo.

Conditions studied

Influenza

Browse trials for

Influenza, Human 2,214

Keywords

Immunogenicity
H7N1
Influenza
Safety
AS03 adjuvant
Adults

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's enrollment of 427 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 21 Years to 64 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Male or female adults who are 21 to 64 years of age (inclusive) 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.
Healthy subjects as established by medical history and physical examination.
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.
For subjects who undergo a screening visit, results of all safety laboratory tests obtained at the screening visit must be within reference ranges. Results of any repeat testing cannot be used to qualify a subject for enrollment.
Female subjects of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as current tubal ligation, hysterectomy, ovariectomy or post-menopause.
Female subjects of childbearing potential may be enrolled in the study, if they
- have practiced adequate contraception for 30 days prior to vaccination, and
- have a negative pregnancy test on the day of vaccination, and
- agree to continue to practice adequate contraception until 2 months after the last dose administered.

Exclusion criteria

Exclusion Criteria:

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.
1. Persons with a history of cancer who are disease-free without treatment for three years or more are eligible.
2. 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.
3. Women who are disease-free three years or more after treatment for breast cancer and receiving long-term prophylaxis are eligible.
Diagnosed with excessive daytime sleepiness (unintended sleep episodes during the day present almost daily for at least one month), or narcolepsy.
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.

NOTE: The subject may be vaccinated at a later date, provided symptoms have resolved, and all other eligibility criteria continue to be satisfied.

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.
Known pregnancy or a positive urine beta-human chorionic gonadotropin (β-hCG) test result before the first dose of study vaccine/placebo.
Lactating or nursing women.
Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.

Study design

Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 427 participants (actual)

Study arms

Experimental
Formulation 1 Group
Subjects in this group will receive two doses of GSK2789869A H7N1 vaccine formulation 1 at a 21 day interval
Biological: Investigational H7N1 vaccine GSK2789869A
Experimental
Formulation 2 Group
Subjects in this group will receive two doses of GSK2789869A H7N1 vaccine formulation 2 at a 21 day interval
Biological: Investigational H7N1 vaccine GSK2789869A
Experimental
Formulation 3 Group
Subjects in this group will receive two doses of GSK2789869A H7N1 vaccine formulation 3 at a 21 day interval
Biological: Investigational H7N1 vaccine GSK2789869A
Experimental
Formulation 4 Group
Subjects in this group will receive two doses of GSK2789869A H7N1 vaccine formulation 4 at a 21 day interval
Biological: Investigational H7N1 vaccine GSK2789869A
Experimental
Formulation 5 Group
Subjects in this group will receive two doses of GSK2789868A H7N1 vaccine formulation 5 at a 21 day interval
Biological: Investigational H7N1 vaccine GSK2789868A
Placebo comparator
Placebo Group
Subjects in this group will receive two doses of placebo at a 21 day interval
Biological: Placebo

Interventions

BiologicalInvestigational H7N1 vaccine GSK2789869A
One dose of GSK2789869A H7N1 vaccine administered intramuscularly at the deltoid region of the non-dominant arm at Day 0 while second dose of GSK2789869A H7N1 vaccine administered intramuscularly at the deltoid region of the dominant arm at Day 21
BiologicalInvestigational H7N1 vaccine GSK2789868A
One dose of GSK2789868A H7N1 vaccine administered intramuscularly at the deltoid region of the non-dominant arm at Day 0 while the second dose of GSK2789868A H7N1 vaccine administered intramuscularly at the deltoid region of the dominant arm at Day 21
BiologicalPlacebo
One dose of placebo administered intramuscularly at the deltoid region of the non-dominant arm at Day 0 while the second dose of placebo administered intramuscularly at the deltoid region of the dominant arm at Day 21

What researchers measure

Primary outcomes

Humoral immune response in terms of vaccine-homologous hemagglutination inhibition (HI) antibody titers for each adjuvanted H7N1 vaccine group
The following aggregate variables will be calculated: Seroconversion rates (SCR); Seroprotection rates (SPR); Mean Geometric Increase (MGI);
Time frame: At Day 42
Occurrence of each solicited local symptom
Time frame: During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccination
Occurrence of each solicited general symptom
Time frame: During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccination
Occurrence of clinical safety laboratory abnormalities reported for samples
Time frame: From Day 0 - 42 after each vaccination (i.e Days 0, 7 , 21, 28, 42)
Occurrence of unsolicited adverse events
Time frame: 21 days after each dose
Occurrence of Medically Attended Adverse Events (MAEs), potential Immune Mediated Diseases (pIMDs) and Serious Adverse Events (SAEs)
Time frame: From Day 0 until the Day 42 visit

