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| Name | Class |
|---|---|
| Centro Nacional para la Salud de la Infancia y la Adolescencia | OTHER_GOV |
| Merck Sharp & Dohme LLC | INDUSTRY |
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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
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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ROTA 1 | Active Comparator | two doses of monovalent vaccine Rotarix followed by one dose of sterile water |
|
| ROTA 2 | Active Comparator | three doses of pentavalent vaccine RotaTeq |
|
| ROTA 3 | Active Comparator | one dose of monovalent Rotarix vaccine followed by two doses of pentavalent vaccine Rotateq |
|
| ROTA 4 | Active Comparator | one dose of pentavalent RotaTeq vaccine followed by two doses of monovalent vaccine Rotarix |
|
| ROTA 5 | Active Comparator | two doses of pentavalent vaccine RotaTeq followed by a dose of monovalent vaccine Rotarix |
|
| ROTA 6 | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotarix | Biological |
| ||
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Instiute of Pediatrics | México | D.F. | 04530 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38463163 | Derived | Macias-Parra M, Vidal-Vazquez P, Reyna-Figueroa J, Rodriguez-Weber MA, Moreno-Macias H, Hernandez-Benavides I, Fortes-Gutierrez S, Richardson VL, Vazquez-Cardenas P. Immunogenicity of RV1 and RV5 vaccines administered in standard and interchangeable mixed schedules: a randomized, double-blind, non-inferiority clinical trial in Mexican infants. Front Public Health. 2024 Feb 23;12:1356932. doi: 10.3389/fpubh.2024.1356932. eCollection 2024. |
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one dose of pentavalent vaccine RotaTeq followed by a dose of monovalent vaccine Rotarix and a dose of pentavalent vaccine RotaTeq
|
| ROTA 7 | Active Comparator | a dose of monovalent vaccine Rotarix followed by a dose of pentavalent vaccine and a dose of monovalent vaccine Rotarix |
|
| RotaTeq |
| Biological |
|
| ID | Term |
|---|---|
| C492457 | RIX4414 vaccine |
| C492535 | RotaTeq |
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