NCT02193061

Randomized, Controlled Single-blind Clinical Study to Assess Vaccine Interchangeability Between RV5 and RV1 Using Seven Combined Anti-rotavirus Prevention Programs

Randomized, Controlled Single-blind Clinical Study to Assess Vaccine Interchangeability Between Rota Vaccine 5 and Rota Vaccine 1 Using Seven Combined Anti-rotavirus Prevention Programs: ROTA 1,ROTA 2,ROTA 3,ROTA 4,ROTA 5,ROTA 6,ROTA 7 in Infants at 2, 4 and 6 Months of Age in Mexico City.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,498 (actual)
• Sponsor: National Institute of Pediatrics, Mexico · Other Government
• Sex: All
• Age: 6 Weeks – 10 Weeks
• Healthy volunteers: Accepted

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 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 * To describe number and features of acute diarrheal disease (ADD) due to rotavirus displayed in the seven prevention schedules. * To describe the adverse events temporarily associated with the seven prevention schedules. 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).

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 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.

Conditions

• Rotavirus Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	Rotarix
BIOLOGICAL	RotaTeq

Timeline

• Start date: 2013-11-01
• Primary completion: 2017-06-01
• Completion: 2017-11-01
• First posted: 2014-07-17
• Last updated: 2018-08-08

Locations

1 site across 1 country: Mexico