Last updated: 07/17/2024 15:25:17

Evaluation of a booster dose of pneumococcal vaccine formulations in young adults

GSK study ID
112993
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: A study to evaluate safety and immunogenicity of a booster dose of two formulations of GSK Biologicals’ pneumococcal candidate vaccine in healthy young adults
Trial description: The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of a booster dose of pneumococcal vaccines (GSK 2189242A) in young adults.
This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT 00707798)
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Number of subjects with Grade 3 solicited local symptoms

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

Number of subjects with Grade 3 and vaccine-related solicited general symptoms

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

Number of subjects with Grade 3 and vaccine-related unsolicited adverse events (AEs)

Timeframe: During the 31-day (Days 0-30) post-booster vaccination period

Number of subjects with any vaccine-related serious adverse events (SAEs)

Timeframe: During the entire study period (from Day 0 to Day 30)

Number of subjects with Grade 3 haematological or biochemical abnormalities

Timeframe: At Days 1 and 6 post-booster vaccination

Secondary outcomes:

Antibody concentrations against pneumococcal pneumolysin toxoid (dPly) and histidine triad protein D (PhtD) proteins

Timeframe: Prior to the booster vaccination (Day 0) and one month post-booster vaccination (Day 30)

Titers for antibodies against pneumolysin haemolysis (Hem-dPly) protein

Timeframe: Prior to the booster vaccination (Day 0) and one month post-booster vaccination (Day 30)

Number of subjects with any solicited local symptoms

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

Number of subjects with any solicited general symptoms

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

Number of subjects with any unsolicited AEs

Timeframe: During the 31-day (Days 0-30) post-booster vaccination period

Number of subjects with any SAEs

Timeframe: During the entire study period (from Day 0 to Day 30)

Number of subjects with Grade 1, Grade 2 and Grade 4 haematological or biochemical abnormalities

Timeframe: At 1 and 6 days post-booster vaccination

Interventions:
  • Biological/vaccine: Pneumococcal vaccine GSK2189242A (formulation 1)
  • Biological/vaccine: Pneumococcal vaccine GSK2189242A (formulation 2)
  • Enrollment:
    43
    Primary completion date:
    2009-05-08
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Leroux-Roels G et al. (2014) Safety, reactogenicity and immunogenicity of a novel pneumococcal protein-based vaccine in adults: a phase I/II randomized clinical study. Vaccine. 32(50):6838-6846.
    Medical condition
    Infections, Streptococcal
    Product
    GSK2189242A
    Collaborators
    Not applicable
    Study date(s)
    May 2009 to August 2009
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 41 years
    Accepts healthy volunteers
    Yes
    • Subjects who the investigator believes will comply with the requirements of the protocol should be enrolled in the study.
    • A male or female between, and including, 18 and 41 years old at the time of vaccination.
    • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the vaccination, 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 vaccination.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Gent, Belgium, 9000
    Status
    Study Complete

    Study documents

    Scientific result summary
    Available language(s): English
    Clinical study report
    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
    2009-05-08
    Actual study completion date
    2009-05-08

    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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    Additional information
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