Intussusception Surveillance After Rotarix Introduction in Mexico

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00595205
• Date of registration: 04/01/2008
• Prospective Registration: No
• Primary sponsor: GlaxoSmithKline
• Public title: Intussusception Surveillance After Rotarix Introduction in Mexico
• Scientific title: Post-Authorization Safety Study (PASS) of Post-Marketing Surveillance for Intussusception Following Rotarix™ Introduction Into the Instituto Mexicano Del Seguro Social (IMSS) in Mexico
• Date of first enrolment: January 2008
• Target sample size: 786
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00595205
• Study type: Observational
• Study design: Time Perspective: Prospective
• Phase: N/A

Countries of recruitment

Mexico

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion criteria

Inclusion Criteria:

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 becomes ineligible on the day of their first birthday)

- Subject is diagnosed with definite IS based on the Brighton criteria

- Written informed consent is obtained from the parent/guardian/legal representative of
the subject Subjects meeting the above criteria will be eligible for inclusion in
this study regardless of whether or not the subject has had a radiographically or
surgically confirmed case of IS prior to the current episode.

Exclusion Criteria:

Not applicable



Age minimum: N/A
Age maximum: 364 Days
Gender: Both

Health Condition(s) or Problem(s) studied

Rotavirus Vaccines

Intussusception (IS)

Intervention(s)

Other: Hospital log review.

Primary Outcome(s)

Occurrence of definite IS episodes within Day 0 to Day 30 following vaccination [Time Frame: 0- 30 days following Rotarix vaccination]

Secondary Outcome(s)

Occurrence of definite IS episodes within Day 0 to Day 15 following vaccination [Time Frame: Day 0 to Day 15 post Rotarix vaccination]

Yearly occurrence of definite IS episodes (regardless of vaccination status) [Time Frame: Assessed for the interim analysis and after study conclusion]

Secondary ID(s)

104435

Source(s) of Monetary Support

Please refer to primary and secondary sponsors