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

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.

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.