Last updated: 06/26/2019 11:10:24

Immunogenicity and safety study of GlaxoSmithKline (GSK) Biologicals’ influenza vaccine(s) GSK3206641A and GSK3206640A administered in adults 18 to 64 years of age

GSK study ID
201072
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: 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
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Humoral immune response in terms of vaccine-homologous hemagglutination inhibition (HI) antibody titers

Timeframe: At Day 42

Occurrence of each solicited local symptom

Timeframe: 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

Timeframe: 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

Timeframe: At Day 0 visit

Occurrence of clinical safety laboratory abnormalities reported for samples

Timeframe: At Day 7 visit

Occurrence of clinical safety laboratory abnormalities reported for samples

Timeframe: At Day 21 visit

Occurrence of clinical safety laboratory abnormalities reported for samples

Timeframe: At Day 28 visit

Occurrence of clinical safety laboratory abnormalities reported for samples

Timeframe: At Day 42 visit

Occurrence of unsolicited adverse events

Timeframe: 21 days after each dose

Occurrence of Medically Attended Adverse Events (MAEs), potential Immune Mediated Diseases (pIMDs) and Serious Adverse Events (SAEs)

Timeframe: From Day 0 until the Day 42

Secondary outcomes:

Humoral immune response in terms of vaccine-homologous hemagglutination inhibition (HI) antibody titers

Timeframe: At Day 42

Humoral immune response in terms of vaccine-homologous hemagglutination inhibition (HI) antibody titers

Timeframe: At Day 42

Humoral immune response in terms of vaccine-homologous (H7N9) HI antibody titers

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: Until the Month 12 visit

Interventions:
Biological/vaccine: Investigational H7N9 vaccine GSK3206641A
Biological/vaccine: Investigational H7N9 vaccine GSK3206640A
Biological/vaccine: Placebo
Enrollment:
424
Observational study model:
Not applicable
Primary completion date:
2014-01-02
Time perspective:
Not applicable
Clinical publications:
Madan A et al. (2016) Immunogenicity and safety of an AS03-adjuvanted H7N9 pandemic influenza vaccine in a randomised trial in healthy adults. J Infect Dis. pii: jiw414. [Epub ahead of print].
Medical condition
Influenza
Product
GSK3206640A, GSK3206641A
Collaborators
Not applicable
Study date(s)
November 2013 to January 2015
Type
Interventional
Phase
1

Participation criteria

Sex
Female & Male
Age
18 - 64 years
Accepts healthy volunteers
Yes
  • 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.
  • 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.

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Boise, Idaho, United States, 83642
Status
Study Complete
Location
GSK Investigational Site
Erie, Pennsylvania, United States, 16506
Status
Study Complete
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32216
Status
Study Complete
Location
GSK Investigational Site
Seattle, Washington, United States, 98105
Status
Study Complete
Location
GSK Investigational Site
Sherbrooke, Québec, Canada, J1H 2G2
Status
Study Complete
Location
GSK Investigational Site
Stockbridge, Georgia, United States, 30281
Status
Study Complete
Location
GSK Investigational Site
Truro, Nova Scotia, Canada, B2N 1L2
Status
Study Complete
Location
GSK Investigational Site
Woodstock, Ontario, Canada, N4S 5P5
Status
Study Complete

Study documents

Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Completed
Actual primary completion date
2014-01-02
Actual study completion date
2015-19-01

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Participate in clinical trial
Additional information
Results for study 201072 can be found on the GSK Clinical Study Register
Click here
Access to clinical trial data by researchers
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