Last updated: 11/03/2018 10:49:55

Assess reacto- and immunogenicity of pneumococcal conjugate vaccine when given as booster or a 2 dose catch up schedule

GSK study ID
110031
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: Phase II, observer-blind follow-up study to assess reacto-and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine (GSK1024850A), when given as booster in primed children or as 2-dose catch-up in unprimed children.
Trial description: This is a booster study in 2 groups of healthy children less than 3 years old to measure the reactogenicity, safety and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine, when given as a booster or as a two-dose catch-up vaccination.
This protocol posting deals with objectives and outcome measures of the booster phase. The objectives and outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00338351).
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Double (Care Provider, Investigator)
Allocation:
Non-randomized
Primary outcomes:

Number of subjects reporting grade 3 symptoms (solicited and unsolicited)

Timeframe: Within 4 days after the administration of any study vaccine dose

Secondary outcomes:

Number of subjects reporting solicited local symptoms

Timeframe: Within 4 days after the administration of any study vaccine dose

Number of subjects reporting solicited general symptoms

Timeframe: Within 4 days after the administration of any study vaccine dose

Number of subjects reporting unsolicited adverse events

Timeframe: Within 31 days after the administration of any study vaccine dose

Number of subjects reporting serious adverse events during the active phase of the study

Timeframe: Throughout the active phase of the study ( from the beginning of the booster phase up to 1 month after the second booster dose)

Number of subjects reporting serious adverse events throughout the entire study period

Timeframe: Throughout the entire study period (from the beginning of the booster phase up to the end of the 6-month extended safety follow-up)

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

Timeframe: Before (pre) and one month after (post) the administration of Dose 2

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

Timeframe: Before (pre) and one month after (post) the administration of Dose 2

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

Timeframe: Before (pre) and one month after (post) the administration of Dose 2

Anti-hepatitis A virus antibodies concentration

Timeframe: Before (pre) and one month after (post) the administration of Dose 2

Number of subjects With Anti-hepatitis A antibody concentrations above the cut-off value

Timeframe: Before (pre) and one month after (post) the administration of Dose 2

Interventions:
  • Biological/vaccine: Synflorix
  • Biological/vaccine: Infanrix Hexa
  • Biological/vaccine: Havrix
  • Enrollment:
    163
    Primary completion date:
    2008-20-02
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Lagos R et al. (2011) Safety and immunogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Chilean children. Hum Vaccin. 7(5):511-522.
    Lagos R et al. 10-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) given as booster dose or 2-dose catch-up in Chilean children. Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.
    Lagos R et al. (2011) Safety and immunogenicity of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Chilean children. Hum Vaccin. 7(5):511-522.
    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
    Infections, Streptococcal
    Product
    GSK1024850A
    Collaborators
    Not applicable
    Study date(s)
    August 2007 to August 2008
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 21 months
    Accepts healthy volunteers
    Yes
    • Male or female between, and including, 18-21 months of age at the time of vaccination.
    • Subjects who previously participated in the primary study and received 3 doses of study or control vaccines during the primary study.
    • Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the booster doses of study vaccines, or planned use during the study period (active phase and extended safety follow-up).
    • Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month (30 days) before the booster doses of vaccine(s) and during the active phase of the study (up to the follow-up visit (Visit 3)).

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Santiago, Región Metro De Santiago, Chile
    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
    2008-20-02
    Actual study completion date
    2008-28-08

    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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