Primary and Booster Vaccination Study With Pneumococcal Vaccine GSK1024850A in Healthy Japanese Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01027845
First received: December 7, 2009
Last updated: July 24, 2012
Last verified: September 2011

December 7, 2009
July 24, 2012
December 2009
September 2011   (final data collection date for primary outcome measure)
Evaluation of immune responses to components of the investigational pneumococcal vaccine [ Time Frame: One month after primary immunization ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01027845 on ClinicalTrials.gov Archive Site
  • Evaluation of immune responses to components of the study vaccines for additional parameters [ Time Frame: One month after primary immunization and prior to and one month after booster immunization ] [ Designated as safety issue: No ]
  • Solicited local and general adverse events [ Time Frame: Within 8 days (Day 0-Day 7) after each vaccine dose ] [ Designated as safety issue: No ]
  • Unsolicited adverse events [ Time Frame: Within 31 days (Day 0-Day 30) after each vaccination ] [ Designated as safety issue: No ]
  • Serious adverse events [ Time Frame: From dose 1 up to study end ] [ Designated as safety issue: No ]
  • Evaluation of immune responses to components of the study vaccines for additional parameters [ Time Frame: One month after primary immunization and prior to and one month after booster immunization ] [ Designated as safety issue: No ]
  • Unsolicited adverse events [ Time Frame: Within 31 days (Day 0-Day 30) after each vaccination ] [ Designated as safety issue: No ]
  • Serious adverse events [ Time Frame: From dose 1 up to study end ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Primary and Booster Vaccination Study With Pneumococcal Vaccine GSK1024850A in Healthy Japanese Children
Immunogenicity, Safety and Reactogenicity of GlaxoSmithKline Biologicals' Pneumococcal Vaccine 1024850A Following Primary and Booster Vaccination of Healthy Japanese Children

This study will aim to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' 10-valent pneumococcal conjugate vaccine GSK1024850A when co-administered with Japanese DTPa vaccine as a 3-dose primary immunization course in healthy Japanese children at 3, 4 and 5 months of age and as a booster vaccination at 17-19 months of age.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Streptococcus Pneumoniae
  • Pneumococcal Disease
  • Biological: Pneumococcal vaccine GSK1024850A
    Intramuscular injection, 4 doses
  • Biological: DTPa
    Subcutaneous injection, 4 doses
    Other Name: DPT "KAKETSUKEN" Syringe
  • Experimental: 10Pn Group
    Interventions:
    • Biological: Pneumococcal vaccine GSK1024850A
    • Biological: DTPa
  • Active Comparator: DTPa Group
    Intervention: Biological: DTPa
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
360
September 2011
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects who the investigator/co-investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR(s)) can and will comply with the requirements of the protocol.
  • A male or female between, and including, 90 and 118 days of age (3 months) at the time of the first vaccination.
  • Written informed consent obtained from the parent(s)/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:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine(s), 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 period starting from 30 days before the first dose of study vaccine(s) and ending on the last study visit, with the exception of Haemophilus influenzae type b vaccine, Hepatitis B Vaccine, Bacille Calmette-Guérin vaccine, Oral Polio Vaccine, Japanese encephalitis, measles and rubella, varicella, mumps, and 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 (pharmaceutical product or device).
  • Administration of any pneumococcal vaccine since birth except for the DTPa group for whom vaccination with a licensed pneumococcal vaccine by catch-up schedule will be allowed only if the 2 vaccine doses are administered between Study Visit 4 and 5, i.e. from the second blood sampling timepoint (Visit 4) onwards and up to 7 days before the booster dose of the DTPa vaccine.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
  • History of, or intercurrent diphtheria, tetanus, pertussis disease.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccines.
  • Major congenital defects or serious chronic illness.
  • History of any seizures or progressive neurological disease.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
  • Child in care.
  • Acute disease and/or fever at the time of enrolment.
Both
90 Days to 118 Days
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01027845
112640
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
September 2011

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