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Intussusception Surveillance After Rotarix Introduction in Mexico

NCT00595205 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 786

Last updated 2012-03-19

No results posted yet for this study

Summary

GSK Biologicals' rotavirus vaccine, Rotarix™ has been recommended for universal use targeting infants through the Expanded Program on Immunization (EPI) in Mexico. This protocol describes a Phase IV safety study in Mexico designed to further evaluate the safety profile of Rotarix™ with regard to intussusception (IS). The data generated by this study will be useful for public health officers and policy makers in confirming the safety profile of Rotarix™.

Conditions

  • Intussusception (IS)
  • Rotavirus Vaccines

Interventions

OTHER

Hospital log review.

Reviewing of the hospital log to monitor for the occurrence of intussusception.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Eligibility

Max Age
364 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • Mexico

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 NCT00595205 on ClinicalTrials.gov