Last updated: 07/17/2024 15:14:30

Pneumococcal Vaccine Booster Study in Healthy Children 11-18 Months Old Previously Primed With the Same Vaccines

GSK study ID
109507
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: Booster Vaccination With Pneumococcal Vaccine GSK1024850A, a DTPa-Combined and MenC or Hib-MenC Vaccines
Trial description: The purpose of this study is to assess the safety in terms of fever (rectal temperature) higher than 39 degree Celcius (°C) and the immunogenicity in terms of antibody response following a booster vaccination with pneumococcal vaccine GSK1024850A at 11 to 18 months of age in children previously primed with the same vaccines including a pneumococcal conjugate vaccine co-administered with a diphtheria, tetanus, acellular pertussis (DTPa)-combined and meningococcal serogroup C (MenC) or combined meningococcal serogroup C and Haemophilus influenzae type b (Hib-MenC) vaccine.
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 number = NCT00334334).
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Number of subjects reporting fever above 39.0 degree Celsius (°C)

Timeframe: During the 4-day (Day 0-3) period after the booster vaccination

Secondary outcomes:

Number of subjects reporting solicited local symptoms

Timeframe: During the 4-day (Day 0-3) period after the booster vaccination

Number of subjects reporting solicited general symptoms

Timeframe: During the 4-day (Day 0-3) period after the booster vaccination

Number of subjects reporting unsolicited adverse events (AE)

Timeframe: During the 31-day (Day 0-30) period after the booster vaccination

Number of subjects reporting serious adverse events (SAE)

Timeframe: During the 31-day (Day 0-30) period after the booster vaccination

Number of subjects reporting serious adverse events (SAE)

Timeframe: From the beginning of the study up to the end of the extended 6-month safety follow-up period

Number of subjects with vaccine pneumococcal serotype antibody concentrations above the cut-off value

Timeframe: Before (pre) and one month after (post) the booster administration

Number of subjects with opsonophagocytic activity against vaccine pneumococcal serotypes above the cut-off value

Timeframe: Before (pre) and one month after (post) the booster administration

Number of subjects with cross-reactive pneumococcal serotype antibody concentrations above the cut-off value

Timeframe: Before (pre) and one month after (post) the booster administration

Number of subjects with opsonophagocytic activity against cross-reactive pneumococcal serotypes above the cut-off value

Timeframe: Before (pre) and one month after (post) the booster administration

Number of subjects with anti-protein D antibody concentrations above the cut-off value

Timeframe: Before (pre) and one month after (post) the booster administration

Number of subjects with meningococcal serogroup C serum bactericidal assay titer above the cut-off value

Timeframe: Before (pre) and one month after (post) the booster administration

Number of subjects with anti-meningococcal polysaccharide C antibody concentrations above the cut-off value

Timeframe: Before (pre) and one month after (post) the booster administration

Number of subjects with anti-polyribosyl-ribitol phosphate antibody concentrations above the cut-off value

Timeframe: Before (pre) and one month after (post) the booster administration

Interventions:
  • Biological/vaccine: Pneumococcal conjugate vaccine GSK1024850A
  • Biological/vaccine: Prevenar
  • Biological/vaccine: Infanrix hexa
  • Biological/vaccine: Infanrix IPV Hib
  • Biological/vaccine: Infanrix penta
  • Biological/vaccine: Infanrix IPV
  • Biological/vaccine: Meningitec
  • Biological/vaccine: NeisVac-C
  • Biological/vaccine: Menitorix
  • Enrollment:
    1437
    Primary completion date:
    2008-21-01
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Chevallier B et al. (2009) Safety and reactogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) when coadministered with routine childhood vaccines. Pediatr Infect Dis J. 28(4 Suppl):S109-S118.
    Knuf M et al. (2009) Immunogenicity of routinely used childhood vaccines when coadministered with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Pediatr Infect Dis J. 28(4 Suppl):S97-S108.
    Wysocki J et al. (2009) Immunogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) when coadministered with different neisseria meningitidis serogroup C conjugate vaccines. Pediatr Infect Dis J. 28(4 Suppl):S77-88.
    Silfverdal SA et al. (2016) Safety profile of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Expert Rev Vaccines. [Epub ahead of print]
    Medical condition
    Hepatitis B, acellular pertussis, Tetanus, Poliomyelitis, Diphtheria, Streptococcus pneumoniae Vaccines
    Product
    GSK1024850A
    Collaborators
    Not applicable
    Study date(s)
    April 2007 to June 2008
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    11 - 18 months
    Accepts healthy volunteers
    Yes
    • Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
    • A male or female between, and including, 11-18 months of age at the time of the booster vaccination.
    • Concurrently participating in another clinical study, at any time during the study period (active phase and extended safety follow-up), in which the subject has been or will be exposed to an investigational or a non-investigational product.
    • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within one month preceding the booster dose of study vaccines, or planned use during the entire study period

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Valladolid, Spain, 47010
    Status
    Study Complete
    Location
    GSK Investigational Site
    Tona/Barcelona, Spain, 08551
    Status
    Study Complete
    Location
    GSK Investigational Site
    Worms, Rheinland-Pfalz, Germany, 67547
    Status
    Study Complete
    Location
    GSK Investigational Site
    Loehne, Nordrhein-Westfalen, Germany, 32584
    Status
    Study Complete
    Location
    GSK Investigational Site
    Vélez-Málaga / Málaga, Spain, 29700
    Status
    Study Complete
    Location
    GSK Investigational Site
    Bretten, Baden-Wuerttemberg, Germany, 75015
    Status
    Study Complete
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    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
    2008-21-01
    Actual study completion date
    2008-14-06

    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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