Last updated: 11/03/2018 00:36:28
Intussusception Surveillance after Rotarix Introduction in Mexico
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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
Trial 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™.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Occurrence of definite IS episodes within Day 0 to Day 30 following vaccination
Timeframe: 0- 30 days following Rotarix vaccination
Secondary outcomes:
Occurrence of definite IS episodes within Day 0 to Day 15 following vaccination
Timeframe: Day 0 to Day 15 post Rotarix vaccination
Yearly occurrence of definite IS episodes (regardless of vaccination status)
Timeframe: Assessed for the interim analysis and after study conclusion
Interventions:
Enrollment:
786
Primary completion date:
2010-08-10
Observational study model:
Other
Time perspective:
Prospective
Clinical publications:
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.
Velázquez FR et al. (2012) Postmarketing surveillance of intussusception following mass introduction of the attenuated human rotavirus vaccine in Mexico. Pediatr Infect Dis J. 31(7):736-744.
Medical condition
Intussusception (IS), Rotavirus Vaccines
Product
SB444563
Collaborators
Not applicable
Study date(s)
January 2008 to October 2010
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable N/A - 364 days
Accepts healthy volunteers
No
- 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
- Not applicable
Inclusion and exclusion criteria
Inclusion 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.
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:
Exclusion criteria:
- Not applicable
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2010-08-10
Actual study completion date
2010-08-10
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website