Last updated: 03/25/2020 12:10:18

Assess consistency of immunogenicity of GlaxoSmithKline Biologicals' pandemic influenza vaccine (GSK1562902A) in adults

GSK study ID
109630
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: Assess the consistency of the immunogenicity of a GlaxoSmithKline Biologicals' pandemic influenza vaccine (GSK1562902A) in adults aged between 18 and 60 years
Trial description: The present study is designed to assess the lot-to-lot consistency of the immunogenicity of a GlaxoSmithKline Biologicals' pandemic influenza candidate vaccine (GSK1562902A) in adults aged between 18 and 60 years.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Titers for serum Hemagglutination Inhibition (HI) antibodies against 2 strains of influenza disease

Timeframe: Before vaccination (Day 0)

Titers for serum Hemagglutination Inhibition (HI) antibodies against 2 strains of influenza disease

Timeframe: Within 21 days following 2-dose primary vaccination (at Day 42)

Secondary outcomes:

Titers for serum Hemagglutination Inhibition (HI) antibodies against 2 strains of influenza disease

Timeframe: Within 21 days following the first primary vaccination dose (Day 21)

Titers for serum Hemagglutination Inhibition (HI) antibodies against 2 strains of influenza disease

Timeframe: Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D) and at Month 6+42 days (M6+42D)

Titers for serum Hemagglutination Inhibition (HI) antibodies against 2 strains of influenza disease

Timeframe: Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D) and at Month 6+42 days (M6+42D) and at Month 12 (M12)

Titers for serum neutralizing (SN) antibodies against 2 strains of influenza disease

Timeframe: Before vaccination at Day 0 (D0) and within 21 days following 2-dose primary vaccination at Day 42 (D42)

Titers for serum neutralization (SN) antibodies against 2 strains of influenza disease

Timeframe: Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D) and at Month 6+42 days (M6+42D)

Titers for serum Hemagglutination Inhibition (HI) antibodies against 2 strains of influenza disease in adults who had not received the booster dose at Month 6

Timeframe: At Day 0, at Day 21, at Day 42, at Month 6 and at Month 12

Titers for serum neutralization (SN) antibodies against 2 strains of influenza disease in adults who had not received the booster dose at Month 6

Timeframe: At Month 12

Number of seroconverted subjects for HI antibodies against 2 strains of influenza disease

Timeframe: At Day 21 (D21) and at Day 42 (D42)

Number of seroconverted subjects for HI antibodies against 2 strains of influenza disease

Timeframe: Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D) and at Month 6+42 days (M6+42D)

Number of seroconverted subjects for HI antibodies against 2 strains of influenza disease for adults who received the booster dose at Month 6 - Booster Phase

Timeframe: Following booster vaccination at Month 6 +21 days (M6+21D) and Month 6 +42 days (M6+42D)

Number of seroconverted subjects for HI antibodies against 2 strains of influenza disease for adults who received the booster dose at Month 6 - Booster Phase

Timeframe: At Month 12

Number of seroconverted subjects for neutralizing antibodies against 2 strains of influenza disease

Timeframe: Within 21 days following 2-dose primary vaccination at Day 42

Number of seroconverted subjects for neutralizing antibodies against 2 strains of influenza disease - Booster Phase

Timeframe: Following booster vaccination at Month 6+21 days (M6+21D) and at Month 6+42 days (M6+42D)

Number of seroconverted subjects for HI antibodies against 2 strains of influenza disease for adults who have not received booster at Month 6

Timeframe: At Day 21, Day 42, Month 6 and Month 12 following primary vaccination

Number of seroconverted subjects for neutralizing antibodies against 2 strains of influenza disease for subjects not boosted at Month 6

Timeframe: At Month 12

Seroconversion factor for Hemagglutination Inhibition (HI) antibodies against 2 strains of influenza disease

Timeframe: At day 21 and Day 42

Seroconversion factor for Hemagglutination Inhibition (HI) antibodies against 2 strains of influenza disease

Timeframe: Before booster vaccination at Month 6 (M6) and within 21 days following each booster dose: At Month 6 + 21 days (M6+21D) and, for H5N1 Un-adjuvanted Group only, at Month 6 + 42 days (M6+42D)

Booster seroconversion factor for Hemagglutination Inhibition (HI) antibodies against 2 strains of influenza disease

Timeframe: Within 21 days following each booster dose: At Month 6 + 21 days (M6+21D) and, for H5N1 Un-adjuvanted Group only, at Month 6 + 42 days (M6+42D)

Booster seroconversion factor for Hemagglutination Inhibition (HI) antibodies against 2 strains of influenza disease

Timeframe: At Month 12

Seroconversion factor for Hemagglutination Inhibition (HI) antibodies against 2 strains of influenza disease for subjects not boosted at Month 6

Timeframe: At Day 21, at Day 42, at Month 6 and at Month 12

Number of subjects seroprotected against 2 strains of influenza disease

Timeframe: Before primary vaccination at Day 0 and within 21 days following each primary vaccination dose at Day 21 and at Day 42.

Number of subjects seroprotected against 2 strains of influenza disease

Timeframe: Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D) and at Month 6+42 days (M6+42D)

Number of seroprotected subjects against 2 strains of influenza disease

Timeframe: Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D), at Month 6+42 days (M6+42D) and at Month 12 (M12)

Number of subjects seroprotected against 2 strains of influenza disease for subjects not boosted at Month 6

Timeframe: At Day 0, Day 21, Day 42, Month 6 and Month 12

Frequency of influenza-specific Cluster of Differentiation 4+ (CD4+) T cells expressing at least 2 markers among the analyzed cytokines upon in vitro stimulation

Timeframe: Within 21 days of each primary vaccine dose: at Day 21 and at Day 42

Frequency of influenza-specific Cluster of Differentiation 8+ (CD8+) T cells expressing at least 2 markers among the analyzed cytokines upon in vitro stimulation

Timeframe: Within 21 days of each primary vaccine dose: at Day 21 and at Day 42

Frequency of influenza-specific Cluster of Differentiation 4+ (CD4+) T cells expressing at least 2 markers among the analyzed cytokines upon in vitro stimulation

Timeframe: Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D), at Month 6+42 days (M6+42D) and at Month 12 (M12)

Frequency of influenza-specific Cluster of Differentiation 8+ (CD8+) T cells expressing at least 2 markers among the analyzed cytokines upon in vitro stimulation

Timeframe: Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D), at Month 6+42 days (M6+42D) and at Month 12 (M12)

Frequency of influenza-specific Cluster of Differentiation 4+ (CD4+) T cells expressing at least 2 markers among the analyzed cytokines upon in vitro stimulation for subjects not boosted at Month 6

Timeframe: At Month 6 and Month 12

Frequency of influenza-specific Cluster of Differentiation 8+ (CD8+) T cells expressing at least 2 markers among the analyzed cytokines upon in vitro stimulation for subjects not boosted at Month 6

Timeframe: At Month 6 and at Month 12

Number of subjects with any and Grade 3 solicited local symptoms

Timeframe: During the 7-days (Days 0-6) post-primary vaccination period following each dose and overall

Number of subjects with any, Grade 3 and related solicited general symptoms

Timeframe: During the 7-days (Days 0-6) post-primary vaccination period following each dose and overall

Number of subjects with any and Grade 3 solicited local symptoms - Booster Phase

Timeframe: During the 7-days (Days 0-6) post-booster vaccination period

Number of subjects with any, Grade 3 and related solicited general symptoms - Booster Phase

Timeframe: During the 7-days (Days 0-6) post-booster vaccination period

Number of subjects with any unsolicited adverse events (AEs)

Timeframe: During the primary phase (from Day 0 to Month 6)

Number of subjects with any unsolicited adverse events (AEs)

Timeframe: During the booster phase (from Month 6 to Month 12)

Number of subjects with serious adverse events (SAEs).

Timeframe: During the primary phase (from Day 0 to Month 6)

Number of subjects with serious adverse events (SAEs).

Timeframe: During the booster phase (from Month 6 to Month 12)

Number of subjects with serious adverse events (SAEs) for subjects not boosted at Month 6

Timeframe: From Month 6 to Month 12

Interventions:
  • Biological/vaccine: H5N1 adjuvanted split virus vaccine (A/Vietnam/1194/2004 strain)
  • Biological/vaccine: H5N1 non-adjuvanted split virus vaccine (A/Vietnam/1194/2004 strain)
  • Biological/vaccine: H5N1 adjuvanted split virus vaccine (A/Indonesia/05/2005 strain)
  • Enrollment:
    1206
    Primary completion date:
    2007-12-07
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Chu DW et al. (2009) Immunogenicity and tolerability of an AS03(A)-adjuvanted prepandemic influenza vaccine: A phase III study in a large population of Asian adults. Vaccine. 27(52):7428-7435.
    Chu DW et al. (2011) Cross-clade immunogenicity and safety of an AS03A-adjuvanted prepandemic H5N1 influenza vaccine in Hong Kong. Hong Kong Med J. 17(1):39-46.
    Hwang SJ et al. (2011) Immunogenicity and safety of an AS03(A)-adjuvanted H5N1 influenza vaccine in a Taiwanese population. J Formos Med Assoc. 110(12):780-786.
    Thongcharoen P et al. (2011) Cross-clade immunogenicity and antigen-sparing with an AS03A-adjuvanted prepandemic influenza vaccine in a Thai population. J Med Assoc Thai. 94(8):916-926.
    Gillard P et al. (2014) Long-term booster schedules with AS03A-adjuvanted heterologous H5N1 vaccines induces rapid and broad immune responses in Asian adults. BMC Infect Dis. 14:142.
    Thongcharoen P et al. (2011) Cross-clade immunogenicity and antigen-sparing with an AS03(A)-adjuvanted prepandemic influenza vaccine in a Thai population. J Med Assoc Thai; 94(8):916-926.
    Medical condition
    Influenza
    Product
    GSK1562902A
    Collaborators
    Not applicable
    Study date(s)
    March 2007 to June 2008
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 60 years
    Accepts healthy volunteers
    Yes
    • Subjects who the investigator believes that they can and will comply with the requirements of the protocol
    • A male or female between, and including, 18 and 60 years of age at the time of the first vaccination.
    • Administration of any licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study.
    • Planned administration of a vaccine not foreseen by the study protocol during the following periods: from Day 0 up to Day 51, 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to Month 6; from Month 6 up to Month 6 + 30 days (or Month 6 + 51 days for the control groups).

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Bangkok, Thailand, 10700
    Status
    Study Complete
    Location
    GSK Investigational Site
    Hong Kong, Hong Kong
    Status
    Study Complete
    Location
    GSK Investigational Site
    Singapore, Singapore, 529889
    Status
    Study Complete
    Location
    GSK Investigational Site
    Singapore, Singapore, 688846
    Status
    Study Complete
    Location
    GSK Investigational Site
    Taipei, Taiwan, 100
    Status
    Study Complete
    Location
    GSK Investigational Site
    Taipei, Taiwan, 112
    Status
    Study Complete

    Study documents

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

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

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2007-12-07
    Actual study completion date
    2008-10-06

    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

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