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Study ID	104435
Clinical Study ID	104435
Study 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
Clinicaltrials.gov Identifier	NCT00595205
Sponsor	GlaxoSmithKline
Collaborators	N/A
Phase	phase 4
Study Recruitment Status	Completed
Generic Name	Rotavirus Vaccine
Trade Name	BIO ROTA; Rotarix
Study Indication	Infections, Rotavirus

First Received

Last Updated

Acronym
Secondary IDs
FDA Regulated Intervention?	No
Section 801 Clinical Trial
Delayed Posting
IND/IDE Protocol	no
IND/IDE Grantor
IND/IDE Number
IND/IDE Serial Number
Has Expanded Access
Study Type	Observational
Oversight Authority	Mexico:Instituto Mexicano del Seguro Social (IMSS)
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 Description	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 to identify all definite IS cases in children younger than one year of age (children ineligible on day of first birthday) among IMSS members. Surveillance will be conducted in approximately 60 to 90 IMSS health facilities with pediatric surgery service. Study participation for children fitting the surveillance case definition of IS will include parental/guardian/legal representative interview, as well as a review of medical charts and vaccination records. Additional medical information will be collected through medical record review during hospitalization and after the child has been discharged.
Record Verification Date	February 01, 2011
Why Study Stopped
Study Start Date	January 2008
Study Completion Date	October 2010
Study Completion Date Type	Actual
Primary Completion Date	October 2010
Primary Completion Date Type	Actual
Study Design	Other
Time Perspective	Prospective
Biospecimen Retention	None retained
Biospecimen Description	not applicable
Is Patient Registry
Target Duration Quantity
Target Duration Units
Primary Outcomes	Occurrence of definite IS episodes within Day 0 to Day 30 following vaccination Time Frame: 0- 30 days following Rotarix vaccination Safety Issue: No
Secondary Outcomes	Yearly occurrence of definite IS episodes (regardless of vaccination status) Time Frame: Assessed for the interim analysis and after study conclusion Safety Issue: No Occurrence of definite IS episodes within Day 0 to Day 15 following vaccination Time Frame: Day 0 to Day 15 post Rotarix vaccination Safety Issue: No
Arms	Group IS Subjects <1 year of age with definite intussusception cases who had received Rotarix™.
Interventions	Hospital log review. Type: other Description: Reviewing of the hospital log to monitor for the occurrence of intussusception. Arms: Group IS
Keywords	vaccination intussusception Rotavirus vaccine
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.
Sampling Method	Non probability
Eligibility Criteria:	Click to view 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 • 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
Gender	Both
Minimum Age
Maximum Age	364 Days
Enrollment	786
Enrollment Type	Actual
Healthy Volunteers	none
Central Contact	Call Center
Central Contact Phone	877-379-3718
Central Contact Email	GSKClinicalSupportHD@gsk.com
Overall Study Official	GSK Clinical Trials
Overall Study Official Affiliation	GlaxoSmithKline
Overall Study Official Role	Study Director

Document Title	First Received	Last Updated
Click here to view result summary	Dec 02, 2010	Sep 18, 2014

Document Title	First Received	Last Updated
gsk-104435-protocol-redact-v02.pdf	Oct 09, 2014	Oct 26, 2016

Document Title	First Received	Last Updated
gsk-104435-clinical-study-report-redact-v02.pdf Large documents may take several minutes to open.	Nov 05, 2015	Oct 26, 2016

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104435

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