Last updated: 11/07/2018 13:17:57
Open, randomized, multicenter, phase IIIb clinical trial to assess the incidence of high grade fever (=>40.0°C) within 4 days following a booster dose in the second year of life of GlaxoSmithKline (GSK) Biologicals’ combined DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™) as compared to GSK Biologicals’ com bined DTPa-IPV/Hib (Infanrix™-IPV+Hib) and HBV (Engerix-B™ Kinder) vaccines administered concomitantly in separate injections to children previously primed with licensed vaccines according to the vaccination recommendations currently in place in Germany.
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Open, randomized, multicenter, phase IIIb clinical trial to assess the incidence of high grade fever (=>40.0°C) within 4 days following a booster dose in the second year of life of GlaxoSmithKline (GSK) Biologicals’ combined DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™) as compared to GSK Biologicals’ com bined DTPa-IPV/Hib (Infanrix™-IPV+Hib) and HBV (Engerix-B™ Kinder) vaccines administered concomitantly in separate injections to children previously primed with licensed vaccines according to the vaccination recommendations currently in place in Germany.
Trial description: Open, randomized, multicenter, phase IIIb clinical trial to assess the incidence of high grade fever (=>40.0°C) within 4 days following a booster dose in the second year of life of GlaxoSmithKline (GSK) Biologicals’ combined DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™) as compared to GSK Biologicals’ com bined DTPa-IPV/Hib (Infanrix™-IPV+Hib) and HBV (Engerix-B™ Kinder) vaccines administered concomitantly in separate injections to children previously primed with licensed vaccines according to the vaccination recommendations currently in place in Germany.
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:
Saenger R et al. (2005) Booster vaccination with hexavalent DTPa-HBV-IPV/Hib vaccine in the second year of life is as safe as concomitant DTPa-IPV/Hib + HBV administered separately. Vaccine. 23: 1135–1143.
Medical condition
Hepatitis B
Product
Hepatitis B Vaccine, Recombinant
Collaborators
Not applicable
Study date(s)
September 2000 to July 2001
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
2001-25-07
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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Access to clinical trial data by researchers
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