Clinical Trial: Intussusception Surveillance After Rotarix Introduction in Mexico
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Post-Authorization Safety Study (PASS) of Post-Marketing Surveillance for Intussusception Following Rotarix™ Introduction Into the Instituto Mexicano Del Seguro Soci
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™.
Detailed Summary:
Rationale for amendment 3:
The findings from the first year of the implementation of the active surveillance showed that most Lower Respiratory Tract-Related Post-Neonatal (LRTI) Mortality cases could not be included into the study, because most of the grieving parents refused to participate in the study. The European Medicines Agency Marketing Authorization Holders (EMEA MAH) also generated a substantial amount of additional clinical and post-marketing safety data throughout the world, which clearly indicated the absence of any safety signal when considering the LTRI-related fatalities. Therefore surveillance for LRTI mortality cases was removed from the study design. The number of sites was reduced from approximately 230 to about 60 to 90 in order to reflect the above mentioned change that reduced the need for so many sites. Additionally, passive surveillance for IS cases through the IMSS database was not feasible, due to restrictions of the IMSS internal policies and to the current limitations in the databases linkage and structure abilities.
Lastly, SAEs reporting procedures had to be adjusted according to the Council for International Organizations of Medical Sciences (CIOMS) Working Group V, 2001 publication such that there will be no expedited safety reporting for this study.
Design This is a post marketing ,Phase IV, observational, prospective, self-controlled case series, vaccine safety study including: a) hospital-based surveillance to monitor for the occurrence of IS through active surveillance; b) a self-controlled case series (SCCS) design/analysis to assess the temporal association with Rotarix™ of the IS ascertained through active surveillance.
The aim of the active hospital-based surveillance system is
Sponsor: GlaxoSmithKline
Current Primary Outcome: Occurrence of definite IS episodes within Day 0 to Day 30 following vaccination [ Time Frame: 0- 30 days following Rotarix vaccination ]
Original Primary Outcome: Assess the occurrence of definite IS following vaccination [ Time Frame: Within 31 days following Rotarix vaccination ]
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Occurrence of LRTI-related post-neonatal deaths [ Time Frame: Up to 31 days after Rotarix vaccination and of IS within 16 days after vaccination ]
Information By: GlaxoSmithKline
Dates:
Date Received: January 4, 2008
Date Started: January 2008
Date Completion:
Last Updated: March 15, 2012
Last Verified: February 2011
