Last updated: 11/29/2018 23:30:21
A multinational, randomised, controlled, single-blind, phase-II study to evaluate the safety and immunogenicity of two investigational vaccination regimens versus a licensed Haemophilus influenzae type b (Hib) conjugate vaccine (Hiberix) given concomitantly with DTPw-HBV vaccine in a separate injection of DTPw-HBV to infants at 2, 4, and 6 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 multinational, randomised, controlled, single-blind, phase-II study to evaluate the safety and immunogenicity of two investigational vaccination regimens versus a licensed Haemophilus influenzae type b (Hib) conjugate vaccine (Hiberix) given concomitantly with DTPw-HBV vaccine in a separate injection of DTPw-HBV to infants at 2, 4, and 6 months of age
Trial description: A multinational, randomised, controlled, single-blind, phase-II study to evaluate the safety and immunogenicity of two investigational vaccination regimens versus a licensed Haemophilus influenzae type b (Hib) conjugate vaccine (Hiberix) given concomitantly with DTPw-HBV vaccine in a separate injection of DTPw-HBV to infants at 2, 4, and 6 months of age
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
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Interventions:
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Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
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Time perspective:
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Clinical publications:
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Medical condition
Diphtheria, Hepatitis B, Tetanus, Whole Cell Pertussis
Product
Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B Vaccine
Collaborators
Not applicable
Study date(s)
August 2000 to March 2001
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
2001-21-03
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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