Trial Outcomes & Findings for Measles-Rubella Vaccine Immunogenicity at 6 and 9 Months of Age (NCT NCT03071575)
NCT ID: NCT03071575
Last Updated: 2025-07-16
Results Overview
\# 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
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
637 participants
Primary outcome timeframe
Infant antibody titer at 9 months.
Results posted on
2025-07-16
Participant Flow
Of 637 mother/infant dyads assessed for eligibility, 620 met inclusion criteria and were randomized to either Group A or Group B.
Participant milestones
| Measure |
Group A: Early Dose
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.)
|
Group B: Standard Dose
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.)
|
|---|---|---|
|
Overall Study
STARTED
|
312
|
308
|
|
Overall Study
COMPLETED
|
303
|
294
|
|
Overall Study
NOT COMPLETED
|
9
|
14
|
Reasons for withdrawal
| Measure |
Group A: Early Dose
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.)
|
Group B: Standard Dose
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.)
|
|---|---|---|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
5
|
11
|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group A: Early Dose
n=301 Participants
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.)
|
Group B: Standard Dose
n=292 Participants
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.)
|
Total
n=593 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26.5 years
STANDARD_DEVIATION 5.4 • n=301 Participants
|
26.4 years
STANDARD_DEVIATION 5.6 • n=292 Participants
|
26.5 years
STANDARD_DEVIATION 5.5 • n=593 Participants
|
|
Sex: Female, Male
Female
|
156 Participants
n=301 Participants
|
146 Participants
n=292 Participants
|
302 Participants
n=593 Participants
|
|
Sex: Female, Male
Male
|
145 Participants
n=301 Participants
|
146 Participants
n=292 Participants
|
291 Participants
n=593 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Stunting present
|
29 Participants
n=301 Participants
|
35 Participants
n=292 Participants
|
64 Participants
n=593 Participants
|
|
Wasting present
|
15 Participants
n=301 Participants
|
12 Participants
n=292 Participants
|
27 Participants
n=593 Participants
|
|
Measles seropositivity (Infants)
|
10 Participants
n=301 Participants
|
6 Participants
n=292 Participants
|
16 Participants
n=593 Participants
|
|
Rubella seropositivity (Infants)
|
8 Participants
n=301 Participants
|
9 Participants
n=292 Participants
|
17 Participants
n=593 Participants
|
PRIMARY outcome
Timeframe: Infant antibody titer at 9 months.Population: This is an analysis of Group A infants only, as Group B infants did not receive a vaccine at 6 months. (No mothers were vaccinated in this study)
\# 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
Outcome measures
| Measure |
Group A:
n=301 Participants
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.)
|
Group B: Standard Dose
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.)
|
|---|---|---|
|
Percent of Infants Who Were Seropositive After Immunization at 6 Months (Assessed at 9-month Visit)
Measles
|
94 percentage of infants
Interval 90.0 to 96.0
|
—
|
|
Percent of Infants Who Were Seropositive After Immunization at 6 Months (Assessed at 9-month Visit)
Rubella
|
94 percentage of infants
Interval 91.0 to 96.0
|
—
|
PRIMARY outcome
Timeframe: Infant antibody titer at 11 months.Population: Infants only, no mothers were vaccinated as part of this study.
\# 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
Outcome measures
| Measure |
Group A:
n=301 Participants
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.)
|
Group B: Standard Dose
n=292 Participants
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.)
|
|---|---|---|
|
Percent of Infants Who Were Seropositive After Immunization at 9 Months (Assessed at 11-month Visit)
Measles
|
99 percentage of infants
Interval 97.0 to 100.0
|
100 percentage of infants
Interval 98.0 to 100.0
|
|
Percent of Infants Who Were Seropositive After Immunization at 9 Months (Assessed at 11-month Visit)
Rubella
|
99 percentage of infants
Interval 96.0 to 100.0
|
100 percentage of infants
Interval 98.0 to 100.0
|
SECONDARY outcome
Timeframe: 0-30 minutes; 48-hour visit.Population: This is an analysis of Group A infants only, as Group B infants did not receive a vaccine at 6 months. (No mothers were vaccinated in this study)
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.
Outcome measures
| Measure |
Group A:
n=301 Participants
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.)
|
Group B: Standard Dose
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.)
|
|---|---|---|
|
Adverse Effects Following Immunization (AEFI) at the Age of 6 Months
Redness at the injection site (in 30 minutes)
|
3 Participants
|
—
|
|
Adverse Effects Following Immunization (AEFI) at the Age of 6 Months
Redness at the injection site (0.5 to 48 hours)
|
0 Participants
|
—
|
|
Adverse Effects Following Immunization (AEFI) at the Age of 6 Months
Fever (in 48 hours)
|
7 Participants
|
—
|
|
Adverse Effects Following Immunization (AEFI) at the Age of 6 Months
Cough, coryza, sneezing, or cold (in 48 hours)
|
5 Participants
|
—
|
|
Adverse Effects Following Immunization (AEFI) at the Age of 6 Months
Rash (in 48 hours)
|
1 Participants
|
—
|
|
Adverse Effects Following Immunization (AEFI) at the Age of 6 Months
No Vaccine Reaction reported (in 48 hours)
|
285 Participants
|
—
|
SECONDARY outcome
Timeframe: At 9 months and 11 months of agePopulation: This value is only available for infants who seroconverted and produced measurable IgG antibodies against 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.
