Last updated: 11/07/2018 03:41:35

Primary Vaccination Study with a Pneumococcal Conjugate Vaccine in Healthy Children 6-12wks of Age

GSK study ID
111654
Clinicaltrials.gov ID
EudraCT ID
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: Non-inferiority of a commercial lot of the pneumococcal vaccine GSK1024850A compared to a clinical lot.
Trial description: The purpose of the present study is to demonstrate that the changes in the manufacturing process for the commercial lot of the pneumococcal conjugate vaccine GSK1024850A have no clinical impact and that the immune responses are non-inferior to the immune responses induced by the clinical lot. The study will be conducted in Singapore and Malaysia.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Double (Care Provider, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Concentrations of antibodies against vaccine components of the pneumococcal vaccine

Timeframe: One month after primary immunization (month 4)

Concentration of antibody against protein D (PD)

Timeframe: One month after primary immunization (month 4)

Secondary outcomes:

Number of subjects with anti-pneumococcal vaccine serotype antibody concentrations equal to or above 0.20 µg/mL

Timeframe: One month after primary immunization (month 4)

Number of subjects with anti-pneumococcal cross-reactive serotype concentrations equal to or above 0.20 µg/mL

Timeframe: One month after primary immunization (month 4)

Number of subjects with opsonophagocytic activity against vaccine pneumococcal serotypes

Timeframe: One month after primary immunization (month 4)

Number of subjects with opsonophagocytic activity against cross-reactive pneumococcal serotypes

Timeframe: One month after primary immunization (month 4)

Opsonophagocytic titers of cross-reactive pneumococcal serotypes

Timeframe: One month after primary immunization (month 4)

Poliovirus types 1, 2 and 3 titers

Timeframe: One month after primary immunization (month 4)

Concentrations of antibodies against diphteria toxoid (DT) and tetanus toxoid (TT)

Timeframe: One month after primary immunization (month 4)

Concentration of antibody against hepatitis B surface antigen (HBs) by Enzyme Linked ImmunoSorbent Assay (ELISA).

Timeframe: One month after primary immunization (month 4)

Concentration of antibody against rotavirus immunoglobulin A (IgA)

Timeframe: 3 months after primary immunization (month 4)

Occurrence of serious adverse events

Timeframe: Following vaccination and throughout the entire study period (Month 0 to Month 4)

Opsonophagocytic titers of vaccine pneumococcal serotypes

Timeframe: One month after primary immunization (month 4)

Number of subjects with solicited local and general symptoms.

Timeframe: Within 4 days (day 0-3) after vaccination

Concentrations of antibodies against pertussis toxoid (PT), filamentous haemagglutinin (FHA), pertactin (PRN)

Timeframe: One month after primary immunization (month 4)

Concentration of antibody against polyribosyl-ribitol phosphate (PRP)

Timeframe: One month after primary immunization (month 4)

Occurrence of unsolicited adverse events

Timeframe: Within 31 days (day 0-30) after vaccination

Interventions:
  • Biological/vaccine: Pneumococcal conjugate vaccine GSK1024850A (different lots)
  • Biological/vaccine: Infanrix hexa
  • Biological/vaccine: Infanrix-IPV/Hib
  • Biological/vaccine: Rotarix
  • Enrollment:
    466
    Primary completion date:
    2009-02-11
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Lim FS et al. (2014) A randomised trial to evaluate the immunogenicity, reactogenicity and safety of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) co-administered with routine childhood vaccines in Singapore and Malaysia. BMC Infect Dis.14(1):530.
    Medical condition
    Infections, Streptococcal
    Product
    GSK1024850A, SB208108, SB213503, SB217744, SB444563
    Collaborators
    Not applicable
    Study date(s)
    January 2009 to November 2009
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    6 - 12 weeks
    Accepts healthy volunteers
    Yes
    • Male or female subjects between, and including 6-12 weeks of age at the time of the first vaccination.
    • Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol.
    • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of the study vaccines, or planned use during the study period.
    • Concurrently participating in another clinical study, at any time during the study period.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Kuala Lumpur, Malaysia, 59100
    Status
    Study Complete
    Location
    GSK Investigational Site
    Seremban, Negeri Sembilan, Malaysia, 70300
    Status
    Study Complete
    Location
    GSK Investigational Site
    Singapore, Singapore, 149547
    Status
    Study Complete
    Location
    GSK Investigational Site
    Singapore, Singapore, 119074
    Status
    Study Complete
    Location
    GSK Investigational Site
    Singapore, Singapore, 229899
    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
    2009-02-11
    Actual study completion date
    2009-02-11

    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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