Last updated: 11/07/2018 01:33:45

Assess immunogenicity, reactogenicity, safety of a booster of GSK Biologicals DTPw-HBV/Hib Kft compared to DTPw-HBV/Hib

GSK study ID
106602
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: Immunogenicity, Reactogenicity & Safety of a Booster Dose of GSK Biologicals’ DTPw-HBV/Hib Kft Vaccine Vs GSK Biologicals’ DTPw-HBV/Hib Vaccine, in Infants Who Received a 3-Dose Primary Vaccination Course With the Same Vaccines.
Trial description: This booster study will assess the immunogenicity, reactogenicity and safety of a booster dose of GSK Biologicals’ DTPw-HBV/Hib Kft. vaccine versus DTPw-HBV/Hib vaccine, in healthy children, 18 to 24 months of age, who received the same vaccine for primary vaccination. Prior to the booster dose, this study will also assess the persistence of antibodies to the vaccine antigen components administered in the primary vaccination course. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Anti-polyribosyl-ribitol-phosphate (PRP) antibody concentration

Timeframe: One month after the booster dose

Anti-hepatitis B surface antigen (HBs) antibody concentration

Timeframe: One month after the booster dose

Anti-diphtheria antibody concentration

Timeframe: One month after the booster dose

Anti-tetanus antibody concentration

Timeframe: One month after the booster dose

Secondary outcomes:

Anti-Bordetella pertussis (BPT) antibody concentration

Timeframe: One month after the booster dose

Anti-PRP antibody concentration

Timeframe: Prior to the booster dose

Anti-HBs antibody concentration

Timeframe: Prior to the booster dose

Anti-diphtheria antibody concentration

Timeframe: Prior to the booster dose

Anti-tetanus antibody concentration

Timeframe: Prior to the booster dose

Anti-BPT antibody concentration

Timeframe: Prior to the booster dose

Occurrence of solicited symptoms

Timeframe: During the 4-day follow-up period after the booster dose

Occurrence of unsolicited symptoms

Timeframe: During the 31-day follow-up period after the booster dose

Occurrence of serious adverse events

Timeframe: During the entire study period.

Interventions:
  • Biological/vaccine: DTPw-HBV/Hib Kft vaccine GSK323527A
  • Biological/vaccine: Tritanrix™-HepB/Hiberix™
  • Enrollment:
    148
    Primary completion date:
    2006-12-10
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Bravo L et al. (1998) The new DTPw-HBV-Hib combination vaccine can be used at the who schedule with a monovalent dose of hepatitis B vaccine at birth. Southeast Asian J Trop Med Public Health. 29(4):772-778.
    Espinoza F et al. (2010) Primary and booster vaccination in Latin American children with a DTPw-HBV/Hib combination: a randomized controlled trial. BMC Infectious Diseases. 10:297.
    Medical condition
    Hepatitis B, Whole Cell Pertussis, Tetanus, Haemophilus influenzae type b, Diphtheria
    Product
    GSK323527A
    Collaborators
    Not applicable
    Study date(s)
    June 2006 to October 2006
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 24 months
    Accepts healthy volunteers
    Yes
    • Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
    • A male or female toddler, 18 to 24 months of age at the time of booster vaccination, who completed the three-dose primary vaccination course in the 101223 study.
    • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
    • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccine dose.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Leon, Nicaragua
    Status
    Study Complete
    Location
    GSK Investigational Site
    Capital Federal, Buenos Aires, Argentina, 1425
    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

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2006-12-10
    Actual study completion date
    2006-12-10

    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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