Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Indian Infants
NCT00938327 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 332
Last updated 2018-01-02
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
- Infections, Rotavirus
Interventions
- BIOLOGICAL
-
Rotarix™
Two doses of oral vaccine.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
GSK Clinical Trials · GlaxoSmithKline
Eligibility
- Min Age
- 6 Weeks
- Max Age
- 167 Days
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2009-08-03
- Primary Completion
- 2010-02-20
- Completion
- 2010-04-23
Countries
- India
Study Locations
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