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

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ClinicalTrials.gov Identifier: NCT02193061
Recruitment Status : Active, not recruiting
First Posted : July 17, 2014
Last Update Posted : August 18, 2017
Sponsor:
Collaborators:
Centro Nacional para la Salud de la Infancia y la Adolescencia
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Mercedes Macias Parra, National Institute of Pediatrics, Mexico

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).


Condition or disease Intervention/treatment Phase
Rotavirus Vaccine Biological: Rotarix Biological: RotaTeq Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1498 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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.
Actual Study Start Date : November 2013
Actual Primary Completion Date : June 2017
Estimated Study Completion Date : November 2017

Arm Intervention/treatment
Active Comparator: ROTA 1
two doses of monovalent vaccine Rotarix followed by one dose of sterile water
Biological: Rotarix
Active Comparator: ROTA 2
three doses of pentavalent vaccine RotaTeq
Biological: RotaTeq
Active Comparator: ROTA 3
one dose of monovalent Rotarix vaccine followed by two doses of pentavalent vaccine Rotateq
Biological: Rotarix
Biological: RotaTeq
Active Comparator: ROTA 4
one dose of pentavalent RotaTeq vaccine followed by two doses of monovalent vaccine Rotarix
Biological: Rotarix
Biological: RotaTeq
Active Comparator: ROTA 5
two doses of pentavalent vaccine RotaTeq followed by a dose of monovalent vaccine Rotarix
Biological: Rotarix
Biological: RotaTeq
Active Comparator: ROTA 6
one dose of pentavalent vaccine RotaTeq followed by a dose of monovalent vaccine Rotarix and a dose of pentavalent vaccine RotaTeq
Biological: Rotarix
Biological: RotaTeq
Active Comparator: ROTA 7
a dose of monovalent vaccine Rotarix followed by a dose of pentavalent vaccine and a dose of monovalent vaccine Rotarix
Biological: Rotarix
Biological: RotaTeq



Primary Outcome Measures :
  1. General Symptoms - Temperature [ Time Frame: subsequent 5 days since the vaccination day ]

    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.



Secondary Outcome Measures :
  1. Evacuation [ Time Frame: subsequent 30 days since the vaccination day ]
    The number of evacuations per day and their characteristics will be registered in a diary card



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Ages Eligible for Study:   6 Weeks to 10 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02193061


Locations
Mexico
National Instiute of Pediatrics
México City, D.f., Mexico, 04530
Sponsors and Collaborators
National Institute of Pediatrics, Mexico
Centro Nacional para la Salud de la Infancia y la Adolescencia
Merck Sharp & Dohme Corp.

Responsible Party: Mercedes Macias Parra, MSc, National Institute of Pediatrics, Mexico
ClinicalTrials.gov Identifier: NCT02193061     History of Changes
Other Study ID Numbers: Rota/CeNSIA
First Posted: July 17, 2014    Key Record Dates
Last Update Posted: August 18, 2017
Last Verified: August 2017

Keywords provided by Mercedes Macias Parra, National Institute of Pediatrics, Mexico:
Rotavirus
immunological behavior
Rotarix
RotaTeq
vaccine interchangeability

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs