Last updated: 11/07/2018 13:17:23
Study to assess immunogenicity, safety and reactogenicity of GSK Biologicals DTPa-IPV/Hib and HBV vaccines compared to an investigational vaccination regimen in healthy infants born to hepatitis B surface antigen negative mothers and previously primed at birth with a dose of GSK Biologicals' hepatitis B vaccine
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Study to assess immunogenicity, safety and reactogenicity of GSK Biologicals DTPa-IPV/Hib and HBV vaccines compared to an investigational vaccination regimen in healthy infants born to hepatitis B surface antigen negative mothers and previously primed at birth with a dose of GSK Biologicals' hepatitis B vaccine
Trial description: Study to assess immunogenicity, safety and reactogenicity of GSK Biologicals DTPa-IPV/Hib and HBV vaccines compared to an investigational vaccination regimen in healthy infants born to hepatitis B surface antigen negative mothers and previously primed at birth with a dose of GSK Biologicals' hepatitis B vaccine
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Kock Cheng H. et al. (2004) Immunogenicity and reactogenicity of two regimens of diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio and Haemophilus influenzae type B vaccines administered to infants primed at birth with hepatitis B vaccine. SouthEast Asian J Trop Med Public Health. 35(3): 685-692.
Medical condition
Hepatitis B
Product
Hepatitis B Vaccine, Recombinant
Collaborators
Not applicable
Study date(s)
August 2000 to May 2001
Type
Not applicable
Phase
3
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2001-02-05
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Not applicable
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Access to clinical trial data by researchers
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