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Vaccination Course in Primed Children and Age-matched Unprimed Children With Pneumococcal Vaccine GSK1024850A

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00792909
First received: November 17, 2008
Last updated: November 15, 2012
Last verified: November 2012

November 17, 2008
November 15, 2012
December 2008
July 2009   (final data collection date for primary outcome measure)
Concentrations of antibodies against vaccine pneumococcal serotypes [ Time Frame: 7-10 days after immunization or the first vaccine dose ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00792909 on ClinicalTrials.gov Archive Site
  • Immune responses (= antibody concentrations) against components of the investigational pneumococcal conjugate vaccine [ Time Frame: Prior to immunization (day 0) ] [ Designated as safety issue: No ]
  • Immune responses (= antibody concentrations) against components of the investigational pneumococcal conjugate vaccine. [ Time Frame: 7-10 days after immunization or the first vaccine dose ] [ Designated as safety issue: No ]
  • Immune responses (= antibody concentrations) against components of investigational pneumococcal conjugate vaccine [ Time Frame: Prior to immunization and 7-10 days after immunization or the first vaccine dose ] [ Designated as safety issue: No ]
  • In a subset of subjects: immune responses (= antibody concentrations) against components of the investigational pneumococcal conjugate vaccine [ Time Frame: One month after the second vaccine dose (month 3) ] [ Designated as safety issue: No ]
  • Occurrence of solicited adverse events [ Time Frame: Within 4 (day 0-3) days after vaccination ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited adverse events [ Time Frame: Within 31 (day 0-30) days after vaccination ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events [ Time Frame: Following vaccination (day 0) and throughout the entire study period (until Month 1 or Month 3) ] [ Designated as safety issue: No ]
  • Immune responses against components of the investigational pneumococcal conjugate vaccine [ Time Frame: Prior to immunization ] [ Designated as safety issue: No ]
  • Immune responses against components of the investigational pneumococcal conjugate vaccine [ Time Frame: 7-10 days after immunization or the first vaccine dose ] [ Designated as safety issue: No ]
  • Immune responses against components of the investigational pneumococcal conjugate vaccine [ Time Frame: Prior to immunization and 7-10 days after immunization or the first vaccine dose ] [ Designated as safety issue: No ]
  • In a subset of subjects: immune responses against components of the investigational pneumococcal conjugate vaccine [ Time Frame: One month after the second vaccine dose ] [ Designated as safety issue: No ]
  • Occurrence of solicited adverse events [ Time Frame: Within 4 days after vaccination ] [ Designated as safety issue: Yes ]
  • Occurrence of unsolicited adverse events [ Time Frame: Within 31 days after vaccination ] [ Designated as safety issue: Yes ]
  • Occurrence of serious adverse events [ Time Frame: Following vaccination and throughout the entire study period. ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Vaccination Course in Primed Children and Age-matched Unprimed Children With Pneumococcal Vaccine GSK1024850A
Vaccination Course in Children Primed and Boosted With Pneumococcal Vaccine GSK 1024850A and in Age-matched Unprimed Children

The purpose of this study is to assess the immune memory induced by primary and booster vaccination with pneumococcal conjugate vaccine GSK1024850A in the first year of life through evaluation of the immune responses following vaccination with a booster dose of pneumococcal conjugate vaccine GSK1024850A in the fourth year of life and to assess immune responses following vaccination with a single dose of pneumococcal conjugate vaccine GSK1024850A in age-matched unprimed children.

The study also aims to assess the antibody persistence in the fourth year of life following primary and booster vaccination with pneumococcal conjugate vaccine GSK1024850A in the first year of life.

The study is also designed to evaluate the immunogenicity in terms of antibody response and the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following a 2-dose vaccination with pneumococcal conjugate vaccine GSK1024850A in the fourth year of life.

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 = 00307034)

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Pneumococcal Disease
  • Biological: Pneumococcal conjugate vaccine GSK1024850A
    Intramuscular injection, 1 dose
  • Biological: Pneumococcal conjugate vaccine GSK1024850A
    Intramuscular injection, 2 doses
  • Experimental: Group A
    Subjects previously vaccinated with pneumococcal conjugate vaccine GSK1024850A according to a 2+1 schedule in the first year of life receiving a booster dose of GSK1024850A in the fourth year of life.
    Intervention: Biological: Pneumococcal conjugate vaccine GSK1024850A
  • Experimental: Group B
    Subjects previously vaccinated with pneumococcal conjugate vaccine GSK1024850A according to a 3+1 schedule in the first year of life receiving a booster dose of GSK1024850A in the fourth year of life.
    Intervention: Biological: Pneumococcal conjugate vaccine GSK1024850A
  • Active Comparator: Group C
    Age-matched unprimed subjects receiving 2 doses of pneumococcal conjugate vaccine GSK1024850A in the fourth year of life.
    Intervention: Biological: Pneumococcal conjugate vaccine GSK1024850A

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
172
July 2009
July 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female between, and including, +- 36-46 months of age at the time of vaccination.
  • For primed subjects: having completed the full vaccination course with GSK1024850A in the primary study (NCT00307034).
  • Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol.
  • Written informed consent obtained from the parent(s)/guardian(s) of the subject.
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of the study vaccines, or planned use during the study period.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to vaccination.
  • For primed subjects: administration of any pneumococcal vaccine since the end of the primary study (NCT00307034).
  • For unprimed subjects: previous vaccination with any pneumococcal vaccine.
  • Administration of immunoglobulins and/or any blood products less than 6 months prior to the vaccination or planned administration during the study period.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
  • History of reactions or allergic disease likely to be exacerbated by any component of the study vaccine.
  • Acute disease at the time of enrolment.
Both
36 Months to 46 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Slovakia,   Sweden
 
NCT00792909
111736
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP