Trials / Completed
CompletedNCT00696423
Immunogenicity and Safety of GSK Biologicals' Infanrix/Hib in Children
Immunogenicity and Reactogenicity Study of GlaxoSmithKline Biologicals' Infanrix™/Hib Vaccine Administered as a Booster Dose to 18-24 Months Old Children
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 467 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Months – 24 Months
- Healthy volunteers
- Accepted
Summary
This protocol posting deals with objectives \& outcome measures of the booster phase. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00412854). This Phase IIIB study will compare GSK Biologicals' DTPa/Hib vaccine to separately administered DTPa and Hib vaccines in Chinese children 18 to 24 months of age, in terms of safety and immunogenicity.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Infanrix™ | Intramuscular injection, one dose |
| BIOLOGICAL | Hiberix™ | Intramuscular injection, one dose |
Timeline
- Start date
- 2008-06-07
- Primary completion
- 2008-07-26
- Completion
- 2008-07-26
- First posted
- 2008-06-12
- Last updated
- 2018-06-06
- Results posted
- 2009-08-26
Locations
3 sites across 1 country: China
Source: ClinicalTrials.gov record NCT00696423. Inclusion in this directory is not an endorsement.