MedTrace Logo

Measles-Rubella Vaccine Immunogenicity at 6 and 9 Months of Age

NCT03071575 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 637

Last updated 2025-07-16

Study results available
· View outcomes & findings →

Summary

This is an open-label, randomized, 2-arm clinical trial in healthy infants in Bangladesh. The primary purpose of the study is to assess the immunogenicity of measles-rubella (MR) vaccine when delivered at 6 months. In addition, the study will establish the equality of MR vaccine seroconversion administered at 9 months following administration of an earlier MR vaccine dose at 6 months of age compared to MR vaccine dose administered at 9 months without previous MR vaccination. This study will also provide additional data on safety and tolerance of MR vaccine given at 6 months, and impact of maternal antibodies on immunogenicity of MR vaccine at 6 months.

* Primary objectives:

1. To assess immunogenicity of MR vaccine at 6 months of age
2. To assess immunogenicity of MR vaccine at 9 months of age among children without prior measles and rubella vaccination, compared with MR vaccine immunogenicity among those who had a prior MR vaccination at 6 months of age
* Secondary objectives

1. To assess the frequency of adverse reactions following administration of MR vaccine at 6 months
2. To compare the immunogenicity of the MR vaccine first dose administered at 6 months vs at 9 months.
3. To assess the proportion of mothers with undetectable, detectable and protective levels of measles and rubella antibodies
4. To determine the extent of variation in measles antibodies in women of child bearing age in a population with a long standing measles vaccination program
5. To determine the extent of variation in rubella antibodies in women of child bearing age in a population where rubella vaccine have been recently introduced
6. To determine if variation in antibody levels in infants at 6 months is predominately explained by variation in starting antibody levels in the mother in this population
7. To estimate the half-life of decay of measles and rubella antibodies in infants

Conditions

  • Measles
  • Rubella
  • Rubella Syndrome, Congenital

Interventions

BIOLOGICAL

Measles-rubella (MR) vaccine at 6 months of age

Infants receive a standard dose according to the vaccine package insert. (Mothers receive no intervention.)

BIOLOGICAL

Measles-rubella (MR) vaccine at 9 months of age

Infants receive a standard dose according to the vaccine package insert. (Mothers receive no intervention.)

Sponsors & Collaborators

Principal Investigators

  • K. Zaman, MD · International Centre for Diarrhoeal Disease Research, Bangladesh

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
173 Days
Max Age
187 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-09
Primary Completion
2018-03-18
Completion
2018-03-18

Countries

  • Bangladesh

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT03071575 on ClinicalTrials.gov