Trials / Completed
CompletedNCT00325156
Assess the Safety & Reactogenicity of DTPa-IPV/Hib Vaccine Administered at 3, 4, 5 & 18 Mths of Age, in Healthy Infants
An Open, Multicentric, Post-marketing Surveillance Study to Assess the Safety and Reactogenicity of GlaxoSmithKline Biologicals' DTPa-IPV/Hib Vaccine Administered at 3, 4, 5 and 18 Months of Age, in Healthy Infants.
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 2,590 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 11 Weeks – 17 Weeks
- Healthy volunteers
- Accepted
Summary
To assess the safety and reactogenicity of the DTPa-IPV/Hib vaccine as primary and booster vaccination. The DTPa-IPV/Hib vaccine given at 3 and 4 months of age is co-administered with GSK Biologicals' rotavirus vaccine or Placebo. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Detailed description
Single group study. Subjects in GSK Biologicals' rotavirus study (Rota-028) in Singapore will be enrolled in this study. 3-4-5 month schedule with a booster dose at 18 months
Conditions
- Diphtheria
- Tetanus
- Poliomyelitis
- Acellular Pertussis
- Haemophilus Influenzae Type b
- Diphtheria-Tetanus-aPertussis-Poliomyelitis Vaccines
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | GSK Biologicals' combined DTPa-IPV/Hib vaccine | 4 intramuscular injections |
Timeline
- Start date
- 2004-11-02
- Primary completion
- 2007-08-23
- Completion
- 2007-08-23
- First posted
- 2006-05-12
- Last updated
- 2020-01-02
- Results posted
- 2017-02-07
Locations
1 site across 1 country: Singapore
Source: ClinicalTrials.gov record NCT00325156. Inclusion in this directory is not an endorsement.