Last updated: 04/21/2020 13:00:06
Randomised clinical study to assess the safety and reactogenicity of SB Biologicals' DTPa-HBV-IPV vaccine, when co-administered with Hib vaccine in two concomitant injections into opposite limbs, as a primary vaccination course to healthy infants at the age of 3, 4 and 5 months
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Randomised clinical study to assess the safety and reactogenicity of SB Biologicals' DTPa-HBV-IPV vaccine, when co-administered with Hib vaccine in two concomitant injections into opposite limbs, as a primary vaccination course to healthy infants at the age of 3, 4 and 5 months
Trial description: Randomised clinical study to assess the safety and reactogenicity of SB Biologicals' DTPa-HBV-IPV vaccine, when co-administered with Hib vaccine in two concomitant injections into opposite limbs, as a primary vaccination course to healthy infants at the age of 3, 4 and 5 months
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:
Zepp F, Schuind A, Meyer C, et al. Safety and reactogenicity of a novel DTPa-HBV-IPV combined vaccine given along with commercial Hib vaccines in comparison with separate concomitant administration of DTPa, Hib, and OPV vaccines in infants. PEDIATRICS. 2002; 109(4):e58.
Medical condition
Diphtheria, Hepatitis B, Poliomyelitis, Tetanus, acellular pertussis
Product
Combined Diphtheria, Tetanus, Acellular Pertussis Adsorbed, Hepatitis B (Recombinant), Inactivated Polio Vaccine
Collaborators
Not applicable
Study date(s)
November 1995 to January 1998
Type
Interventional
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
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
1998-15-01
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
Additional information
Not applicable
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Access to clinical trial data by researchers
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