Overview

This trial is active, not recruiting.

Condition rotavirus vaccine
Treatments rotarix, rotateq
Phase phase 3
Sponsor National Institute of Pediatrics, Mexico
Collaborator Centro Nacional para la Salud de la Infancia y la Adolescencia
Start date November 2013
End date October 2016
Trial size 1498 participants
Trial identifier NCT02193061, Rota/CeNSIA

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model crossover assignment
Masking single blind (subject)
Primary purpose prevention
Arm
(Active Comparator)
two doses of monovalent vaccine Rotarix followed by one dose of sterile water
rotarix
(Active Comparator)
three doses of pentavalent vaccine RotaTeq
rotateq
(Active Comparator)
one dose of monovalent Rotarix vaccine followed by two doses of pentavalent vaccine Rotateq
rotarix
rotateq
(Active Comparator)
one dose of pentavalent RotaTeq vaccine followed by two doses of monovalent vaccine Rotarix
rotarix
rotateq
(Active Comparator)
two doses of pentavalent vaccine RotaTeq followed by a dose of monovalent vaccine Rotarix
rotarix
rotateq
(Active Comparator)
one dose of pentavalent vaccine RotaTeq followed by a dose of monovalent vaccine Rotarix and a dose of pentavalent vaccine RotaTeq
rotarix
rotateq
(Active Comparator)
a dose of monovalent vaccine Rotarix followed by a dose of pentavalent vaccine and a dose of monovalent vaccine Rotarix
rotarix
rotateq

Primary Outcomes

Measure
General Symptoms - Temperature
time frame: subsequent 5 days since the vaccination day

Secondary Outcomes

Measure
Evacuation
time frame: subsequent 30 days since the vaccination day

Eligibility Criteria

Male or female participants from 6 weeks up to 10 weeks old.

Inclusion Criteria: - 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 Criteria: - 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.

Additional Information

Official title 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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by National Institute of Pediatrics, Mexico.