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

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ClinicalTrials.gov Identifier: NCT03071575
Recruitment Status : Not yet recruiting
First Posted : March 7, 2017
Last Update Posted : March 7, 2017
Sponsor:
Collaborators:
The International Centre for Diarrhoeal Disease Research, Bangladesh
Ministry of Health and Family Welfare, Bangladesh
Information provided by (Responsible Party):
Umid Sharapov, Centers for Disease Control and Prevention

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.

  • 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

Condition or disease Intervention/treatment Phase
Measles Rubella Rubella Syndrome, Congenital Biological: Measles-rubella (MR) vaccine at 6 and 9 months Biological: Measles-rubella (MR) vaccine at 9 months Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 620 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Open label
Primary Purpose: Prevention
Official Title: Assessing Immunogenicity of Measles-Rubella Vaccine at 6 and 9 Months of Age
Estimated Study Start Date : March 9, 2017
Estimated Primary Completion Date : October 27, 2017
Estimated Study Completion Date : October 27, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Measles Rubella

Arm Intervention/treatment
Active Comparator: Group A:
Group A will receive a measles-rubella vaccine dose at 6 and 9 months
Biological: Measles-rubella (MR) vaccine at 6 and 9 months
Arm A will receive MR vaccine dose at 6 and 9 months of age
Other Name: Arm A

Active Comparator: Group B:
Group B will receive a measles-rubella dose at 9 months only
Biological: Measles-rubella (MR) vaccine at 9 months
Arm A will receive MR vaccine dose at 9 months of age
Other Name: Arm B




Primary Outcome Measures :
  1. Seroconversion at 6 months [ Time Frame: Change in antibody titers at 9 months compared to 6 months of age ]
    Measles neutralizing antibody titers (measured by plaque reduction neutralization test) and rubella titers (IU/mL) (measured by ELISA) on sera collected at 9 months of age. Seroprotection is defined as antibody level of ≥ 120 mIU/mL for measles and >10IU/mL for rubella.

  2. Seroconversion at 9 months [ Time Frame: At 11 months of age. ]
    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 Outcome Measures :
  1. Adverse Effects Following Immunization (AEFI) [ Time Frame: Day 1 to Day 84 ]
    To assess the frequency of adverse reactions following administration of MR vaccine at 6 months

  2. Immunogenicity at 9 months [ Time Frame: At 9 months and 11 months of age ]
    To compare the immunogenicity of the MR vaccine first dose administered at 6 months vs at 9 months

  3. Measles and rubella titers of enrolled mothers [ Time Frame: At day 1 ]
    To assess the proportion of mothers with undetectable, detectable and protective levels of measles and rubella antibodies

  4. Correlation of mothers' measles and rubella antibody levels with infants' maternal antibodies [ Time Frame: Time from randomization to 9 and 11 months ]
    To assess the correlation between measles and rubella antibody levels in women and levels of maternal antibodies in infants

  5. Half-life and decay of maternal measles and rubella antibodies. [ Time Frame: Day 1 to day 84 ]
    To estimate the half-life of decay of maternal measles and rubella antibodies in infants



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Ages Eligible for Study:   6 Months to 11 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 enrolment (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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03071575


Contacts
Contact: Umid Sharapov, MD, MSc +1-404-639-2078 usharapov@cdc.gov
Contact: Abhijeet Anand, MD, MPH +1-404-639-1970 aanand@cdc.gov

Sponsors and Collaborators
Centers for Disease Control and Prevention
The International Centre for Diarrhoeal Disease Research, Bangladesh
Ministry of Health and Family Welfare, Bangladesh
Investigators
Principal Investigator: K. Zaman, MD International Centre for Diarrhoeal Disease Research, Bangladesh

Responsible Party: Umid Sharapov, medical epidemiologist, Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT03071575     History of Changes
Other Study ID Numbers: CDC
First Posted: March 7, 2017    Key Record Dates
Last Update Posted: March 7, 2017
Last Verified: March 2017

Keywords provided by Umid Sharapov, Centers for Disease Control and Prevention:
measles
rubella
immunogenicity
congenital rubella syndrome
measles-rubella vaccine

Additional relevant MeSH terms:
Measles
Rubella
Rubella Syndrome, Congenital
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Rubivirus Infections
Togaviridae Infections
Abnormalities, Multiple
Congenital Abnormalities
Vaccines
Immunologic Factors
Physiological Effects of Drugs