Last updated: 11/07/2018 13:10:54
Immunogenicity and reactogenicity study of GSK’s combined diphtheria, tetanus, acellular pertussis, inactivated polio vaccine, coadministered with GSK’s Haemophilus influenzae type b conjugate vaccine, either in 2 concomitant injections or mixed in one injection, given to healthy infants at 2, 4 and 6 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: Immunogenicity and reactogenicity study of GSK’s combined diphtheria, tetanus, acellular pertussis, inactivated polio vaccine, coadministered with GSK’s Haemophilus influenzae type b conjugate vaccine, either in 2 concomitant injections or mixed in one injection, given to healthy infants at 2, 4 and 6 months
Trial description: Immunogenicity and reactogenicity study of GSK’s combined diphtheria, tetanus, acellular pertussis, inactivated polio vaccine, coadministered with GSK’s Haemophilus influenzae type b conjugate vaccine, either in 2 concomitant injections or mixed in one injection, given to healthy infants at 2, 4 and 6 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:
Halperin SA et al. (1999) Safety and immunogenicity of Haemophilus influenzae-tetanus toxoid conjugate vaccine given separately or in combination with a three-component acellular pertussis vaccine combined with diphtheria and tetanus toxoids and inactivated poliovirus vaccine for the first four doses. Clin Infect Dis. 28(5):995-1001.
Medical condition
Haemophilus influenzae type b
Product
Haemophilus influenzae Type b Vaccine
Collaborators
Not applicable
Study date(s)
July 1994 to June 1995
Type
Not applicable
Phase
2
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
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
1995-30-06
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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