Last updated: 11/07/2018 05:50:34

Immunological persistence after priming with GSK1024850A vaccine and safety& immunogenicity after booster dose

GSK study ID
113266
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: Evaluation of immunological persistence following 3-dose priming with GSK Biologicals’ 10-valent pneumococcal conjugate vaccine in study NCT00808444 and safety and immunogenicity following a booster dose of the same vaccine
Trial description: This primary purpose of this study is the evaluation of the immunological persistence following completion of the 3-dose primary vaccination course with either a clinical or a commercial lot of pneumococcal conjugate vaccine GSK1024850A in study NCT00808444. In addition, the study will also assess the safety, reactogenicity and immunogenicity of a fourth dose of pneumococcal conjugate vaccine GSK1024850A (commercial lot) when co-administered with Infanrix-IPV/Hib at 18-21 months of age in children primed in study NCT00808444.
The primary vaccination study was conducted in Malaysia and Singapore. The booster vaccination study will not be performed in Malaysia since the pneumococcal conjugate vaccine GSK1024850A has been registered in September 2009. However, subjects in Malaysia will be offered a booster dose of the commercial pneumococcal conjugate vaccine licensed in Malaysia and Infanrix-IPV/Hib vaccine during the second year of life according to the nationally recommended regimen. Administration of the booster dose will be outside the set-up of a clinical trial. Hence no data will be collected, no blood samples will be taken in Malaysia.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Concentrations of antibodies against vaccine pneumococcal serotypes.

Timeframe: Before booster vaccination at Month 0

Concentrations of antibodies against protein D (PD).

Timeframe: Before booster vaccination at Month 0

Secondary outcomes:

Number of subjects reporting any and grade 3 solicited local adverse events (AEs).

Timeframe: Within 4 days (Days 0-3) after booster vaccination.

Number of subjects reporting any, grade 3 and related solicited general adverse events (AEs).

Timeframe: Within 4 days (Days 0-3) after booster vaccination.

Number of subjects reporting unsolicited adverse events (AEs).

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

Number of subjects reporting serious adverse events (SAEs).

Timeframe: During the entire study period, from the booster vaccination, at Month 0, up to the study end, at Month 1

Opsonophagocytic activity against vaccine pneumococcal serotypes.

Timeframe: Before and one month after booster vaccination (at Month 0 and Month 1)

Opsonophagocytic activity against cross-reactive pneumococcal serotypes 6A and 19A.

Timeframe: Before and one month after booster vaccination (at Month 0 and Month 1)

Concentrations of antibodies against cross-reactive pneumococcal serotypes.

Timeframe: Before booster vaccination at Month 0

Concentrations of antibodies against diphtheria and tetanus.

Timeframe: Before booster vaccination at Month 0

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

Timeframe: Before booster vaccination at Month 0

Concentrations of antibodies against polyribosyl-ribitol phosphate (PRP).

Timeframe: Before booster vaccination at Month 0

Titers of antibodies against poliovirus types 1, 2 and 3.

Timeframe: Before booster vaccination at Month 0

Concentrations of antibodies against vaccine pneumococcal serotypes.

Timeframe: Before and one month after booster vaccination (at Month 0 and Month 1)

Concentrations of antibodies against cross-reactive pneumococcal serotypes.

Timeframe: Before and one month after booster vaccination (at Month 0 and Month 1)

Concentrations of antibodies against protein D (PD).

Timeframe: Before and one month after booster vaccination (at Month 0 and Month 1)

Concentrations of antibodies against diphtheria and tetanus.

Timeframe: Before and one month after booster vaccination (at Month 0 and Month 1)

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

Timeframe: Before and one month after booster vaccination (at Month 0 and Month 1)

Concentrations of antibodies against polyribosyl-ribitol phosphate (PRP).

Timeframe: Before and one month after booster vaccination (at Month 0 and Month 1)

Titers of antibodies against poliovirus types 1, 2 and 3.

Timeframe: Before and one month after booster vaccination (at Month 0 and Month 1)

Interventions:
  • Biological/vaccine: Pneumococcal vaccine GSK1024850A
  • Biological/vaccine: Infanrix-IPV/Hib
  • Enrollment:
    238
    Primary completion date:
    2011-17-02
    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
    Collaborators
    Not applicable
    Study date(s)
    July 2010 to February 2011
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 21 months
    Accepts healthy volunteers
    Yes
    • Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol
    • Male or female between, and including, 18 and 21 months of age at the time of booster vaccination.
    • Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding vaccination, or planned use during the study period.
    • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Singapore, Singapore, 119074
    Status
    Study Complete
    Location
    GSK Investigational Site
    Singapore, Singapore, 229899
    Status
    Study Complete
    Location
    GSK Investigational Site
    Singapore, Singapore, 688846
    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
    2011-17-02
    Actual study completion date
    2011-17-02

    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
    Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
    Click here
    Access to clinical trial data by researchers
    Visit website