Last updated: 08/14/2019 20:30:35
A phase III multicenter, randomized, controlled primary vaccination study to assess the lot-to-lot consistency of the production method of SB Biologicals' DTPa-HBV-IPV and Hib conjugate vaccines when mixed extemporaneously and given in a single injection, and compared in terms of safety to commercially available vaccines in healthy infants.
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 multicenter, randomized, controlled primary vaccination study to assess the lot-to-lot consistency of the production method of SB Biologicals' DTPa-HBV-IPV and Hib conjugate vaccines when mixed extemporaneously and given in a single injection, and compared in terms of safety to commercially available vaccines in healthy infants.
Trial description: A phase III multicenter, randomized, controlled primary vaccination study to assess the lot-to-lot consistency of the production method of SB Biologicals' DTPa-HBV-IPV and Hib conjugate vaccines when mixed extemporaneously and given in a single injection, and compared in terms of safety to commercially available vaccines in healthy infants.
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:
Not applicable
Medical condition
Diphtheria, Tetanus, Pertussis, Hepatitis B, polio, Haemophilus influenzae type b
Product
DTPa-HBV-IPV
Collaborators
Not applicable
Study date(s)
July 1998 to March 1999
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
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
1999-25-03
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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