To Evaluate Immunogenicity & Safety of GSK Bio’s DTPa-HBV-IPV/Hib (Mixed Vaccine) and DTPa-IPV/Hib + HBV Vaccines

This study has been completed.
Information provided by:
GlaxoSmithKline Identifier:
First received: August 18, 2006
Last updated: October 18, 2006
Last verified: September 2006
This study assessed the immunogenicity and safety of two vaccination regimens that employed either GSK Biologicals’ combined DTPa-HBV-IPV/Hib vaccine or DTPa-IPV/Hib vaccine. In the two groups, infants received the DTPa-IPV/Hib vaccine at 3 and 4 months of age, as the first 2 doses of the primary vaccination course. At 5 months of age, they received either the DTPa-IPV/Hib vaccine co-administered with the HBV vaccine or a dose of the DTPa-HBV-IPV/Hib vaccine as a 3rd dose. Infants in the two groups had previously received 2 doses of HBV vaccine at birth and at 1 month of age.

Condition Intervention Phase
Hepatitis B
Haemophilus Influenzae Type B
Biological: Infanrix-Hexa
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: To Assess Interchangeability b/w GSK Bio’s DTPa-HBV-IPV/Hib (Mixed Vaccine) & DTPa-IPV/Hib + HBV at 3rd Dose of Primary Vaccination Course in Children Who Received HBV Vaccine at Birth & 1 Mth & DTPa-IPV/Hib Vaccine at 3 & 4 Mths of Age

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Anti-HBs conc >=10 mIU/ml, 1 month after the last vaccine dose

Secondary Outcome Measures:
  • Ab conc/titers against all vaccine antigens
  • Safety: Solicited symptoms, unsolicited AEs and SAEs

Estimated Enrollment: 150

Ages Eligible for Study:   11 Weeks to 17 Weeks   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • A male or female infant at the age of 11 - 17 weeks.
  • Written informed consent obtained from the parents or guardians of the subject.
  • Free of obvious health problems as established by clinical examination before entering into the study.
  • Hepatitis B vaccine at birth and one month of age.

Exclusion Criteria:

  • Previous vaccination against measles, mumps, rubella and/or varicella.
  • Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • A family history of congenital or hereditary immunodeficiency.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection.
  • Major congenital defects.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00366366

GSK Clinical Trials Call Center
Choa Chu Kang, Singapore
Sponsors and Collaborators
Study Director: Clinical Trials GlaxoSmithKline
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00366366     History of Changes
Other Study ID Numbers: 217744/075 
Study First Received: August 18, 2006
Last Updated: October 18, 2006
Health Authority: Singapore: Health Sciences Authority

Additional relevant MeSH terms:
Hepatitis B
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Immunologic Factors
Physiological Effects of Drugs processed this record on August 23, 2016