Last updated: 11/07/2018 00:12:34
Immunogenicity and protective efficacy of SmithKline Beecham Biological’s recombinant-DNA hepatitis B vaccine (10µg) in newborns of HbeAg+ and HbsAg+ mothers in comparison with a historical control group
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Immunogenicity and protective efficacy of SmithKline Beecham Biological’s recombinant-DNA hepatitis B vaccine (10µg) in newborns of HbeAg+ and HbsAg+ mothers in comparison with a historical control group
Trial description: Immunogenicity and protective efficacy of SmithKline Beecham Biological’s recombinant-DNA hepatitis B vaccine (10µg) in newborns of HbeAg+ and HbsAg+ mothers in comparison with a historical control group
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. (1990) Comparison of a recombinant DNA hepatitis B vaccine alone or in combination with hepatitis B immune globulin for the prevention of perinatal acquisition of hepatitis B carriage. Vaccine. 8 (Suppl 1):S134-139.
Poovorawan Y et al. (1992) Long term efficacy of hepatitis B vaccine in infants born to hepatitis B e antigen-positive mothers. Pediatr Infect Dis J. 11(10):816-821.
Medical condition
Hepatitis B
Product
Hepatitis B Vaccine, Recombinant
Collaborators
Not applicable
Study date(s)
July 1992 to August 1993
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
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
1993-02-08
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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