Trials / Completed
CompletedNCT01457508
Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib, Compared to DTPa-HBV-IPV and Hib Administered Separately
Study to Assess the Immunogenicity and Reactogenicity of DTPa-HBV-IPV Vaccine Mixed With Hib Vaccine to Healthy Infants at 3, 5 and 11 Months of Age, Compared to Each Vaccine Administered Separately
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 440 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 12 Weeks – 16 Weeks
- Healthy volunteers
- Accepted
Summary
This study will assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals' (formerly SB Biologicals') DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine compared with separate administration of DTPa-HBV-IPV (Infanrix penta™) and Hib (Hiberix™) vaccine administered at 3, 5 and 11 (or 12) months of age.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | DTPa-HBV-IPV/Hib (Infanrix hexa™) | Three doses administered intramuscularly |
| BIOLOGICAL | DTPa-HBV-IPV (Infanrix penta™) | Three doses administered intramuscularly |
| BIOLOGICAL | Hib (Hiberix™) | Three doses administered intramuscularly |
Timeline
- Start date
- 1999-01-01
- Primary completion
- 2000-03-01
- Completion
- 2000-03-01
- First posted
- 2011-10-24
- Last updated
- 2017-06-16
Source: ClinicalTrials.gov record NCT01457508. Inclusion in this directory is not an endorsement.