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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.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00366366
First received: August 18, 2006
Last updated: September 15, 2016
Last verified: September 2016

August 18, 2006
September 15, 2016
September 2001
September 2002   (final data collection date for primary outcome measure)
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 ClinicalTrials.gov Archive Site
  • Ab conc/titers against all vaccine antigens
  • Safety: Solicited symptoms, unsolicited AEs and SAEs
Same as current
Not Provided
Not Provided
 
To Evaluate Immunogenicity & Safety of GSK Bio's DTPa-HBV-IPV/Hib (Mixed Vaccine) and DTPa-IPV/Hib + HBV Vaccines
Phase III, Open, Randomised Immunogenicity and Reactogenicity Study to Assess the Interchangeability Between GSK Bios' DTPa-HBV-IPV/Hib and DTPa-IPV/Hib + HBV at 3rd Dose of Primary Vac. Course in Children Who Received HBV Vac. at Birth and One Month of Age and DTPa-IPV/Hib Vac at 3-4 Mth 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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Hepatitis B
Biological: Infanrix-Hexa
Not Provided
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
September 2002
September 2002   (final data collection date for primary outcome measure)

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.
Both
11 Weeks to 17 Weeks   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
Singapore
 
NCT00366366
217744/075
Not Provided
Yes
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
September 2016

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