Last updated: 11/07/2018 10:22:55

Study to evaluate the safety and immunogenicity of GlaxoSmithKline (GSK) Biologicals’ influenza vaccines GSK2654911A and GSK2654909A administered to adults 18 to 64 years of age

GSK study ID
116358
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
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 vaccines GSK2654911A and GSK2654909A administered to adults 18 to 64 years of age
Trial description: The purpose of this study is to evaluate the safety, reactogenicity, and immunogenicity of different formulations of a two-dose primary series and booster vaccination of monovalent Influenza H9N2 vaccine manufactured in Quebec, Canada with and without adjuvant, in adults 18 to 64 years of age.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Humoral immune response in terms of HI antibodies against H9N2 v-like antigen

Timeframe: Day 21

Humoral immune response in terms of HI antibodies against H9N2 v-like antigen

Timeframe: Day 42

Secondary outcomes:

Humoral immune response in terms of HI antibodies against H9N2 antigen

Timeframe: GMTs and seropositivity rates, SPR on Days 0, 7, 21, 28, 42, 182, 191, 385 and 546. SCR and MGI on Days 7, 21, 28, 42, 182, 191, 385 and 546. B-SCR and BF on Days 191, 385 and 546.

Humoral immune response in terms of HI antibodies against H9N2 antigen for each vaccine group and for age strata (18-40 years; 41-64 years)

Timeframe: GMTs and seropositivity rates, SPR on Days 0, 7, 21, 28, 42, 182, 191, 385 and 546. SCR and MGI on Days 7, 21, 28, 42, 182, 191, 385 and 546. B-SCR and BF on Days 191, 385 and 546.

Humoral immune response in terms of HI antibodies against any drift strain from H9N2 antigen or against any other H9 subtype antigen

Timeframe: GMTs and seropositivity rates on Days 0, 7, 21, 28, 42, 182 , 191, 385 and 546. SCR and MGI on Days 21, 42, 182, 191, 385, 546. SPR on Days 0, 21, 42, 182, 191, 385 and 546. B-SCR and BF on Days 191, 385 and 546.

Humoral immune response in terms of neutralizing (MN) antibodies against H9N2 and against any drift strain (or other H9 subtype)

Timeframe: GMTs and seropositivity rate on Days 0, 21, 42, 182, 191, 385 and 546. VRR on Days 21, 42, 182, 191, 385, 546. Booster-VRR on Day 191, 385 and 546.

Occurrence of local and general symptoms

Timeframe: During the 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after any vaccination

Occurrence and relationship to vaccination of unsolicited adverse events

Timeframe: Within 21 days (Day 0 to Day 20, 21 to 41, 182 to 202) after any vaccination

Occurrence and relationship to vaccination of adverse events with medically attended visits

Timeframe: During the entire study period (Day 0 – Day 546)

Occurrence and relationship to vaccination of Adverse events of special interest (AESIs), potential Immune-Mediated Diseases (pIMDs), Serious Adverse Events (SAEs) and adverse pregnancy outcome

Timeframe: During the entire study period (Day 0 – Day 546)

Number of subjects with clinical safety laboratory abnormalities

Timeframe: Days 0, 7, 21, 28, 42, 182, 191, and 385.

Interventions:
  • Biological/vaccine: Investigational H9N2 vaccine GSK2654911A
  • Biological/vaccine: Investigational H9N2 vaccine GSK2654909A
  • Biological/vaccine: Placebo
  • Enrollment:
    422
    Primary completion date:
    2012-26-10
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Madan A et al. (2017) Evaluation of a primary course of H9N2 vaccine with or without AS03 adjuvant in adults: A phase I/II randomized trial. Vaccine. pii: S0264-410X(17)30909-X. doi: 10.1016/j.vaccine.2017.07.013.
    Medical condition
    Influenza
    Product
    GSK2654911A
    Collaborators
    Not applicable
    Study date(s)
    August 2012 to March 2014
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 64 years
    Accepts healthy volunteers
    Yes
    • Male or female adults from 18 to 64 years of age (inclusive) at time of first study vaccination.
    • Written informed consent obtained from the 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
    Austin, Texas, United States, 78705
    Status
    Study Complete
    Location
    GSK Investigational Site
    Edison, New Jersey, United States, 08817
    Status
    Study Complete
    Location
    GSK Investigational Site
    Sherbrooke, Québec, Canada, J1H 2G2
    Status
    Study Complete
    Location
    GSK Investigational Site
    Miami, Florida, United States, 33143
    Status
    Study Complete

    Study documents

    Scientific result summary
    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
    Study complete
    Actual primary completion date
    2012-26-10
    Actual study completion date
    2014-19-03

    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 116358 can be found on the GSK Clinical Study Register
    Click here
    Access to clinical trial data by researchers
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