Last updated: 04/21/2020 13:20:05
Open, randomised clinical study to assess the immunogenicity and reactogenicity of SB Biologicals’ DTPa-HBV-IPV and Hib vaccines administered as a single injection, compared to SB Biologicals’ DTPa-HBV-IPV and Hib vaccines administered separately into opposite limbs, as a three-dose primary vaccination course during the 3rd, 4th and 5th month 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: Open, randomised clinical study to assess the immunogenicity and reactogenicity of SB Biologicals’ DTPa-HBV-IPV and Hib vaccines administered as a single injection, compared to SB Biologicals’ DTPa-HBV-IPV and Hib vaccines administered separately into opposite limbs, as a three-dose primary vaccination course during the 3rd, 4th and 5th month of life.
Trial description: Open, randomised clinical study to assess the immunogenicity and reactogenicity of SB Biologicals’ DTPa-HBV-IPV and Hib vaccines administered as a single injection, compared to SB Biologicals’ DTPa-HBV-IPV and Hib vaccines administered separately into opposite limbs, as a three-dose primary vaccination course during the 3rd, 4th and 5th month 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:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Diphtheria, Tetanus, Pertussis, Hepatitis B, Poliomyelitis, Haemophilus influenzae type b
Product
SB Biologicals’ DTPa?HBV?IPV and Hib vaccines
Collaborators
Not applicable
Study date(s)
October 1997 to October 1998
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
1998-02-10
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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