Secondary outcomes

Humoral immune response in terms of Geometric mean reciprocal serum HI antibody titers (GMTs ratios)
GMT ratios will be calculated for each adjuvanted (GSK2789869A) vaccine group which successfully meets Center for Biologics Evaluation and Research (CBER) and Committee for Medicinal Products for Human Use (CHMP) criteria, and for the unadjuvanted (GSK2789868A) plain antigen vaccine group
Time frame: At Day 42
Humoral immune response in terms of vaccine-homologous HI antibody titers for the unadjuvanted (GSK2789868A) plain antigen vaccine group
The following aggregate variables will be calculated : • SCR; • SPR; • MGI;
Time frame: At Day 42
Vaccine-homologous (H7N1) HI antibody titers
The following aggregate variables will be calculated for each study group: • GMTs; • Seropositivity rates; • SCR; • SPR; • MGI;
Time frame: • GMTs and Seropositivity rates at Days 0, 21, 42 and Months 6 and 12. • SCR and MGI at Day 21, 42 (Placebo group only) and Months 6 and 12. • SPR at Days 0, 21, 42 (Placebo group only) and Months 6 and 12.
Vaccine-homologous (H7N1) HI antibody titers by age stratum
The following aggregate variables will be calculated for each study group by age stratum (21-40 years; 41-64 years): • GMTs; • Seropositivity rates; • SCR; • SPR; • MGI;
Time frame: • GMTs, Seropositivity rates and SPR at Days 0, 21, 42 and Months 6 and 12. • SCR and MGI at Day 21, 42 and Months 6 and 12.
Vaccine-heterologous (H7N9) HI antibody titers
Time frame: • GMTs and Seropositivity rates and SPR at Days 0, 21, 42 and Months 6 and 12. • SCR and MGI at Day 21, 42 and Months 6 and 12.
Vaccine homologous (H7N1) and heterologous (H7N9) neutralizing (MN) antibody titers
Time frame: • GMTs and Seropositivity rates at Days 0, 21, 42 and Month 6. • VRR at Days 21, 42 and Month 6.
Occurrence of MAEs, pIMDs and SAEs
Time frame: After the Day 42 visit until the Month 12 visit
Humoral immune response in terms of SCR difference
SCR difference will be calculated for each adjuvanted (GSK2789869A) vaccine group which successfully meets CBER and CHMP criteria, and for the unadjuvanted (GSK2789868A) plain antigen vaccine group
Time frame: At Day 42

Study locations

9 sites

GSK Investigational Site
Miami, Florida 33143, United States
GSK Investigational Site
Stockbridge, Georgia 30281, United States
GSK Investigational Site
Las Vegas, Nevada 89104, United States
GSK Investigational Site
Rochester, New York 14609, United States
GSK Investigational Site
Cleveland, Ohio 44122, United States
GSK Investigational Site
Austin, Texas 78705, United States
GSK Investigational Site
Truro, Nova Scotia B2N 1L2, Canada
GSK Investigational Site
Sudbury, Ontario P3E 1H5, Canada
GSK Investigational Site
Toronto, Ontario M9W 4L6, Canada

References and documents

Publications

Madan A, Ferguson M, Sheldon E, Segall N, Chu L, Toma A, Rheault P, Friel D, Soni J, Li P, Innis BL, Schuind A. Immunogenicity and safety of an AS03-adjuvanted H7N1 vaccine in healthy adults: A phase I/II, observer-blind, randomized, controlled trial. Vaccine. 2017 Mar 7;35(10):1431-1439. doi: 10.1016/j.vaccine.2017.01.054. Epub 2017 Feb 7. PubMed 28187952 ↗

Individual participant data

Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 8, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01934127
Lead sponsor: GlaxoSmithKline
Responsible party: Sponsor
First posted: Sep 4, 2013
Start date: Aug 26, 2013
Primary completion: Nov 1, 2013
Completion: Oct 20, 2014
Last update: May 8, 2017

Study contacts

GSK Clinical Trials

study director · GlaxoSmithKline

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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