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

August 18, 2006
October 18, 2006
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Anti-HBs conc >=10 mIU/ml, 1 month after the last vaccine dose
Same as current
Complete list of historical versions of study NCT00366366 on Archive Site
  • Ab conc/titers against all vaccine antigens
  • Safety: Solicited symptoms, unsolicited AEs and SAEs
Same as current
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To Evaluate Immunogenicity & Safety of GSK Bio’s DTPa-HBV-IPV/Hib (Mixed Vaccine) and DTPa-IPV/Hib + HBV Vaccines
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
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.
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Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Diphtheria
  • Tetanus
  • Pertussis
  • Hepatitis B
  • Polio
  • Haemophilus Influenzae Type B
Biological: Infanrix-Hexa
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Lim FS, Han HH, Jacquet JM, Bock HL. Primary vaccination of infants against hepatitis B can be completed using a combined hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliomyelitis-Haemophilus influenzae type B vaccine. Ann Acad Med Singapore. 2007 Oct;36(10):801-6.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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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.
11 Weeks to 17 Weeks   (Child)
Contact information is only displayed when the study is recruiting subjects
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Study Director: Clinical Trials GlaxoSmithKline
September 2006

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