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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02193061
• Date of registration: 07/07/2014
• Prospective Registration: No
• Primary sponsor: National Institute of Pediatrics, Mexico
• Public title: Randomized, Controlled Single-blind Clinical Study to Assess Vaccine Interchangeability Between RV5 and RV1 Using Seven Combined Anti-rotavirus Prevention Programs
• Scientific 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.
• Date of first enrolment: November 2013
• Target sample size: 1498
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02193061
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Prevention. Masking: Single (Participant).
• Phase: Phase 3

Countries of recruitment

Mexico

Key inclusion & exclusion 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.



Age minimum: 6 Weeks
Age maximum: 10 Weeks
Gender: All

Health Condition(s) or Problem(s) studied

Rotavirus Vaccine

Intervention(s)

Biological: RotaTeq

Biological: Rotarix

Primary Outcome(s)

General Symptoms - Temperature [Time Frame: subsequent 5 days since the vaccination day]

Secondary Outcome(s)

Evacuation [Time Frame: subsequent 30 days since the vaccination day]

Secondary ID(s)

Rota/CeNSIA

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Merck Sharp & Dohme Corp.

Centro Nacional para la Salud de la Infancia y la Adolescencia