Trials / Completed
CompletedNCT00757770
Assessment of Clinical Consistency of Three Production Lots of GSK Biologicals' HRV Vaccine
Study to Assess the Clinical Consistency of Three Production Lots of GSK Biologicals' HRV Vaccine in Terms of Immunogenicity and Safety When Given to Healthy Infants at 2 and 4 Months of Age
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 854 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 6 Weeks – 12 Weeks
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to evaluate the lot-to-lot consistency of three production lots of GSK Biologicals' HRV vaccine in terms of immunogenicity and safety in healthy infants aged 2 months at the time of first vaccination.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Rotarix | Two oral doses. |
| BIOLOGICAL | Placebo | Two oral doses; The placebo consist of all components of the study vaccine i.e. excipients and buffer, but no RV particles. |
Timeline
- Start date
- 2003-08-01
- Primary completion
- 2004-01-01
- Completion
- 2004-01-01
- First posted
- 2008-09-23
- Last updated
- 2016-09-07
Locations
4 sites across 3 countries: Colombia, Mexico, Peru
Source: ClinicalTrials.gov record NCT00757770. Inclusion in this directory is not an endorsement.