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

NCT03071575 | Completed Phase 4 Results DMC

• 1 other identifier: CDC
• Study Type: interventional
• Target: 637
• Locations: 1 country
• Sites: 1

Brief 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.

1. 1.To assess immunogenicity of MR vaccine at 6 months of age
2. 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
3. 3.Secondary objectives
4. 4.To assess the frequency of adverse reactions following administration of MR vaccine at 6 months
5. 5.To compare the immunogenicity of the MR vaccine first dose administered at 6 months vs at 9 months.
6. 6.To assess the proportion of mothers with undetectable, detectable and protective levels of measles and rubella antibodies
7. 7.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
8. 8.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
9. 9.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
10. 10.To estimate the half-life of decay of measles and rubella antibodies in infants

Conditions

Measles; Rubella; Rubella Syndrome, Congenital

Keywords

measles; rubella; immunogenicity; congenital rubella syndrome; measles-rubella vaccine

Outcome Measures

Primary Outcomes (2)

• Percent of Infants Who Were Seropositive After Immunization at 6 Months (Assessed at 9-month Visit)

  \# seropositive infants at 9 months/ # of infants in the arm Measles neutralizing antibody titers as measured by plaque reduction neutralization assay is defined as seropositive at ≥ 120 mIU/mL. Rubella antibody titers as measured by ELISA are considered seropositive at \>10 IU/mL. Abbreviations mIU =milli-International unit; IU International units; mL milliliter

  Infant antibody titer at 9 months.

• Percent of Infants Who Were Seropositive After Immunization at 9 Months (Assessed at 11-month Visit)

  \# seropositive at 11 months of age/ # of infants in the arm \* 100 Measles neutralizing antibody titers as measured by plaque reduction neutralization assay is defined as seropositive at ≥ 120 mIU/mL. Rubella antibody titers as measured by ELISA are considered seropositive at \>10 IU/mL. Abbreviations mIU =milli-International unit; IU International units; mL milliliter

  Infant antibody titer at 11 months.

Secondary Outcomes (6)

• Adverse Effects Following Immunization (AEFI) at the Age of 6 Months

  0-30 minutes; 48-hour visit.

• Immunogenicity at 9 Months - Measles

  At 9 months and 11 months of age

• Immunogenicity at 9 Months - Rubella

  At 9 months and 11 months of age

• Measles and Rubella Titers of Enrolled Mothers

  Baseline enrollment (when infant was 6 months of age)

• 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).

  baseline (6 months infant age); 2nd blood draw (9 months of age) and 3rd blood draw (at 11 months of age)

Study Arms (2)

Group A: early dose

EXPERIMENTAL

Infants receive a measles-rubella vaccine at 6 and 9 months. Infants receive a standard dose according to the vaccine package insert each time. (Mothers receive no intervention.)

Biological: Measles-rubella (MR) vaccine at 6 months of age; Biological: Measles-rubella (MR) vaccine at 9 months of age

Group B: standard dose

ACTIVE COMPARATOR

Infants receive a measles-rubella vaccine at 9 months only. 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

Interventions

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

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

Also known as: Early dose

Group A: early dose

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

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

Also known as: Standard dose

Group A: early dose; Group B: standard dose

Eligibility Criteria

• Age: 173 Days - 187 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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
• ≥18 years of age
• Mothers who consent to participate in the full length of the study

You may not qualify if:

• 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)
• 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
• Acute febrile illness (≥38°C) at the time of enrollment

Sponsors & Collaborators

• Centers for Disease Control and Prevention: lead
• International Centre for Diarrhoeal Disease Research, Bangladesh: collaborator
• Ministry of Health and Family Welfare, Bangladesh: collaborator

Study Sites (1)

Icddr,B

Chāndpur, Bangladesh

Location

Related Publications (1)

• Sayi TS, Sharapov UM, Matson Z, Coughlin MM, Crooke SN, An Q, Knapp JK, Aziz AB, Yunus M, Haque W, Rana S, Khan MAF, Alexander JP, Kretsinger K, Rota PA, Zaman K, Anand A. Immunogenicity and safety of a measles and rubella-containing vaccine at age 6 and 9 months in Bangladesh: an open-label, randomised trial. Lancet Child Adolesc Health. 2025 May;9(5):306-314. doi: 10.1016/S2352-4642(25)00090-2. Epub 2025 Mar 31.

  PMID: 40179934 DERIVED

MeSH Terms

Conditions

Measles; Rubella; Rubella Syndrome, Congenital

Interventions

Aging

Condition Hierarchy (Ancestors)

Morbillivirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections; Rubivirus Infections; Togaviridae Infections; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Growth and Development; Physiological Phenomena

Results Point of Contact

• Title: Dr. Takudzwa SAYI
• Organization: Centers for Disease Control and Prevention

prp2@cdc.gov

404-718-3797

Study Officials

• K. Zaman, MD

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open label
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Epidemiologist

Study Record Dates

• First Submitted: February 21, 2017
• First Posted: March 7, 2017
• Study Start: March 9, 2017
• Primary Completion: March 18, 2018
• Study Completion: March 18, 2018
• Last Updated: July 16, 2025
• Results First Posted: July 16, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)