Intussusception and Lower Respiratory Tract-Related Infant Mortality Surveillance After Rotarix Introduction in Mexico - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00595205

Purpose

GSK Biologicals' rotavirus vaccine, Rotarix™ has been recommended for universal use targeting infants through the EPI in Mexico. This protocol describes a safety study in Mexico designed to further evaluate the safety profile of Rotarix™ with regard to intussusception (IS) and lower respiratory tract infection (LRTI)-related post-neonatal infant deaths. The data generated by this study will be useful for public health officers and policy makers in confirming the safety profile of Rotarix™.

Condition	Intervention
Intussusception LRTI-Related Post Neonatal Deaths	Biological: No intervention

Drug Information available for: RotaTeq

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	Post-Marketing Surveillance for Intussusception and Lower Respiratory Tract-Related Post-Neonatal Mortality Following Rotarix Introduction Into the IMSS (Instituto Mexicano Del Seguro Social) in Mexico

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Assess the occurrence of definite IS following vaccination [ Time Frame: Within 31 days following Rotarix vaccination ]

Secondary Outcome Measures:

Occurrence of LRTI-related post-neonatal deaths [ Time Frame: Up to 31 days after Rotarix vaccination and of IS within 16 days after vaccination ]

Estimated Enrollment:	860
Study Start Date:	January 2008
Estimated Study Completion Date:	December 2010

Detailed Description:

This is a post marketing surveillance Phase IV, prospective, hospital-based, vaccine safety study including hospital-based surveillance to monitor for the occurrence of IS and post-neonatal LRTI-related deaths through both active surveillance (hospital log review, IMSS data review) and passive surveillance (IMSS database review). A self-controlled case series (SCCS) design/analysis will be used to assess the temporal association with Rotarix™ of the IS and deaths ascertained through active surveillance.

Active Hospital-Based Surveillance for IS and Post-Neonatal LRTI-related deaths Among Children under 1 Year of Age:

The aim of the active hospital-based surveillance system is to identify all IS cases in children younger than one year of age and all post-neonatal LRTI-related deaths among children between 29 days (inclusive) and one year of age (children ineligible on day of first birthday) among IMSS members.

Surveillance will be conducted in approximately 230 IMSS health facilities with pediatric medical care.

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, vaccination records and limited demographic information from the IMSS database. Additional medical information will be collected through medical record review during hospitalization and after the child has been discharged. Study staff at each hospital will perform weekly review of hospital morgue records for LRTI-related deaths in children between 29 days (inclusive) and one year of age (children ineligible on first birthday). Study staff will contact the parents/guardians/legal representative of the deceased child to explain the study and request enrollment. All definite IS cases and LRTI-related post-neonatal deaths will be recorded.

Passive Hospital-Based Surveillance for IS and Post-Neonatal LRTI-Related Deaths Among Children under 1 Year of Age:

A central Information Coordinator (IMSS staff member) will perform systematic, automated, monthly reviews of the IMSS database (electronic files of immunizations, outpatient visits, hospitalizations, mortality surveillance, and radiology-imagery reports) to identify post-neonatal LRTI-related deaths and any IS cases that were not recognized during active hospital log reviews deemed eligible for enrollment. Cases (IS and LRTI-related deaths) that were not captured actively will then be enrolled by setting-up interviews at hospital or home visits (IS cases only). Minimum age limit: No limit for IS cases and 29 days (inclusive) for LRTI-mortality cases A target of 660 subjects with definite IS and 200 cases of LRTI-related deaths, who received Rotarix™, is planned

Eligibility

Ages Eligible for Study:	up to 364 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria for IS cases :

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.

Inclusion criteria for Post-neonatal LRTI-related deaths:

A death is deemed eligible for the study inclusion if the following criteria are met:

Subject was an IMSS affiliate
Death is recorded at a hospital or death certificate is available
Male or female child between 29 days and 1 year of age, (i.e., includes all subjects 29 days of age up to and excluding those children on the day of their first birthday) at the time of death (fatality becomes ineligible on the day of their first birthday).
Suspected post-neonatal LRTI-related death occurred during the study period
Written informed consent is obtained from the parent/guardian/legal representative of the subject.

Exclusion Criteria:

Not applicable

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00595205

Contacts

Contact: US GSK Clinical Trials Call Center

877-379-3718

Locations

Mexico
GSK Investigational Site	Recruiting
Mexico DF, Mexico, 06720

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	104435
Study First Received:	January 4, 2008
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00595205
Health Authority:	Mexico:Instituto Mexicano del Seguro Social (IMSS)

Keywords provided by GlaxoSmithKline:

Intussusception,
vaccine safety,
epidemiology,
Mexico

Study placed in the following topic categories:

Intestinal Obstruction
Death
Digestive System Diseases

Gastrointestinal Diseases
Intussusception
Intestinal Diseases

ClinicalTrials.gov processed this record on January 16, 2009