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

Rotavirus Vaccine Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02193061
• Other study ID #: Rota/CeNSIA
• Status: Completed
• Phase: Phase 3
• Start date: November 2013
• Est. completion date: November 2017

Study information

• Verified date: August 2018
• Source: National Institute of Pediatrics, Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1498
• Est. completion date: November 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Weeks to 10 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Rotavirus Vaccine

Intervention

Biological:
• Rotarix

• RotaTeq

Locations

Country	Name	City	State
Mexico	National Instiute of Pediatrics	México City	D.f.

Sponsors (3)

Lead Sponsor	Collaborator
National Institute of Pediatrics, Mexico	Centro Nacional para la Salud de la Infancia y la Adolescencia, Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evacuation	The number of evacuations per day and their characteristics will be registered in a diary card	subsequent 30 days since the vaccination day