Phase 4 N=620 Randomized Prevention

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

Measles · Rubella · Rubella Syndrome, Congenital

Bottom Line

View on ClinicalTrials.gov: NCT03071575 ↗

Enrolled (actual)

620

Serious AEs

2.7%

Results posted

Jul 2025

Primary outcome: Primary: Percent of Infants Who Were Seropositive After Immunization at 6 Months (Assessed at 9-month Visit) — 94; 94 percentage of infants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Measles-rubella (MR) vaccine at 6 months of age (Biological); Measles-rubella (MR) vaccine at 9 months of age (Biological)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Centers for Disease Control and Prevention
Primary completion: Mar 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent of Infants Who Were Seropositive After Immunization at 6 Months (Assessed at 9-month Visit)	94; 94	—
PRIMARY Percent of Infants Who Were Seropositive After Immunization at 9 Months (Assessed at 11-month Visit)	99; 100; 99; 100	—
SECONDARY Adverse Effects Following Immunization (AEFI) at the Age of 6 Months	3; 0; 7; 5; 1; 285	—
SECONDARY Immunogenicity at 9 Months - Measles	914; 1453; 1311	—
SECONDARY Immunogenicity at 9 Months - Rubella	102; 94; 155	—
SECONDARY Measles and Rubella Titers of Enrolled Mothers	0; 0; 46; 37; 255; 255	—
SECONDARY Pearson Correlation Coefficient of Infant Measles and Rubella Antibody Levels at 6, 9, and 11 Months of Age Compared to Maternal Antibody Levels at Baseline (a Proxy for Infant Antibody Levels at Birth).	0.72; 0.66; -0.26; 0.32; -0.03; 0.02	—
SECONDARY Half-life and Decay of Maternal Measles and Rubella Antibodies.	—	—

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

Eligibility Criteria

Age is based on the age of the infant.

Inclusion Criteria: INFANTS:

Healthy infants at 6 months (180 days, +/- 7 days) of age
A parent or guardian that consents for participation in the full length of the study
A parent or guardian that is able to understand and comply with planned study procedures

Inclusion criteria: MOTHERS:

Mothers of infants that meet inclusion criteria.
≥18 years of age
Mothers who consent to participate in the full length of the study

Exclusion Criteria: INFANTS:

Family that is unable to participate in the full length of the study
A diagnosis or suspicion of immunodeficiency disorder either in the infant or mother
A diagnosis or suspicion of bleeding disorder that would contraindicate parenteral administration of MR vaccine or collection of blood by venipuncture
Acute infection or illness at the time of enrollment (6 months) that would require infant's admission to a hospital
Receipt of any measles or rubella containing vaccine prior to enrolment (i.e., before age 6 months) outside of study based upon documentation or parental recall
Known history of laboratory confirmed measles or rubella infection
A diagnosis of rubella infection in mother during pregnancy
A diagnosis of congenital rubella syndrome in infant
Known allergy/sensitivity or reaction to measles-rubella containing vaccine or contents of measles-rubella containing vaccine
Persons with a history of an anaphylactic reaction to any components of the vaccine
Infants from premature births (<37 weeks of gestation)

Exclusion criteria: MOTHERS:

Refuses to give blood samples. (If the mother agrees for her child to participate in the study, but refuses to give a blood samples herself or blood samples cannot be obtained, the child will still be enrolled.)
A diagnosis or suspicion of immunodeficiency disorder
A diagnosis or suspicion of bleeding disorder that would contraindicate collection of blood by venipuncture

Temporary exclusion: INFANTS:

Acute febrile illness (≥38°C) at the time of enrollment
Family will be requested to bring back the child 1-2 days later or when child feels better.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03071575). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.