Last updated: 11/03/2018 13:53:21

Booster Vaccination Study with a Pneumococcal Vaccine in children primed with the same vaccine

GSK study ID
112933
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 or Prevenar™ co-administered with Hiberix™ in children primed with the same vaccines
Trial description: The purpose of this study is to evaluate the reactogenicity, safety and immunogenicity of a booster (fourth) dose of pneumococcal vaccine GSK1024850A when co-administered with Hiberix at 12-18 months of age, in children primed with the same vaccines in primary study NCT00680914.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Single (Participant)
Allocation:
Non-randomized
Primary outcomes:

Number of subjects reporting grade 3 adverse events

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

Secondary outcomes:

Number of subjects reporting solicited symptoms

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

Number of subjects reporting unsolicited adverse events

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

Number of subjects reporting serious adverse events

Timeframe: After booster vaccination up to study end (Month 0 to Month 1)

Concentration of antibodies against vaccine pneumococcal serotypes

Timeframe: One month after booster vaccination (Month 1)

Opsonophagocytic activity against vaccine pneumococcal serotypes

Timeframe: One month after booster vaccination (Month 1)

Concentration of antibodies against cross-reactive pneumococcal serotypes 6A and 19A

Timeframe: One month after booster vaccination (Month 1)

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

Timeframe: One month after booster vaccination (Month 1)

Concentration of antibodies against protein D (PD)

Timeframe: One month after booster vaccination (Month 1)

Concentration of antibodies against polyribosyl-ribitol-phosphate (PRP)

Timeframe: One month after booster vaccination (Month 1)

Interventions:
  • Biological/vaccine: GSK Biologicals’ Synflorix™ (Pneumococcal vaccine GSK1024850A)
  • Biological/vaccine: Wyeth-Lederle’s Prevenar™
  • Biological/vaccine: GSK Biologicals’ Hiberix™
  • Enrollment:
    450
    Primary completion date:
    2010-11-01
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Kim CH et al. (2011) Response to Primary and Booster vaccination with 10-valent Pneumococcal nontypeable Haemophilus influenzae Protein D conjugate vaccine in Korean Infants. Pediatr Infect Dis J. 30(12):e235-e243.
    Kim CH et al. Immunogenicity and safety of 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Korean children. Abstract presented at the Korean Society of Pediatric Infectious Diseases - 2011 Spring Conference. Seoul, South Korea, 7-11 June 2011.
    Kim JS et al. Safety and reactogenicity of booster vaccination with 10-valent pneumococcal non-typeable Haemophilus influenzae protein d conjugate vaccine (PHiD-CV) in Korean children. Abstract presented at the 8th International Symposium on Antimicrobial Agents and Resistance (ISAAR). Seoul, Republic of Korea, 6-8 April 2011.
    Kim KH et al. Immunogenicity of booster vaccination with 10-valent pneumococcal non-typeable Haemophilus influenzae protein d conjugate vaccine (PHiD-CV) in Korean children. Abstract presented at the 8th International Symposium on Antimicrobial Agents and Resistance (ISAAR). Seoul, Republic of Korea, 6-8 April 2011.
    Medical condition
    Infections, Streptococcal
    Product
    GSK1024850A
    Collaborators
    Not applicable
    Study date(s)
    June 2009 to January 2010
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    12 - 18 months
    Accepts healthy volunteers
    Yes
    • A male or female between, and including, 12-18 months of age at the time of booster 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) within 30 days preceding the 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 (pharmaceutical product or device).

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Iksan, South Korea, 570-711
    Status
    Study Complete
    Location
    GSK Investigational Site
    Jeju City, South Korea, 690-121
    Status
    Study Complete
    Location
    GSK Investigational Site
    Bucheon-Si, GyeongGi-do,, South Korea, 420-767
    Status
    Study Complete
    Location
    GSK Investigational Site
    Gyeonggi-do, South Korea, 411-706
    Status
    Study Complete
    Location
    GSK Investigational Site
    Suwon City, Gyeonggi-do, South Korea, 442-723
    Status
    Study Complete
    Location
    GSK Investigational Site
    Seoul, South Korea, 150-719
    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
    2010-11-01
    Actual study completion date
    2010-11-01

    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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