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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Rotavirus Vaccine

Intervention / Treatment
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* Biological: Rotarix
* Biological: RotaTeq


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Weeks
Maximum Age: 10 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ROTA 1<br>two doses of monovalent vaccine Rotarix followed by one dose of sterile water | Biological: Rotarix<br> <br> |
| Active Comparator: ROTA 2<br>three doses of pentavalent vaccine RotaTeq | Biological: RotaTeq<br> <br> |
| Active Comparator: ROTA 3<br>one dose of monovalent Rotarix vaccine followed by two doses of pentavalent vaccine Rotateq | Biological: Rotarix<br> <br> Biological: RotaTeq<br> <br> |
| Active Comparator: ROTA 4<br>one dose of pentavalent RotaTeq vaccine followed by two doses of monovalent vaccine Rotarix | Biological: Rotarix<br> <br> Biological: RotaTeq<br> <br> |
| Active Comparator: ROTA 5<br>two doses of pentavalent vaccine RotaTeq followed by a dose of monovalent vaccine Rotarix | Biological: Rotarix<br> <br> Biological: RotaTeq<br> <br> |
| Active Comparator: ROTA 6<br>one dose of pentavalent vaccine RotaTeq followed by a dose of monovalent vaccine Rotarix and a dose of pentavalent vaccine RotaTeq | Biological: Rotarix<br> <br> Biological: RotaTeq<br> <br> |
| Active Comparator: ROTA 7<br>a dose of monovalent vaccine Rotarix followed by a dose of pentavalent vaccine and a dose of monovalent vaccine Rotarix | Biological: Rotarix<br> <br> Biological: RotaTeq<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General Symptoms - Temperature | The subject temperature will be registered with a rectal thermometer during 5 days since the vaccination day in a diary card . If the subject presents fever, the temperature will be recorded in a specific diary card section. | subsequent 5 days since the vaccination day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evacuation | The number of evacuations per day and their characteristics will be registered in a diary card | subsequent 30 days since the vaccination day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rotavirus, immunological behavior, Rotarix, RotaTeq, vaccine interchangeability