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To Evaluate Safety & Reactogenicity of GSK Bio's Human Rotavirus (HRV) Vaccine in Filipino Infants at Least 6 Weeks of Age at First Vaccination

NCT00353366 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1439

Last updated 2021-03-16

Study results available
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Summary

GSK has submitted a registration file for its live attenuated oral human rotavirus (HRV) vaccine in several countries. In view of its registration in the Philippines, the present study will collect data on the safety of the vaccine in the local target population as per the Bureau of Food and Drugs Directive.

Conditions

  • Infections, Rotavirus
  • Rotavirus Vaccines

Interventions

BIOLOGICAL

Rotarix

Two doses of the oral vaccine

OTHER

Data collection

Safety evaluation: recording of adverse events by using diary cards and by non-leading questioning.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Eligibility

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

Timeline & Regulatory

Start
2006-11-16
Primary Completion
2010-03-31
Completion
2010-07-17

Countries

  • Philippines

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 NCT00353366 on ClinicalTrials.gov