Clinical trial NCT02193061: Randomized, Controlled Single-blind Clinical Study to Assess Vaccine Interchangeability Between RV5 and RV1 Using Seven Combined Anti-rotavirus Prevention Programs
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rotavirus Vaccine
Keywords: Rotavirus
immunological behavior
Rotarix
RotaTeq
vaccine interchangeability
Lead sponsor: National Institute of Pediatrics, Mexico
Sponsor class: OTHER_GOV
Collaborators: name: Centro Nacional para la Salud de la Infancia y la Adolescencia
name: Merck Sharp & Dohme LLC
First posted: 2014-07-17
Enrollment: 1498
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: General Symptoms - Temperature
timeFrame: subsequent 5 days since the vaccination day
Secondary outcomes:
measure: Evacuation
timeFrame: subsequent 30 days since the vaccination day
Other outcomes:
Locations:
city: México City
country: Mexico
facility: National Instiute of Pediatrics
state: D.f.
Study officials:
References: