Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Influenza Vaccine(s) GSK3206641A and GSK3206640A Administered in Adults 18 to 64 Years of Age
An Observer-blind Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine(s) GSK3206641A and GSK3206640A Administered in Adults 18 to 64 Years of Age
1 other identifier
interventional
424
2 countries
8
Brief Summary
The purpose of this study is to evaluate the safety and immunogenicity of different formulations of GSK Biologicals' H7N9 influenza vaccine in subjects 18 to 64 years of age.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2013
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2013
CompletedStudy Start
First participant enrolled
November 25, 2013
CompletedFirst Posted
Study publicly available on registry
December 3, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 19, 2015
CompletedMay 30, 2017
May 1, 2017
2 months
November 21, 2013
May 26, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (10)
Humoral immune response in terms of vaccine-homologous hemagglutination inhibition (HI) antibody titers
The following aggregate variables will be calculated for each adjuvanted H7N9 vaccine group: • Seroconversion rates (SCR); • Seroprotection rates (SPR); • Mean Geometric Increase (MGI)
At Day 42
Occurrence of each solicited local symptom
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
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
At Day 0 visit
Occurrence of clinical safety laboratory abnormalities reported for samples
At Day 7 visit
Occurrence of clinical safety laboratory abnormalities reported for samples
At Day 21 visit
Occurrence of clinical safety laboratory abnormalities reported for samples
At Day 28 visit
Occurrence of clinical safety laboratory abnormalities reported for samples
At Day 42 visit
Occurrence of unsolicited adverse events
21 days after each dose
Occurrence of Medically Attended Adverse Events (MAEs), potential Immune Mediated Diseases (pIMDs) and Serious Adverse Events (SAEs)
From Day 0 until the Day 42
Secondary Outcomes (6)
Humoral immune response in terms of vaccine-homologous hemagglutination inhibition (HI) antibody titers
At Day 42
Humoral immune response in terms of vaccine-homologous hemagglutination inhibition (HI) antibody titers
At Day 42
Humoral immune response in terms of vaccine-homologous (H7N9) HI antibody titers
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
Humoral immune response in terms of vaccine-homologous (H7N9) HI antibody titers by age stratum
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
Humoral immune response in terms of vaccine homologous (H7N9) neutralizing (MN) antibody titers
GMTs and Seropositivity rates at Days 0, 21, 42 and Month 6; VRR at Days 21, 42 and Month 6
- +1 more secondary outcomes
Study Arms (6)
Formulation 1 Group
EXPERIMENTALSubjects in this group will receive two doses of GSK3206641A H7N9 vaccine formulation 1 at a 21 day interval
Formulation 2 Group
EXPERIMENTALSubjects in this group will receive two doses of GSK3206641A H7N9 vaccine formulation 2 at a 21 day interval
Formulation 3 Group
EXPERIMENTALSubjects in this group will receive two doses of GSK3206641A H7N9 vaccine formulation 3 at a 21 day interval
Formulation 4 Group
EXPERIMENTALSubjects in this group will receive two doses of GSK3206641A H7N9 vaccine formulation 4 at a 21 day interval
Formulation 5 Group
EXPERIMENTALSubjects in this group will receive two doses of GSK3206640A H7N9 vaccine formulation 5 at a 21 day interval
Placebo Group
PLACEBO COMPARATORSubjects in this group will receive two doses of placebo at a 21 day interval
Interventions
One dose of GSK3206641A H7N9 vaccine administered intramuscularly (IM) in the deltoid region of arm at Day 0 and the second dose of GSK3206641A H7N9 vaccine administered IM in the deltoid region of arm at Day 21
One dose of GSK3206640A H7N9 vaccine administered IM at the deltoid region of arm at Day 0 and the second dose of GSK3206640A H7N9 vaccine administered IM at the deltoid region of arm at Day 21
One dose of placebo administered IM at the deltoid region of arm at Day 0 and the second dose of placebo administered IM at the deltoid region of arm at Day 21
Eligibility Criteria
You may qualify if:
- Male or female adults who are 18 to 64 years of age (inclusive) at the time of first study vaccination.
- Written informed consent obtained from 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.
- 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 enrolment.
- 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.
You may not qualify if:
- 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, or narcolepsy; or history of narcolepsy in a 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.
- Any significant disorder of coagulation or treatment with warfarin derivatives or heparin.
- 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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (8)
GSK Investigational Site
Jacksonville, Florida, 32216, United States
GSK Investigational Site
Stockbridge, Georgia, 30281, United States
GSK Investigational Site
Boise, Idaho, 83642, United States
GSK Investigational Site
Erie, Pennsylvania, 16506, United States
GSK Investigational Site
Seattle, Washington, 98105, United States
GSK Investigational Site
Truro, Nova Scotia, B2N 1L2, Canada
GSK Investigational Site
Woodstock, Ontario, N4S 5P5, Canada
GSK Investigational Site
Sherbrooke, Quebec, J1H 2G2, Canada
Related Publications (1)
Madan A, Segall N, Ferguson M, Frenette L, Kroll R, Friel D, Soni J, Li P, Innis BL, Schuind A. Immunogenicity and Safety of an AS03-Adjuvanted H7N9 Pandemic Influenza Vaccine in a Randomized Trial in Healthy Adults. J Infect Dis. 2016 Dec 1;214(11):1717-1727. doi: 10.1093/infdis/jiw414. Epub 2016 Sep 7.
PMID: 27609809DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 21, 2013
First Posted
December 3, 2013
Study Start
November 25, 2013
Primary Completion
February 1, 2014
Study Completion
January 19, 2015
Last Updated
May 30, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.