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Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Infants

NCT00779779 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 522

Last updated 2018-08-28

Study results available
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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

  • Infections, Rotavirus

Interventions

BIOLOGICAL

Rotarix™

Two oral doses, with at least 4 weeks interval in-between

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Eligibility

Min Age
6 Weeks
Max Age
19 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-11-22
Primary Completion
2009-05-25
Completion
2009-08-26

Countries

  • Sri Lanka

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00779779 on ClinicalTrials.gov