Safety & Immunogenicity of Pneumococcal Vaccine 2189242A Co-administered With DTPa-HBV-IPV/Hib in Healthy Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01204658
First received: September 16, 2010
Last updated: May 1, 2014
Last verified: May 2013

September 16, 2010
May 1, 2014
September 2010
October 2012   (final data collection date for primary outcome measure)
Occurrence of fever >40.0°C (rectal temperature) with causal relationship to vaccination [ Time Frame: Within 7 days (Day 0-6) following at least one dose of the primary vaccination. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01204658 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 3, before booster dose and one month post-booster dose ] [ Designated as safety issue: No ]
  • Evaluation of the immune responses to components of the co-administered DTPa-HBV-IPV/Hib vaccine [ Time Frame: One month post-dose 3, 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 Co-administered With DTPa-HBV-IPV/Hib in Healthy Infants
Safety, Reactogenicity & Immunogenicity of GSK Biologicals' Pneumococcal Vaccine 2189242A When Co-administered With DTPa-HBV-IPV/Hib Vaccine in Healthy Infants

This study will assess the safety, reactogenicity and immunogenicity of two formulations of GSK Biologicals' pneumococcal vaccine 2189242A given as a 3-dose primary vaccination course during the first 6 months of life followed by a booster dose at 12-15 months of age and co-administered with DTPa-HBV-IPV/Hib vaccine.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Infections, Streptococcal
  • Biological: Pneumococcal vaccine GSK2189242A (formulation 1)
    Four doses will be administered intramuscularly, at approximately 2, 3, 4 and 12-15 months of age.
  • Biological: Pneumococcal vaccine GSK2189242A (formulation 2)
    Four doses will be administered intramuscularly, at approximately 2, 3, 4 and 12-15 months of age.
  • Biological: Synflorix
    Four doses will be administered intramuscularly, at approximately 2, 3, 4 and 12-15 months of age.
  • Biological: Prevenar 13
    Four doses will be administered intramuscularly, at approximately 2, 3, 4 and 12-15 months of age.
  • Biological: Infanrix Hexa (DTPa-HBV-IPV/Hib)
    Four doses will be co-administered intramuscularly, at approximately 2, 3, 4 and 12-15 months of age.
  • Experimental: Group 1
    Children receiving pneumococcal vaccine GSK2189242A (formulation 1)
    Interventions:
    • Biological: Pneumococcal vaccine GSK2189242A (formulation 1)
    • Biological: Infanrix Hexa (DTPa-HBV-IPV/Hib)
  • Experimental: Group 2
    Children receiving pneumococcal vaccine GSK2189242A (formulation 2)
    Interventions:
    • Biological: Pneumococcal vaccine GSK2189242A (formulation 2)
    • Biological: Infanrix Hexa (DTPa-HBV-IPV/Hib)
  • Active Comparator: Group 3
    Children receiving Synflorix
    Interventions:
    • Biological: Synflorix
    • Biological: Infanrix Hexa (DTPa-HBV-IPV/Hib)
  • Active Comparator: Group 4
    Children receiving Prevenar 13
    Interventions:
    • Biological: Prevenar 13
    • Biological: Infanrix Hexa (DTPa-HBV-IPV/Hib)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
576
October 2012
October 2012   (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, 6 and 14 weeks (42-104 days) 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.
  • Born after a gestation period of 36 to 42 weeks inclusive.

Exclusion Criteria:

  • Child in care.
  • 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 since birth.
  • 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), with the exception of licensed flu vaccines.
  • 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.
  • Previous vaccination against S. pneumoniae since birth.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • 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 >= 38.0°C on rectal setting or >= 37.5°C on oral or axillary 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 since birth or planned administration during the primary epoch and during the period starting three months before booster vaccination and ending one month after the booster vaccination.
Both
6 Weeks to 14 Weeks
Yes
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Germany,   Poland,   Sweden
 
NCT01204658
113994
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
May 2013

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