Trials / Completed
CompletedNCT00908115
Post Market Surveillance for Infanrix™
Evaluation of Safety and Efficacy Through Post Market Surveillance for Infanrix™, the DTaP Mixed Vaccine
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,258 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The purpose of this study was to investigate the following questions through post-marketing surveillance: * Unknown/Unexpected adverse events and the serious adverse events. * The circumstances in which the adverse events occurred under the practical application. * Factors considered to have influence on safety. * Factors considered to have influence on efficacy. * Miscellaneous - Facts about mechanism, efficacy and safety which were not clearly known due to the inherent problems of the drugs.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | GSK Biologicals' Infanrix™ | Primary and booster vaccination according to vaccination schedule. Intramuscular injection |
Timeline
- Start date
- 2003-08-01
- Primary completion
- 2008-06-23
- Completion
- 2008-06-23
- First posted
- 2009-05-25
- Last updated
- 2020-01-02
- Results posted
- 2009-07-17
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT00908115. Inclusion in this directory is not an endorsement.