Last updated: 11/07/2018 00:18:21
Assess safety & reactogenicity of GSK Biologicals' Hib vaccine co-administered with or without Chinese DTPw vaccine
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Assess the safety & reactogenicity of GSK Biologicals Hib vaccine co-administered with Chinese local DTPw vaccine when compared to Chinese local DTPw vaccine administered alone, in healthy infants at 3,4 & 5 mths of age
Trial description: To assess safety and reactogenicity of GSK Biologicals' Haemophilus influenza type b vaccine co-administered with or without Chinese DTPw vaccine administered alone in healthy infants (3, 4 and 5 months of age)
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
454
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Feng-xiang Li et al. (2008) Safety and reactogenicity of Hib tetanus conjugate vaccine when coadministered with DTPw vaccine in infants at 3, 4 and 5 months of age. 21(9):803-805.
Medical condition
Haemophilus influenzae type b disease
Product
SB208108
Collaborators
Not applicable
Study date(s)
January 2005 to July 2005
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
3 - 4 months
Accepts healthy volunteers
Yes
- A male or female infant between, and including, 11 and 17 weeks of age at the time of the first vaccination.
- Planned administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the first vaccine dose and ending 30 days after the last dose.
- Chronic administration of immunosuppressants or other immune-modifying drugs from birth until administration of first dose of study vaccine.
Inclusion and exclusion criteria
Inclusion criteria:
- A male or female infant between, and including, 11 and 17 weeks of age at the time of the first vaccination.
Exclusion criteria:
- Planned administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the first vaccine dose and ending 30 days after the last dose.
- Chronic administration of immunosuppressants or other immune-modifying drugs from birth until administration of first dose of study vaccine.
- Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2005-28-07
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
Additional information
Not applicable
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