Intussusception Surveillance After Rotarix Introduction in Mexico

NCT00595205 | Completed

• 1 other identifier: 104435
• Study Type: observational
• Target: 786
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

vaccination; intussusception; Rotavirus; vaccine

Outcome Measures

Primary Outcomes (1)

• Occurrence of definite IS episodes within Day 0 to Day 30 following vaccination

  0- 30 days following Rotarix vaccination

Secondary Outcomes (2)

• Occurrence of definite IS episodes within Day 0 to Day 15 following vaccination

  Day 0 to Day 15 post Rotarix vaccination

• Yearly occurrence of definite IS episodes (regardless of vaccination status)

  Assessed for the interim analysis and after study conclusion

Study Arms (1)

Group IS

Subjects \<1 year of age with definite intussusception cases who had received Rotarix™.

Other: Hospital log review.

Interventions

Hospital log review. OTHER

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

Group IS

Eligibility Criteria

• Age: Up to 364 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All eligible children \< 1 year of age (children ineligible on day of first birthday) who are/have been treated at one of the study hospitals/medical facilities with definite intussusception.

You may qualify if:

• A child's clinical episode will be defined as an IS case and deemed eligible for the study if he/she meets the following criteria:
• Subject is an IMSS affiliate
• Subject is being treated/has been treated/has been referred for treatment at one of the IMSS hospitals/medical facilities with IS during the study period.
• Male or female child is \<one year of age at the time of diagnosis of the IS (child becomes ineligible on the day of their first birthday)
• Subject is diagnosed with definite IS based on the Brighton criteria

You may not qualify if:

• Not applicable

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Mexico City, 06720, Mexico

Location

Related Publications (1)

• Velázquez FR et al. Postmarketing surveillance to assess risk of intussusception following introduction of the G1P[8] human rotavirus vaccine in Mexico. Abstract presented at the Excellence in Paediatrics (EXPE). London, UK, 2-4 December 2010.

  BACKGROUND

MeSH Terms

Conditions

Intussusception

Condition Hierarchy (Ancestors)

Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2008
• First Posted: January 16, 2008
• Study Start: January 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: March 19, 2012

Record last verified: 2011-02

Locations

ME (1)