Intussusception Surveillance After Rotarix Introduction in Mexico

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00595205
Recruitment Status : Completed
First Posted : January 16, 2008
Last Update Posted : March 19, 2012
Information provided by (Responsible Party):

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™.

Condition or disease Intervention/treatment
Intussusception (IS) Rotavirus Vaccines Other: Hospital log review.

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.

Study Type : Observational
Actual Enrollment : 786 participants
Time Perspective: Prospective
Official 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
Study Start Date : January 2008
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Group IS
Subjects <1 year of age with definite intussusception cases who had received Rotarix™.
Other: Hospital log review.
Reviewing of the hospital log to monitor for the occurrence of intussusception.

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

Secondary Outcome Measures :
  1. Occurrence of definite IS episodes within Day 0 to Day 15 following vaccination [ Time Frame: Day 0 to Day 15 post Rotarix vaccination ]
  2. Yearly occurrence of definite IS episodes (regardless of vaccination status) [ Time Frame: Assessed for the interim analysis and after study conclusion ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 364 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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 <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
  • 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:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00595205

GSK Investigational Site
Mexico Df, Mexico, 06720
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline

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.

Responsible Party: GlaxoSmithKline Identifier: NCT00595205     History of Changes
Other Study ID Numbers: 104435
First Posted: January 16, 2008    Key Record Dates
Last Update Posted: March 19, 2012
Last Verified: February 2011

Keywords provided by GlaxoSmithKline:

Additional relevant MeSH terms:
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases