Last updated: 11/20/2018 16:10:18
A phase III, open, multicenter study of the safety and immunogenicity of a booster dose of SmithKline Beecham Biologicals’ Diphtheria and Tetanus toxoids and acellular Pertussis (DTaP) vaccine (Infanrix™) and Pasteur Mérieux’s Haemophilus influenzae type b (Hib) conjugate vaccine (OmniHIB®) when administered intramuscularly as separate injections between 12 and 18 months of age following primary immunization at 2 months, 4 months, and 6 months of age in study DTPa-HBV-IPV-027 (217744/027)
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, open, multicenter study of the safety and immunogenicity of a booster dose of SmithKline Beecham Biologicals’ Diphtheria and Tetanus toxoids and acellular Pertussis (DTaP) vaccine (Infanrix™) and Pasteur Mérieux’s Haemophilus influenzae type b (Hib) conjugate vaccine (OmniHIB®) when administered intramuscularly as separate injections between 12 and 18 months of age following primary immunization at 2 months, 4 months, and 6 months of age in study DTPa-HBV-IPV-027 (217744/027)
Trial description: A phase III, open, multicenter study of the safety and immunogenicity of a booster dose of SmithKline Beecham Biologicals’ Diphtheria and Tetanus toxoids and acellular Pertussis (DTaP) vaccine (Infanrix™) and Pasteur Mérieux’s Haemophilus influenzae type b (Hib) conjugate vaccine (OmniHIB®) when administered intramuscularly as separate injections between 12 and 18 months of age following primary immunization at 2 months, 4 months, and 6 months of age in study DTPa-HBV-IPV-027 (217744/027)
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:
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Medical condition
Diphtheria, Tetanus, acellular pertussis
Product
Diphtheria, Tetanus, Acellular Pertussis Vaccine Adsorbed
Collaborators
Not applicable
Study date(s)
November 1999 to May 2000
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
2000-31-05
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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