Last updated: 11/03/2018 06:41:28
A phase III, double-blind, randomized, comparative, multicenter study of the immunogenicity and safety of three doses of GlaxoSmithKline Biologicals' thimerosal-free hepatitis B vaccine (10 µg/0.5 mL) compared to the US-licensed GlaxoSmithKline Biologicals' preservative-free hepatitis B vaccine (Engerix-B, 10 µg/0.5 mL) when administered intramuscularly on a 0, 1, 6-month schedule to healthy infants in their first two weeks of life
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A phase III, double-blind, randomized, comparative, multicenter study of the immunogenicity and safety of three doses of GlaxoSmithKline Biologicals' thimerosal-free hepatitis B vaccine (10 µg/0.5 mL) compared to the US-licensed GlaxoSmithKline Biologicals' preservative-free hepatitis B vaccine (Engerix-B, 10 µg/0.5 mL) when administered intramuscularly on a 0, 1, 6-month schedule to healthy infants in their first two weeks of life
Trial description: A phase III, double-blind, randomized, comparative, multicenter study of the immunogenicity and safety of three doses of GlaxoSmithKline Biologicals' thimerosal-free hepatitis B vaccine (10 µg/0.5 mL) compared to the US-licensed GlaxoSmithKline Biologicals' preservative-free hepatitis B vaccine (Engerix-B, 10 µg/0.5 mL) when administered intramuscularly on a 0, 1, 6-month schedule to healthy infants in their first two weeks of life
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:
2005-29-03
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Hepatitis B Vaccine
Product
SKF103860
Collaborators
Not applicable
Study date(s)
April 2002 to March 2005
Type
Not applicable
Phase
2/3
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
2005-29-03
Actual study completion date
2005-29-03
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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