A Phase 3 interventional study of Rotarix and RotaTeq in Rotavirus Vaccine, sponsored by National Institute of Pediatrics, Mexico. Completed at 1 site in Mexico. Open to participants aged 6 Weeks to 10 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-08.
Sponsored by National Institute of Pediatrics, Mexico · Phase 3, Interventional, and Prevention
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 sterile water) and Group 2 (routine schedule with three doses of RV5 - RotaTeq) versus Group 3 (one dose of monovalent vaccine followed by two doses of pentavalent vaccine), Group 4 (one dose of pentavalent vaccine followed by two doses of monovalent vaccine), Group 5 (two doses of pentavalent vaccine followed by a dose of monovalent vaccine), Group 6 (one dose of pentavalent vaccine followed by a dose of monovalent vaccine and a dose of pentavalent vaccine), and Group 7 (a dose of monovalent vaccine followed by a dose of pentavalent vaccine and a dose of monovalent vaccine) in children from Mexico City.
Secondary objectives
Hypotheses The seroconversion percentages and geometric mean titers (GMT) of anti-rotavirus antibodies from Groups 3, 4, 5, 6 and 7 are not inferior to the seroconversion percentages and the GMTs induced in subjects that received the routine vaccination schedules with two doses of the monovalent vaccine and three doses of the pentavalent vaccine (Groups 1 and 2).
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 vaccine administration) phone calls every month and not schedule visits at the center when parents required and the last protocol visit was at one year of age This follow up to one year was to access security.
National Institute of Pediatrics, Mexico is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
two doses of monovalent vaccine Rotarix followed by one dose of sterile water
Biological: Rotarix
three doses of pentavalent vaccine RotaTeq
Biological: RotaTeq
one dose of monovalent Rotarix vaccine followed by two doses of pentavalent vaccine Rotateq
Biological: Rotarix · Biological: RotaTeq
one dose of pentavalent RotaTeq vaccine followed by two doses of monovalent vaccine Rotarix
Biological: Rotarix · Biological: RotaTeq
two doses of pentavalent vaccine RotaTeq followed by a dose of monovalent vaccine Rotarix
Biological: Rotarix · Biological: RotaTeq
one dose of pentavalent vaccine RotaTeq followed by a dose of monovalent vaccine Rotarix and a dose of pentavalent vaccine RotaTeq
Biological: Rotarix · Biological: RotaTeq
a dose of monovalent vaccine Rotarix followed by a dose of pentavalent vaccine and a dose of monovalent vaccine Rotarix
Biological: Rotarix · Biological: RotaTeq
General Symptoms - Temperature
The subject temperature will be registered with a rectal thermometer during 5 days since the vaccination day in a diary card . If the subject presents fever, the temperature will be recorded in a specific diary card section.
Time frame: subsequent 5 days since the vaccination day
Evacuation
The number of evacuations per day and their characteristics will be registered in a diary card
Time frame: subsequent 30 days since the vaccination day
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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National Institute of Pediatrics, Mexico