Last updated: 11/15/2018 20:20:16

An open randomized study to evaluate the immunogenicity and reactogenicity of SmithKline Beecham Biologicals' combined hepatitis A/hepatitis B vaccine compared to separate vaccinations with commercially available hepatitis A and hepatitis B vaccines of SmithKline Beecham Biologicals, when injected in healthy adult volunteers

GSK study ID
208127/049
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: An open randomized study to evaluate the immunogenicity and reactogenicity of SmithKline Beecham Biologicals' combined hepatitis A/hepatitis B vaccine compared to separate vaccinations with commercially available hepatitis A and hepatitis B vaccines of SmithKline Beecham Biologicals, when injected in healthy adult volunteers
Trial description: An open randomized study to evaluate the immunogenicity and reactogenicity of SmithKline Beecham Biologicals' combined hepatitis A/hepatitis B vaccine compared to separate vaccinations with commercially available hepatitis A and hepatitis B vaccines of SmithKline Beecham Biologicals, when injected in healthy adult volunteers
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:
Nothdurft HD et al. (2004) Accelerated vaccination schedules provide protection against hepatitis A and B in last-minute travelers. J Travel Med. 11(4):260-262.
Medical condition
Hepatitis A
Product
Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine
Collaborators
Not applicable
Study date(s)
April 1997 to February 1999
Type
Not applicable
Phase
3

Participation criteria

Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable

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
1999-28-02

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
Participate in clinical trial
Access to clinical trial data by researchers
Visit website