Safety & Immunogenicity of Pneumococcal Vaccine 2189242A in Children Aged 12-23 Months at the Time of First Vaccination

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00985751
First received: September 24, 2009
Last updated: May 26, 2011
Last verified: May 2011

September 24, 2009
May 26, 2011
November 2009
March 2011   (final data collection date for primary outcome measure)
Occurrence of fever >40.0°C (rectal temperature) [ Time Frame: Within 7 days (Day 0-6) following at least one dose of the primary vaccinations. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00985751 on ClinicalTrials.gov Archive Site
  • Occurrence of each solicited local and general adverse events [ Time Frame: Within 7 days (Day 0-6) after each vaccination ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited adverse events [ Time Frame: Within 31 days (Day 0-30) after each vaccination ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events [ Time Frame: From the first vaccine dose up to study end ] [ Designated as safety issue: No ]
  • Evaluation of the immune responses to components of the investigational vaccines [ Time Frame: One month post-dose 2, before booster dose and one month post-booster dose ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety & Immunogenicity of Pneumococcal Vaccine 2189242A in Children Aged 12-23 Months at the Time of First Vaccination
Safety, Reactogenicity & Immunogenicity of GSK Biologicals' Pneumococcal Vaccine 2189242A in Children Aged 12-23 Months at the Time of First Vaccination

This study will assess the safety, reactogenicity and immunogenicity of different formulations of GSK Biologicals' pneumococcal vaccine 2189242A when administered alone or in combination with the 10-valent pneumococcal conjugate vaccine (GSK1024850A vaccine) as a 2-dose primary vaccination course followed by a booster dose in healthy children aged 12-23 months at the time of first vaccination. Considering that febrile reactions are frequently observed following pneumococcal vaccination, usually co-administered with other routine paediatric vaccines, the primary study objective will focus on evaluating the increase in grade 3 fever (i.e. rectal temperature >40.0°C).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
  • Pneumococcal Disease
  • Haemophilus Influenzae Infections
  • Biological: Pneumococcal vaccine GSK2189242A (formulation 1)
    Three doses will be administered intramuscularly, at Month 0, 2 and 6.
  • Biological: Pneumococcal vaccine GSK2189242A (formulation 2)
    Three doses will be administered intramuscularly, at Month 0, 2 and 6
  • Biological: Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 3)
    Three doses will be administered intramuscularly, at Month 0, 2 and 6
  • Biological: Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 4)
    Three doses will be administered intramuscularly, at Month 0, 2 and 6
  • Biological: Pneumococcal vaccine GSK1024850A
    Three doses will be administered intramuscularly, at Month 0, 2 and 6
  • Experimental: Group 1
    Intervention: Biological: Pneumococcal vaccine GSK2189242A (formulation 1)
  • Experimental: Group 2
    Intervention: Biological: Pneumococcal vaccine GSK2189242A (formulation 2)
  • Experimental: Group 3
    Intervention: Biological: Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 3)
  • Experimental: Group 4
    Intervention: Biological: Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 4)
  • Experimental: Control Group
    Intervention: Biological: Pneumococcal vaccine GSK1024850A
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
257
March 2011
March 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol
  • Male or female between, and including, 12 and 23 months of age at the time of the first vaccination.
  • Written informed consent obtained from the parents/LAR(s) of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

  • Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
  • Planned administration/administration of a vaccine not foreseen by the study protocol during the study period starting from 30 days before each dose and ending 30 days after each dose of vaccine(s).
  • Previous vaccination against S. pneumoniae since birth.
  • History of any hypersensitivity reaction following any previous vaccination.
  • Eczema and any history of allergy
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required), including human immunodeficiency virus infection.
  • A family history of congenital or hereditary immunodeficiency.
  • Major congenital defects or any chronic illness.
  • History of any neurologic disorders or seizures.
  • Acute disease and/or fever at the time of enrolment.
  • Fever is defined as temperature >= 37.5°C on oral or axillary setting, or >= 38.0°C on rectal setting.
  • Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
  • Administration of immunoglobulins and/ or any blood products within the 3 months preceding the first dose of study vaccine or planned use during the study period.
  • Child in care.
Both
12 Months to 23 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Czech Republic
 
NCT00985751
113171
Not Provided
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
May 2011

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