MeaslesPhase 4NCT03071575
Measles-Rubella Vaccine Immunogenicity at 6 and 9 Months of Age
A Phase 4 study testing Measles-rubella (MR) vaccine at 6 months of age and Measles-rubella (MR) vaccine at 9 months of age in people with Measles and Rubella, run by Centers for Disease Control and Prevention at 1 site in Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Ages 173 to 187 daysHealthy volunteers can take part
- Conditions the study is for
- Measles, Rubella, Rubella Syndrome, Congenital
- What is being tested?
- Measles-rubella (MR) vaccine at 6 months of age and Measles-rubella (MR) vaccine at 9 months of age
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 637 participants
- Where
- 1 siteBangladesh
- Study dates
- 9 Mar 2017to 18 Mar 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 173 to 187 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
- Mothers of infants that meet inclusion criteria.
- ≥18 years of age
- Mothers who consent to participate in the full length of the study
Who cannot join
- 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
Show all 17Show fewer
- 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
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing Immunogenicity of Measles-Rubella Vaccine at 6 and 9 Months of Age
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:
Read more
- To assess immunogenicity of MR vaccine at 6 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 objectives
- To assess the frequency of adverse reactions following administration of MR vaccine at 6 months
- To compare the immunogenicity of the MR vaccine first dose administered at 6 months vs at 9 months.
- To assess the proportion of mothers with undetectable, detectable and protective levels of measles and rubella antibodies
- 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
- 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
- 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
- To estimate the half-life of decay of measles and rubella antibodies in infants
Read the detailed description
In countries with low levels of circulating measles virus, and lower risk for measles infection, measles containing vaccine first dose (MCV1) is recommended at 12 months of age. In countries with high risk for measles, MCV1 is recommended at 9 months. In the past decade, many countries have been experiencing measles outbreaks with a high proportion of cases among infants < 9 months of age, below the recommended age of routine MCV1.
Recent publications suggest that this may be due to the fact that the majority of infants now are born to mothers with vaccine induced immunity to measles, and who lose maternal antibodies much earlier, by age of 4-6 months. For example, in a measles outbreak in Malawi in 2010, 14% (17,858) of the estimated 134,000 cases occurred in children 0-8 months. In 2013, in a measles outbreak in Sri Lanka approximately 34% of measles cases were in children 6-12 months of age. Furthermore, in 2013 Jordan experienced a large measles outbreak with high proportion of young infants affected (6-9 months). WHO measles outbreak response guidelines recommend vaccinating children as young as 6 months during outbreaks. As an example, in response to a measles outbreak, Sri Lanka and Jordan conducted outbreak response immunization (ORI) that included infants 6 months of age despite the limited evidence on immunogenicity of MR vaccine at that age.
Some researchers suggest that routine MCV should be given before age of 9 months based on published data showing that infants born to mothers with vaccine induced measles immunity are born with lower concentration of maternal measles antibodies (MMA) and lose protection against measles infection at an earlier age. Measles vaccine immunogenicity depends on several factors, including presence of maternal measles antibodies (i.e., passively acquired measles antibodies may neutralize vaccine virus before a complete immune response develops resulting in primary vaccine failure.), maturity of immune system of the vaccine recipient, and strain of the measles vaccine used. So any decisions to alter the age of MCV1 dose should balance the potential risk of primary vaccine failure against the risk of measles infection and measles related complications, including death. Immunogenicity of measles vaccine given at 6 months is well studied; however, data on immunogenicity of combined MR vaccine administered at 6 months and its impact on MR vaccine effectiveness given at 9 months, is limited.
Because the number of infants born to mothers with vaccine induced immunity has been steadily increasing and most countries will be using MR vaccine routinely in the Expanded Program of Immunization (EPI), it is timely to conduct a study to assess immunogenicity of MR vaccine given at 6 months and its impact on a subsequent 9 month MR dose. The first dose of MCV given at 6 months is frequently referred to as MCV-0, indicating that two subsequent doses are needed to attain population seroprotection levels necessary to stop endemic transmission of the measles virus.
To improve the accuracy of interpretation of study results blood samples of mothers of enrolled infants will be tested for measles and rubella antibodies. This will also enable us to determine the proportion of mothers with undetectable, detectable and protective levels of antibodies, and to assess the relationship between the level of antibodies in mothers and their infants' maternal antibodies.
This study will be conducted in a single site in rural Bangladesh at Matlab. Matlab is a major rural field site for icddr,b, where for the past 50 years continuous health and demographic information was collected on >200,000 population.
From 2007 to 2010, icddr,b, the Ministry of Health (MOH) in collaboration with other international organizations conducted several randomized vaccine effectiveness studies.
This study will be an open-label, randomized, 2-arm clinical trial. 620 children will be enrolled and randomized at 6 months of age to one of two study arms. The primary objectives of this study are to assess the immunogenicity of MR vaccine at 6 months, and assess equality of MR vaccine seroconversion administered at 9 months following administration of an earlier MR vaccine dose at 6 months of age compared with MR vaccine dose administered at 9 months only without previous MR vaccination. The study will enroll generally healthy 6 month old infants living in Matlab and who have never received an MR vaccine dose and have no history of measles or rubella. Participants will be followed to 11 months of age.
Infants in this study will be randomly assigned to one of two arms. Infants in Study Arm A will receive MR vaccine at 6 months of age (at enrolment) and at 9 months. Infants in Study arm B will receive MR vaccine only at 9 months.
Blood specimens will be collected from all infants at 6, 9 and 11 months of age. The 6 month sample is a pre-vaccination sample and mainly will be used to determine maternal antibody levels. For arm A, the sample collected at 9 months before the second MR dose will be used to assess antibody levels after the first MR dose at 6 months of age. For study Arm B, the 9 month sample will be used to assess measles and rubella antibody decay rate. The sample collected at 11 months will be used to assess immune response to either a two dose or a one dose schedule (arms A and B, respectively).
- Conditions
- Measles, Rubella, Rubella Syndrome, Congenital
- Being tested
- Measles-rubella (MR) vaccine at 6 months of age, Measles-rubella (MR) vaccine at 9 months of age
- Keywords
- measles, rubella, immunogenicity, congenital rubella syndrome, measles-rubella vaccine
- Medical subject headings
- Measles, Rubella, Rubella Syndrome, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measles-rubella (MR) vaccine at 6 months of ageBiological
Also called Early dose
Infants receive a standard dose according to the vaccine package insert. (Mothers receive no intervention.)
Measles-rubella (MR) vaccine at 9 months of ageBiological
Also called Standard dose
Infants receive a standard dose according to the vaccine package insert. (Mothers receive no intervention.)
| Study group | Role | What they receive |
|---|---|---|
| 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.) Receives: 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.) Receives: Biological: Measles-rubella (MR) vaccine at 9 months of age |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Infant antibody titer at 11 months.
Secondary outcomes (6)
Adverse Effects Following Immunization (AEFI) at the Age of 6 Months
To assess the frequency of adverse reactions following administration of MR vaccine at the age of 6 months. There were multiple assessment timeframes relative to the first immunization. 30 minutes direct observation at the clinic site and 48-hour follow-up visit by study staff at the home.
Measured: 0-30 minutes; 48-hour visit.
Immunogenicity at 9 Months - Measles
The average antibody levels of infants who seroconverted or responded to the measles component of the vaccine. This measures the number of antibodies against the measles virus per volume of blood. A larger number means more antibodies are present and suggests a better ability to detect and prevent infection by the measles virus.
Measured: At 9 months and 11 months of age
Immunogenicity at 9 Months - Rubella
The average antibody levels of infants who seroconverted or responded to the rubella component of the vaccine. This measures the number of antibodies against the rubella virus per volume of blood. A larger number means more antibodies are present and suggests a better ability to detect and prevent infection by the rubella virus.
Measured: At 9 months and 11 months of age
Measles and Rubella Titers of Enrolled Mothers
To assess the distribution of mothers with undetectable, detectable and protective levels of measles and rubella immunoglobulin G (IgG) antibodies
Measured: 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).
Pearson correlation coefficient, by arm at each study timepoint. It quantifies the linear relationship between two sets of variables; we compare the infant antibody levels (y axis) to that of the mother at baseline (x-axis), a proxy for infant antibody levels at birth. This is usually presented as a scatter plot. A coefficient approaching 1 or -1 indicates a strong correlation, while a coefficient near zero indicates no correlation.
Measured: baseline (6 months infant age); 2nd blood draw (9 months of age) and 3rd blood draw (at 11 months of age)
Half-life and Decay of Maternal Measles and Rubella Antibodies.
To estimate the half-life of decay of maternal measles and rubella antibodies in infants
Measured: Day 1 to day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2017
- Study start9 Mar 2017
- Primary completion18 Mar 2018
- Study completion18 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MeaslesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 637 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh, Ministry of Health and Family Welfare, Bangladesh
- Responsible party
- Principal investigator, Jennifer Knapp, Centers for Disease Control and Prevention
- Investigators
- K. Zaman, MD, Principal investigator, International Centre for Diarrhoeal Disease Research, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03071575
- Sponsor's protocol ID
- CDC
- Status last verified
- Jun 2025
- First submitted
- 21 Feb 2017
- Last updated
- 16 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40179934
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Immunogenicity of Measles-Rubella Vaccine at 6 and 9 Months of Age
- ClinicalTrials.gov ID
- NCT03071575
- Acronym / sponsor ID
- CDC
- Conditions
- Measles, Rubella, Rubella Syndrome, Congenital
- Keywords
- measles, rubella, immunogenicity, congenital rubella syndrome, measles-rubella vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 637 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh, Ministry of Health and Family Welfare, Bangladesh
- Study start
- 9 Mar 2017 (actual)
- Primary completion
- 18 Mar 2018 (actual)
- Study completion
- 18 Mar 2018 (actual)
- First posted
- 7 Mar 2017 (actual)
- Results
- Posted 16 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To assess immunogenicity of MR vaccine at 6 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 objectives
- To assess the frequency of adverse reactions following administration of MR vaccine at 6 months
- To compare the immunogenicity of the MR vaccine first dose administered at 6 months vs at 9 months.
- To assess the proportion of mothers with undetectable, detectable and protective levels of measles and rubella antibodies
- 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
- 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
- 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
- To estimate the half-life of decay of measles and rubella antibodies in infants
Detailed description
In countries with low levels of circulating measles virus, and lower risk for measles infection, measles containing vaccine first dose (MCV1) is recommended at 12 months of age. In countries with high risk for measles, MCV1 is recommended at 9 months. In the past decade, many countries have been experiencing measles outbreaks with a high proportion of cases among infants < 9 months of age, below the recommended age of routine MCV1.
Recent publications suggest that this may be due to the fact that the majority of infants now are born to mothers with vaccine induced immunity to measles, and who lose maternal antibodies much earlier, by age of 4-6 months. For example, in a measles outbreak in Malawi in 2010, 14% (17,858) of the estimated 134,000 cases occurred in children 0-8 months. In 2013, in a measles outbreak in Sri Lanka approximately 34% of measles cases were in children 6-12 months of age. Furthermore, in 2013 Jordan experienced a large measles outbreak with high proportion of young infants affected (6-9 months). WHO measles outbreak response guidelines recommend vaccinating children as young as 6 months during outbreaks. As an example, in response to a measles outbreak, Sri Lanka and Jordan conducted outbreak response immunization (ORI) that included infants 6 months of age despite the limited evidence on immunogenicity of MR vaccine at that age.
Some researchers suggest that routine MCV should be given before age of 9 months based on published data showing that infants born to mothers with vaccine induced measles immunity are born with lower concentration of maternal measles antibodies (MMA) and lose protection against measles infection at an earlier age. Measles vaccine immunogenicity depends on several factors, including presence of maternal measles antibodies (i.e., passively acquired measles antibodies may neutralize vaccine virus before a complete immune response develops resulting in primary vaccine failure.), maturity of immune system of the vaccine recipient, and strain of the measles vaccine used. So any decisions to alter the age of MCV1 dose should balance the potential risk of primary vaccine failure against the risk of measles infection and measles related complications, including death. Immunogenicity of measles vaccine given at 6 months is well studied; however, data on immunogenicity of combined MR vaccine administered at 6 months and its impact on MR vaccine effectiveness given at 9 months, is limited.
Because the number of infants born to mothers with vaccine induced immunity has been steadily increasing and most countries will be using MR vaccine routinely in the Expanded Program of Immunization (EPI), it is timely to conduct a study to assess immunogenicity of MR vaccine given at 6 months and its impact on a subsequent 9 month MR dose. The first dose of MCV given at 6 months is frequently referred to as MCV-0, indicating that two subsequent doses are needed to attain population seroprotection levels necessary to stop endemic transmission of the measles virus.
To improve the accuracy of interpretation of study results blood samples of mothers of enrolled infants will be tested for measles and rubella antibodies. This will also enable us to determine the proportion of mothers with undetectable, detectable and protective levels of antibodies, and to assess the relationship between the level of antibodies in mothers and their infants' maternal antibodies.
This study will be conducted in a single site in rural Bangladesh at Matlab. Matlab is a major rural field site for icddr,b, where for the past 50 years continuous health and demographic information was collected on >200,000 population.
From 2007 to 2010, icddr,b, the Ministry of Health (MOH) in collaboration with other international organizations conducted several randomized vaccine effectiveness studies.
This study will be an open-label, randomized, 2-arm clinical trial. 620 children will be enrolled and randomized at 6 months of age to one of two study arms. The primary objectives of this study are to assess the immunogenicity of MR vaccine at 6 months, and assess equality of MR vaccine seroconversion administered at 9 months following administration of an earlier MR vaccine dose at 6 months of age compared with MR vaccine dose administered at 9 months only without previous MR vaccination. The study will enroll generally healthy 6 month old infants living in Matlab and who have never received an MR vaccine dose and have no history of measles or rubella. Participants will be followed to 11 months of age.
Infants in this study will be randomly assigned to one of two arms. Infants in Study Arm A will receive MR vaccine at 6 months of age (at enrolment) and at 9 months. Infants in Study arm B will receive MR vaccine only at 9 months.
Blood specimens will be collected from all infants at 6, 9 and 11 months of age. The 6 month sample is a pre-vaccination sample and mainly will be used to determine maternal antibody levels. For arm A, the sample collected at 9 months before the second MR dose will be used to assess antibody levels after the first MR dose at 6 months of age. For study Arm B, the 9 month sample will be used to assess measles and rubella antibody decay rate. The sample collected at 11 months will be used to assess immune response to either a two dose or a one dose schedule (arms A and B, respectively).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: early dose | Experimental | Biological: Measles-rubella (MR) vaccine at 6 months of age, Biological: Measles-rubella (MR) vaccine at 9 months of ageInfants 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.) |
| Group B: standard dose | Active comparator | Biological: Measles-rubella (MR) vaccine at 9 months of ageInfants receive a measles-rubella vaccine at 9 months only. Infants receive a standard dose according to the vaccine package insert. (Mothers receive no intervention.) |
Who may qualify
- Ages
- 173 to 187 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
- Mothers of infants that meet inclusion criteria.
- ≥18 years of age
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measles-rubella (MR) vaccine at 6 months of ageAlso: Early doseInfants receive a standard dose according to the vaccine package insert. (Mothers receive no intervention.) | Biological | Group A: early dose |
| Measles-rubella (MR) vaccine at 9 months of ageAlso: Standard doseInfants receive a standard dose according to the vaccine package insert. (Mothers receive no intervention.) | Biological | Group A: early dose, Group B: standard dose |
Primary outcome
Percent of Infants Who Were Seropositive After Immunization at 6 Months (Assessed at 9-month Visit)
Time frame: Infant antibody titer at 9 months.
# 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
Percent of Infants Who Were Seropositive After Immunization at 9 Months (Assessed at 11-month Visit)
Time frame: Infant antibody titer at 11 months.
# 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
6 secondary outcomes
Adverse Effects Following Immunization (AEFI) at the Age of 6 Months
Time frame: 0-30 minutes; 48-hour visit.
Immunogenicity at 9 Months - Measles
Time frame: At 9 months and 11 months of age
Immunogenicity at 9 Months - Rubella
Time frame: At 9 months and 11 months of age
Measles and Rubella Titers of Enrolled Mothers
Time frame: 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).
Time frame: baseline (6 months infant age); 2nd blood draw (9 months of age) and 3rd blood draw (at 11 months of age)
Half-life and Decay of Maternal Measles and Rubella Antibodies.
Time frame: Day 1 to day 84
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40179934Sayi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
K. Zaman, MD principal investigator
International Centre for Diarrhoeal Disease Research, Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Measles-rubella (MR) vaccine at 6 months of age and Measles-rubella (MR) vaccine at 9 months of age in people with Measles and Rubella, run by Centers for Disease Control and Prevention at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Infants Who Were Seropositive After Immunization at 6 Months (Assessed at 9-month Visit) (time frame: Infant antibody titer at 9 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03071575, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.