Last updated: 11/07/2018 13:03:27
An open randomised study in healthy infants vaccinated at birth with Engerix™-B (10µg) to evaluate the immunogenicity and the reactogenicity of the following GlaxoSmithKline (GSK) Biologicals’ vaccines: 1) combined DTP-HB vaccine (10µg HBsAg), 2) combined DTP-HB vaccine (5µg HBsAg), 3) simultaneous administration of Engerix™-B (10µg) vaccine in right thigh and whole-cell DTP vaccine in left thigh, when administered at 2, 4 and 6 months of age
Clinicaltrials.gov ID
Not applicable
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: An open randomised study in healthy infants vaccinated at birth with Engerix™-B (10µg) to evaluate the immunogenicity and the reactogenicity of the following GlaxoSmithKline (GSK) Biologicals’ vaccines: 1) combined DTP-HB vaccine (10µg HBsAg), 2) combined DTP-HB vaccine (5µg HBsAg), 3) simultaneous administration of Engerix™-B (10µg) vaccine in right thigh and whole-cell DTP vaccine in left thigh, when administered at 2, 4 and 6 months of age
Trial description: An open randomised study in healthy infants vaccinated at birth with Engerix™-B (10µg) to evaluate the immunogenicity and the reactogenicity of the following GlaxoSmithKline (GSK) Biologicals’ vaccines: 1) combined DTP-HB vaccine (10µg HBsAg), 2) combined DTP-HB vaccine (5µg HBsAg), 3) simultaneous administration of Engerix™-B (10µg) vaccine in right thigh and whole-cell DTP vaccine in left thigh, when administered at 2, 4 and 6 months of age
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:
Poovorawan Y et al. (2008) Long-term antibody persistence in children primed and boosted with a DTPw-HBV vaccine at 2,4, 6,18 months of age. Vaccine. 26(12):1535-1540.
Medical condition
Hepatitis B
Product
Hepatitis B Vaccine, Recombinant
Collaborators
Not applicable
Study date(s)
March 2001 to April 2002
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
2002-02-04
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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