Study identification

PURI

https://redirect.ema.europa.eu/resource/31671

EU PAS number

EUPAS6103

Study ID

31671

Official title and acronym

104435 - Post-Authorization Safety Study (PASS) of Post-Marketing Surveillance for Intussusception Following Rotarix Introduction into the Instituto Mexicano del Seguro Social (IMSS) in Mexico

DARWIN EU® study

No

Study countries

Mexico

Study description

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.This is a post marketing, Phase IV, observational, prospective, self-controlled case series, vaccine safety study including:a) active hospital-based surveillance, conducted in approximately 60 to 90 IMSS health facilities with pediatric surgery service, to identify all definite IS cases in children younger than one year of age among IMSS members,b) a self-controlled case series (SCCS) design/analysis to assess the temporal association with Rotarix of the IS ascertained through active surveillance.

Study status

Finalised
Research institutions and networks

Institutions

Medical Research Unit on Infectious Diseases, Paediatrics Hospital, National Medical Centre-Century XXI, IMSS

Contact details

Call Center EU Clinical Trials

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Date of final study report

Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline Biologicals
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)