Trials / Completed
CompletedNCT00779779
Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Infants
Reactogenicity and Safety of Two Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus Vaccine, Rotarix™ When Administered in Sri Lankan Infants Aged at Least 6 Weeks at the Time of First Vaccination.
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 522 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 6 Weeks – 19 Weeks
- Healthy volunteers
- Accepted
Summary
This Post Marketing Surveillance (PMS) will collect reactogenicity and safety data on the use of human rotavirus vaccine in healthy infants aged from 6 weeks (first dose) to not more than 24 weeks (second dose).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Rotarix™ | Two oral doses, with at least 4 weeks interval in-between |
Timeline
- Start date
- 2008-11-22
- Primary completion
- 2009-05-25
- Completion
- 2009-08-26
- First posted
- 2008-10-24
- Last updated
- 2018-08-28
- Results posted
- 2010-07-30
Locations
1 site across 1 country: Sri Lanka
Source: ClinicalTrials.gov record NCT00779779. Inclusion in this directory is not an endorsement.