Trials / Completed
CompletedNCT00938327
Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Indian Infants
Post Marketing Surveillance to Monitor the Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Human Rotavirus Vaccine, Rotarix™ When Administered According to the Prescribing Information to Indian Infants
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 332 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 6 Weeks – 167 Days
- Healthy volunteers
- Accepted
Summary
This post marketing surveillance will evaluate reactogenicity and safety data of human rotavirus vaccine when administered to healthy infants according to the Prescribing Information in India.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Rotarix™ | Two doses of oral vaccine. |
Timeline
- Start date
- 2009-08-03
- Primary completion
- 2010-02-20
- Completion
- 2010-04-23
- First posted
- 2009-07-13
- Last updated
- 2018-01-02
- Results posted
- 2011-03-16
Locations
12 sites across 1 country: India
Source: ClinicalTrials.gov record NCT00938327. Inclusion in this directory is not an endorsement.