NCT02193061

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,498

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Nov 2013

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 17, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

August 8, 2018

Status Verified

August 1, 2018

Enrollment Period

3.6 years

First QC Date

July 7, 2014

Last Update Submit

August 6, 2018

Conditions

Rotavirus Vaccine

Keywords

Rotavirusimmunological behaviorRotarixRotaTeqvaccine interchangeability

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Evacuation

    subsequent 30 days since the vaccination day

Study Arms (7)

ROTA 1

ACTIVE COMPARATOR

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

Biological: Rotarix

ROTA 2

ACTIVE COMPARATOR

three doses of pentavalent vaccine RotaTeq

Biological: RotaTeq

ROTA 3

ACTIVE COMPARATOR

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

Biological: RotarixBiological: RotaTeq

ROTA 4

ACTIVE COMPARATOR

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

Biological: RotarixBiological: RotaTeq

ROTA 5

ACTIVE COMPARATOR

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

Biological: RotarixBiological: RotaTeq

ROTA 6

ACTIVE COMPARATOR

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

Biological: RotarixBiological: 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

Biological: RotarixBiological: RotaTeq

Interventions

RotarixBIOLOGICAL
ROTA 1ROTA 3ROTA 4ROTA 5ROTA 6ROTA 7
RotaTeqBIOLOGICAL
ROTA 2ROTA 3ROTA 4ROTA 5ROTA 6ROTA 7

Eligibility Criteria

Age6 Weeks - 10 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Instiute of Pediatrics

México, D.F., 04530, Mexico

Location

Related Publications (1)

  • 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.

    PMID: 38463163DERIVED

MeSH Terms

Interventions

RIX4414 vaccineRotaTeq

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc

Study Record Dates

First Submitted

July 7, 2014

First Posted

July 17, 2014

Study Start

November 1, 2013

Primary Completion

June 1, 2017

Study Completion

November 1, 2017

Last Updated

August 8, 2018

Record last verified: 2018-08

Locations

ME(1)