Last updated: 11/03/2018 00:28:02

Immune response post pry vaccination of 2 formulations of DTPw-HBV vaccine given with rotavirus vaccine to infants

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GSK study ID
104021
See study documents
Clinicaltrials.gov ID
NCT00158756
See results summary
EudraCT ID
2011-003878-86
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: A phase III, partially blind, randomized study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ Tritanrix™-HepB and GSK Biologicals Kft’s DTPw-HBV vaccines as compared to concomitant administration of Commonwealth Serum Laboratory’s (CSL’s) DTPw (Triple Antigen™) and GSK Biologicals’ HBV (Engerix™-B), when co-administered with GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine, to healthy infants at 3, 4½ and 6 months of age, after a birth dose of hepatitis B vaccine.
Trial description: To compare the two formulations of GSK Biologicals’ DTPw-HBV vaccine to concomitant administration of CSL’s DTPw vaccine and GSK Biologicals’ HBV with respect to the antibody response to the diphtheria antigen after a three-dose primary vaccination course.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Seroprotection status for anti-diphteria (anti-DT) antibodies

Timeframe: At one month post dose 3 [PIII(M4)]

Secondary outcomes:

Number of seroprotected subjects for anti-DT antibodies as assessed by ELISA

Timeframe: At one month post dose 3 [PIII(M4)]

Number of seroprotected subjects for anti-Hepatitis B (anti-HBs) antibodies

Timeframe: At one most post dose 3 [PIII(M4)]

Number of seropositive subjects with Anti-Bordetella Pertussis (anti-BPT) antibody concentrations ≥ the established cut-off values

Timeframe: At one month post dose 3 [PIII(M4)]

Number of subjects with vaccine response to BPT antigen

Timeframe: At one month post dose 3 [PIII(M4)]

Number of seropositive subjects with anti-rotavirus (anti-RV) antibodies above the cut-off values

Timeframe: At 2.5 months after dose 2 of Rotarix [PIII(M4)]

Number of seroprotected subjects for anti-Tetanus (anti-T) antigen

Timeframe: At one month post dose 3 [PIII(M4)]

Number of seroprotected subjects for anti-Poliovirus types 1, 2, 3 (anti-Polio 1, 2, 3)

Timeframe: At one month post dose 3 [PIII(M4)]

Concentrations of anti-HBs antibodies

Timeframe: At one month post dose 3 [PIII(M4)]

Concentrations of anti-DT antibodies

Timeframe: At one month post dose 3 [PIII(M4)]

Concentrations of anti-T antibodies

Timeframe: At one month post dose 3 [PIII(M4)]

Concentrations of anti-BPT antibodies

Timeframe: At one month post dose 3 [PIII(M4)]

Concentrations of anti-RV antibodies

Timeframe: At 2.5 months post dose 2 of Rotarix [PIII(M4)]

Anti-Polio type 1, 2, 3 antibody titers

Timeframe: At one month post dose 3 [PIII(M4)]

Number of subjects with solicited local symptoms

Timeframe: During the 8-Day (Days 0-7) follow-up period

Number of subjects with any solicited general symptoms

Timeframe: During the 8-day period (Days 0-7) post-vaccination

Number of subjects with unsolicited adverse events (AEs)

Timeframe: During the 31-day (Days 0-30) follow-up period

Number of subjects with serious adverse events (SAEs)

Timeframe: From Month 0 to Month 4

Interventions:
  • Biological/vaccine: Tritanrix™-HepB
  • Biological/vaccine: Rotarix™
  • Biological/vaccine: Zilbrix™
  • Biological/vaccine: Triple Antigen™
  • Biological/vaccine: Engerix™-B
  • Drug: Placebo
    • Enrollment:
    308
    Primary completion date:
    2006-23-11
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Hepatitis B
    Product
    GSK196131A
    Collaborators
    Not applicable
    Study date(s)
    September 2005 to November 2006
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    3 weeks - 4 months
    Accepts healthy volunteers
    Yes
    • Inclusion criteria:
    • Subjects who the investigator believes that their parent/guardian can and will comply with the requirements of the protocol.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Subjects who the investigator believes that their parent/guardian can and will comply with the requirements of the protocol.
    • Administration of one dose of hepatitis B vaccine at birth.
    • A male or female between, and including, 11 and 17 weeks of age at the time of the first DTPw vaccination.
    • Free of obvious health problems as established by medical history and clinical examination before entering into the study. Exclusion criteria:
    • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
    • Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
    • Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days before the first vaccine dose or planned administration during the study period with the exception of oral polio vaccine.
    • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required)
    • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Ivanteevka Moscow region, Russia, 141280
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Samara, Russia, 443021
    Status
    Study Complete
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    Location
    GSK Investigational Site
    St Petersburg, Russia, 197022
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Ekaterinburg, Russia, 620003
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Barnaul, Russia, 656049
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Tomsk, Russia, 634 050
    Status
    Study Complete
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    Showing 1 - 6 of 9 Results

    Study documents

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

    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
    2006-23-11
    Actual study completion date
    2006-23-11

    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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