Last updated: 11/15/2018 20:20:23
An open study to evaluate the immunogenicity, safety, and reactogenicity of SmithKline Beecham Biologicals’ commercially available combined hepatitis A/hepatitis B vaccine containing 720 ELISA units of hepatitis A antigen and 20 mcg of hepatitis B surface antigen, administered following a 2 dose schedule in healthy children
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: An open study to evaluate the immunogenicity, safety, and reactogenicity of SmithKline Beecham Biologicals’ commercially available combined hepatitis A/hepatitis B vaccine containing 720 ELISA units of hepatitis A antigen and 20 mcg of hepatitis B surface antigen, administered following a 2 dose schedule in healthy children
Trial description: An open study to evaluate the immunogenicity, safety, and reactogenicity of SmithKline Beecham Biologicals’ commercially available combined hepatitis A/hepatitis B vaccine containing 720 ELISA units of hepatitis A antigen and 20 mcg of hepatitis B surface antigen, administered following a 2 dose schedule in healthy children
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:
Van Damme P et al. (2001) Combining Hepatitis A and B vaccination in children and adolescents. Vaccine. 19(17-19):2407-2412.
Van Der Wielen M et al. (2000) A two-dose schedule for combined hepatitis A and hepatitis B vaccination in children ages one to eleven years. Pediatr Infect Dis J. 19(9):848-853.
Medical condition
Hepatitis A
Product
Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine
Collaborators
Not applicable
Study date(s)
March 1998 to December 1998
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
1998-04-12
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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