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

NCT ID: NCT02193061

Last Updated: 2018-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1498 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2017-11-30

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.

Conditions

Rotavirus Vaccine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

ROTA 1

two doses of monovalent vaccine Rotarix followed by one dose of sterile water

Group Type: ACTIVE_COMPARATOR

Rotarix

Intervention Type: BIOLOGICAL

ROTA 2

three doses of pentavalent vaccine RotaTeq

Group Type: ACTIVE_COMPARATOR

RotaTeq

Intervention Type: BIOLOGICAL

ROTA 3

one dose of monovalent Rotarix vaccine followed by two doses of pentavalent vaccine Rotateq

Group Type: ACTIVE_COMPARATOR

Rotarix

Intervention Type: BIOLOGICAL

RotaTeq

Intervention Type: BIOLOGICAL

ROTA 4

one dose of pentavalent RotaTeq vaccine followed by two doses of monovalent vaccine Rotarix

Group Type: ACTIVE_COMPARATOR

Rotarix

Intervention Type: BIOLOGICAL

RotaTeq

Intervention Type: BIOLOGICAL

ROTA 5

two doses of pentavalent vaccine RotaTeq followed by a dose of monovalent vaccine Rotarix

Group Type: ACTIVE_COMPARATOR

Rotarix

Intervention Type: BIOLOGICAL

RotaTeq

Intervention Type: BIOLOGICAL

ROTA 6

one dose of pentavalent vaccine RotaTeq followed by a dose of monovalent vaccine Rotarix and a dose of pentavalent vaccine RotaTeq

Group Type: ACTIVE_COMPARATOR

Rotarix

Intervention Type: BIOLOGICAL

RotaTeq

Intervention Type: BIOLOGICAL

ROTA 7

a dose of monovalent vaccine Rotarix followed by a dose of pentavalent vaccine and a dose of monovalent vaccine Rotarix

Group Type: ACTIVE_COMPARATOR

Rotarix

Intervention Type: BIOLOGICAL

RotaTeq

Intervention Type: BIOLOGICAL

Interventions

Rotarix

Intervention Type: BIOLOGICAL

RotaTeq

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 6 Weeks
• Maximum Eligible Age: 10 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centro Nacional para la Salud de la Infancia y la Adolescencia

OTHER_GOV

Sponsor Role: collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

National Institute of Pediatrics, Mexico

OTHER_GOV

Sponsor Role: lead

Responsible Party

Mercedes Macias Parra

MSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

National Instiute of Pediatrics

México, D.F., Mexico

Countries

Mexico

References

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.

Reference Type: DERIVED

PMID: 38463163 (View on PubMed)

Other Identifiers

Rota/CeNSIA

Identifier Type: -

Identifier Source: org_study_id