Last updated: 11/29/2018 16:20:34
A phase III, double-blind, randomized, multicenter primary vaccination study to bridge the DTPa-HBV-IPV vaccine manufactured according to the large scale manufacturing process with the DTPa-HBV-IPV vaccine manufactured by the small scale manufacturing process when administered intramuscularly to infants at 2, 4 and 6 months of age, co-administered with Merck's Hib conjugate vaccine (Liquid PedvaxHIB®) in a separate injection at 2 and 4 months of age
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, double-blind, randomized, multicenter primary vaccination study to bridge the DTPa-HBV-IPV vaccine manufactured according to the large scale manufacturing process with the DTPa-HBV-IPV vaccine manufactured by the small scale manufacturing process when administered intramuscularly to infants at 2, 4 and 6 months of age, co-administered with Merck's Hib conjugate vaccine (Liquid PedvaxHIB®) in a separate injection at 2 and 4 months of age
Trial description: A phase III, double-blind, randomized, multicenter primary vaccination study to bridge the DTPa-HBV-IPV vaccine manufactured according to the large scale manufacturing process with the DTPa-HBV-IPV vaccine manufactured by the small scale manufacturing process when administered intramuscularly to infants at 2, 4 and 6 months of age, co-administered with Merck's Hib conjugate vaccine (Liquid PedvaxHIB®) in a separate injection at 2 and 4 months of age
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:
Nolan et al. (2007) DTPa-HBV-IPV vaccine for primary vaccination of infants. J Pediatrics and Child Health 43:587-592.
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 2001 to April 2002
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
2002-02-04
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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