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Coadministration of Measles-rubella and Rotavirus Vaccines

NCT01700621 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 482

Last updated 2019-03-13

Study results available
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Summary

The investigators aim to establish the non-inferiority of concomitant administration of measles-rubella and rotavirus vaccines to measles-rubella vaccine given alone in terms of measles seroconversion rates. The primary study hypothesis is the measles seroconversion rate as defined by the percentage of children seroconverting to measles with a measles serum antibody concentration of \>=1:120 at 8 weeks post vaccination after the concomitant administration of measles-rubella and rotavirus vaccines is non-inferior to that obtained when measles-rubella vaccine is given alone in children 9 months of age who have received a primary rotavirus vaccine series with the first dose between 6 and 10 weeks and the second at least 4 weeks later and are seronegative for measles antibody in the pre-vaccination sample.

Conditions

  • Measles Antibody Seroconversion
  • Rubella Antibody Seroconversion
  • Rotavirus Geometric Mean Titer (GMT)
  • Rotavirus Immunoglobulin A (IgA) Seropositivity

Interventions

BIOLOGICAL

Rotarix vaccine

one 1.0 ml dose of oral rotavirus vaccine at 9 months of age

BIOLOGICAL

measles-rubella vaccine

one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine

Sponsors & Collaborators

  • PATH

    lead OTHER

Principal Investigators

  • K Zaman, PhD, MPH · International Centre for Diarrhoeal Disease Research, Bangladesh

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
9 Months
Max Age
11 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • Bangladesh

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01700621 on ClinicalTrials.gov