Last updated: 11/03/2018 21:27:48

Immunogenicity and safety study of GlaxoSmithKline (GSK) Biologicals’ influenza vaccine(s) GSK3277510A and GSK3277509A in adults 18 to 60 years of age

GSK study ID
201300
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Withdrawn
Withdrawn
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) GSK3277510A and GSK3277509A administered in adults 18 to 60 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 60 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 the Day 0, 7, 21, 28 and 42 visits.

Occurrence of unsolicited adverse events (AEs)

Timeframe: 21 days after each dose.

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

Timeframe: From Day 0 until Day 42.

Secondary outcomes:

Evaluation of adjuvant effect as assessed by vaccine-homologous hemagglutination inhibition (HI) antibody titers

Timeframe: At Day 42.

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

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 Days 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) neutralizing (MN) antibody titres.

Timeframe: GMTs and Seropositivity rates at the Days 0, 21, 42 and Month 6 visits. VRR at Days 21, 42 and Month 6 visits.

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 Days 21, 42 and Months 6 and 12.

Humoral immune response in terms of vaccine homologous (H7N9) neutralizing (MN) antibody titers for each study group by age stratum (18-40 years; 41-60 years)

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 GSK3277510A
Biological/vaccine: Investigational H7N9 vaccine GSK3277509A
Biological/vaccine: Placebo
Enrollment:
0
Observational study model:
Not applicable
Primary completion date:
2016-04-06
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Influenza
Product
GSK3277510A
Collaborators
Not applicable
Study date(s)
March 2016 to May 2017
Type
Interventional
Phase
1

Participation criteria

Sex
Female & Male
Age
18 - 60 years
Accepts healthy volunteers
Yes
  • Male or female adults who are 18 to 60years 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)

No location data available.

Study documents

No study documents available.

Results overview

Study Results yet to be posted

Recruitment status
Withdrawn
Actual primary completion date
Not applicable
Actual study completion date
Not applicable

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

Additional information
Not applicable
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