Status:
COMPLETED
Randomized, Controlled Single-blind Clinical Study to Assess Vaccine Interchangeability Between RV5 and RV1 Using Seven Combined Anti-rotavirus Prevention Programs
Lead Sponsor:
National Institute of Pediatrics, Mexico
Collaborating Sponsors:
Centro Nacional para la Salud de la Infancia y la Adolescencia
Merck Sharp & Dohme LLC
Conditions:
Rotavirus Vaccine
Eligibility:
All Genders
6-10 years
Phase:
PHASE3
Brief Summary
Assess the immunological behavior of children from 2 months of age that receive one out of seven anti-rotavirus vaccination programs: Group 1 (routine schedule with two doses of RV1 - Rotarix plus ste...
Detailed Description
In this protocol we included 1498 at 6 to 8 weeks of age with a second visit at 2 months, a third visit at 4months four visit at 5 months after the first vaccination, ( 1st, second and 3erd visits for...
Eligibility Criteria
Inclusion
- The subject is a boy or a girl 2 months ± one week old at the time of the first dose of the vaccine.
- The subject is considered to be healthy based on the clinical history and the physical examination.
- The subject has not received any anti-rotavirus vaccine.
- The parent/tutor fully understands the study's procedures and voluntarily accepts to participate and signs a written informed consent.
- The parent/tutor can meet the study's requirements, such as attending the programmed visits and filling in the journal.
- Written informed consent signed by the parent/tutor before any procedure.
Exclusion
- The subject has a background of serious allergic reaction to any of the vaccine's components.
- The subject has a digestive tract malformation or acute/chronic disease.
- The subject has some kind of immunodeficiency including HIV.
- The subject suffers from a haemato-oncological disease.
- The subject has been under treatment with an immunosuppressing medicine including prednisone for two or more weeks.
- The subject has received gamma-globulin or any other blood-derived product or its administration is programmed during the study.
Key Trial Info
Start Date :
November 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2017
Estimated Enrollment :
1498 Patients enrolled
Trial Details
Trial ID
NCT02193061
Start Date
November 1 2013
End Date
November 1 2017
Last Update
August 8 2018
Active Locations (1)
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1
National Instiute of Pediatrics
México, D.F., Mexico, 04530