Last updated: 11/29/2018 16:00:31
A phase II, single-blinded, randomized comparative study of the safety and immunogenicity of a booster dose of SmithKline Beecham Biologicals' DTPa-HBV-IPV vaccine compared with Infanrix™ when both vaccines are co-administered with OmniHIB™ between 15 and 18 months of age following primary immunization at the age of 2, 4 and 6 months in the study DTPa-HBV-IPV-044 (217744/044)
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 II, single-blinded, randomized comparative study of the safety and immunogenicity of a booster dose of SmithKline Beecham Biologicals' DTPa-HBV-IPV vaccine compared with Infanrix™ when both vaccines are co-administered with OmniHIB™ between 15 and 18 months of age following primary immunization at the age of 2, 4 and 6 months in the study DTPa-HBV-IPV-044 (217744/044)
Trial description: A phase II, single-blinded, randomized comparative study of the safety and immunogenicity of a booster dose of SmithKline Beecham Biologicals' DTPa-HBV-IPV vaccine compared with Infanrix™ when both vaccines are co-administered with OmniHIB™ between 15 and 18 months of age following primary immunization at the age of 2, 4 and 6 months in the study DTPa-HBV-IPV-044 (217744/044)
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, 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)
May 1999 to November 1999
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
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
1999-29-11
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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