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
  Purpose

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.


Condition Intervention Phase
Streptococcus Pneumoniae
Pneumococcal Disease
Biological: Pneumococcal vaccine GSK1024850A
Biological: DTPa
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Immunogenicity, Safety and Reactogenicity of GlaxoSmithKline Biologicals' Pneumococcal Vaccine 1024850A Following Primary and Booster Vaccination of Healthy Japanese Children

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Evaluation of immune responses to components of the investigational pneumococcal vaccine [ Time Frame: One month after primary immunization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 360
Study Start Date: December 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 10Pn Group Biological: Pneumococcal vaccine GSK1024850A
Intramuscular injection, 4 doses
Biological: DTPa
Subcutaneous injection, 4 doses
Other Name: DPT "KAKETSUKEN" Syringe
Active Comparator: DTPa Group Biological: DTPa
Subcutaneous injection, 4 doses
Other Name: DPT "KAKETSUKEN" Syringe

  Eligibility

Ages Eligible for Study:   90 Days to 118 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01027845

Locations
Japan
GSK Investigational Site
Aichi, Japan, 451-0052
GSK Investigational Site
Chiba, Japan, 299-4503
GSK Investigational Site
Hiroshima, Japan, 730-8562
GSK Investigational Site
Hiroshima, Japan, 720-8520
GSK Investigational Site
Hokkaido, Japan, 003-0021
GSK Investigational Site
Kagawa, Japan, 765-8501
GSK Investigational Site
Kanagawa, Japan, 243-8551
GSK Investigational Site
Kanagawa, Japan, 238-8567
GSK Investigational Site
Kanagawa, Japan, 247-8533
GSK Investigational Site
Nagasaki, Japan, 856-8562
GSK Investigational Site
Niigata, Japan, 957-8588
GSK Investigational Site
Okayama, Japan, 701-0205
GSK Investigational Site
Osaka, Japan, 560-0004
GSK Investigational Site
Osaka, Japan, 555-0001
GSK Investigational Site
Osaka, Japan, 591-8025
GSK Investigational Site
Tokyo, Japan, 152-0021
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01027845     History of Changes
Other Study ID Numbers: 112640
Study First Received: December 7, 2009
Last Updated: July 24, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:
Pneumococcal disease
Immunogenicity
Booster vaccination
Pneumococcal vaccine
Primary vaccination
Safety

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on August 27, 2014