Outcome measures
| Measure |
Group A:
n=297 Participants
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.)
|
Group B: Standard Dose
n=291 Participants
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.)
|
|---|---|---|
|
Immunogenicity at 9 Months - Measles
IgG at 9 months of age
|
914 mIU/mL
Interval 584.0 to 1353.0
|
—
|
|
Immunogenicity at 9 Months - Measles
IgG at 11 months of age
|
1453 mIU/mL
Interval 1057.0 to 2094.0
|
1311 mIU/mL
Interval 881.0 to 1976.0
|
SECONDARY outcome
Timeframe: At 9 months and 11 months of agePopulation: This value is only available for infants who seroconverted and produced measurable IgG antibodies against 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.
Outcome measures
| Measure |
Group A:
n=297 Participants
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.)
|
Group B: Standard Dose
n=291 Participants
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.)
|
|---|---|---|
|
Immunogenicity at 9 Months - Rubella
IgG at 9 months of age
|
102 IU/mL
Interval 59.0 to 166.0
|
—
|
|
Immunogenicity at 9 Months - Rubella
IgG at 11 months of age
|
94 IU/mL
Interval 60.0 to 137.0
|
155 IU/mL
Interval 91.0 to 228.0
|
SECONDARY outcome
Timeframe: Baseline enrollment (when infant was 6 months of age)To assess the distribution of mothers with undetectable, detectable and protective levels of measles and rubella immunoglobulin G (IgG) antibodies
Outcome measures
| Measure |
Group A:
n=301 Participants
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.)
|
Group B: Standard Dose
n=292 Participants
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.)
|
|---|---|---|
|
Measles and Rubella Titers of Enrolled Mothers
Measles IgG (Undetectable: <4mIU/mL; Protective: at least 153 mIU/mL) · Undetectable
|
0 Participants
|
0 Participants
|
|
Measles and Rubella Titers of Enrolled Mothers
Measles IgG (Undetectable: <4mIU/mL; Protective: at least 153 mIU/mL) · Detectable
|
46 Participants
|
37 Participants
|
|
Measles and Rubella Titers of Enrolled Mothers
Measles IgG (Undetectable: <4mIU/mL; Protective: at least 153 mIU/mL) · Protective
|
255 Participants
|
255 Participants
|
|
Measles and Rubella Titers of Enrolled Mothers
Rubella IgG (Undetectable: <0.08 IU/mL; Protective: at least 9·36 IU/mL) · Undetectable
|
0 Participants
|
0 Participants
|
|
Measles and Rubella Titers of Enrolled Mothers
Rubella IgG (Undetectable: <0.08 IU/mL; Protective: at least 9·36 IU/mL) · Detectable
|
52 Participants
|
53 Participants
|
|
Measles and Rubella Titers of Enrolled Mothers
Rubella IgG (Undetectable: <0.08 IU/mL; Protective: at least 9·36 IU/mL) · Protective
|
249 Participants
|
239 Participants
|
SECONDARY outcome
Timeframe: baseline (6 months infant age); 2nd blood draw (9 months of age) and 3rd blood draw (at 11 months of age)Population: This looks at the variation in the infant's antibody response overtime compared to a maternal baseline (a proxy for the infant's antibody level 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.
Outcome measures
| Measure |
Group A:
n=301 Participants
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.)
|
Group B: Standard Dose
n=292 Participants
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.)
|
|---|---|---|
|
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).
Measles baseline (6 months)
|
0.72 Pearson correlation coefficient (r)
|
0.66 Pearson correlation coefficient (r)
|
|
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).
Measles (9 months)
|
-0.26 Pearson correlation coefficient (r)
|
0.32 Pearson correlation coefficient (r)
|
|
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).
Measles (11 months)
|
-0.03 Pearson correlation coefficient (r)
|
0.02 Pearson correlation coefficient (r)
|
|
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).
Rubella baseline (6 months)
|
0.74 Pearson correlation coefficient (r)
|
0.74 Pearson correlation coefficient (r)
|
|
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).
Rubella (9 months)
|
-0.27 Pearson correlation coefficient (r)
|
0.51 Pearson correlation coefficient (r)
|
|
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).
Rubella (11 months)
|
-0.19 Pearson correlation coefficient (r)
|
-0.11 Pearson correlation coefficient (r)
|
SECONDARY outcome
Timeframe: Day 1 to day 84To estimate the half-life of decay of maternal measles and rubella antibodies in infants
Outcome measures
Outcome data not reported
Adverse Events
Group A: Early Dose
Serious events: 10 serious events
Other events: 38 other events
Deaths: 0 deaths
Group B: Standard Dose
Serious events: 7 serious events
Other events: 31 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Group A: Early Dose
n=312 participants at risk
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 and were not monitored for any adverse events.) After the 6-month vaccination, these participants also received a 48-hour safety monitoring visit at their home.
|
Group B: Standard Dose
n=308 participants at risk
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 and were not monitored for any adverse events.) \[Note: The infant death happened before any vaccine was given; and was excluded from study analyses.\]
|
|---|---|---|
|
Infections and infestations
Hospitalization: Respiratory Infections
|
1.6%
5/312 • Number of events 6 • Infants were assessed 0-30 minutes following immunization at the clinic, and parents were queried for adverse events at each subsequent study visit, up to 5 months in total duration. Arm A also received a safety monitoring visit at home 48 hours after immunization following the 6-month visit.
Only infants were assessed for adverse events. Additional exclusions are based on patient flow (eg. loss to follow-up, withdrawal of consent).
|
1.3%
4/308 • Number of events 4 • Infants were assessed 0-30 minutes following immunization at the clinic, and parents were queried for adverse events at each subsequent study visit, up to 5 months in total duration. Arm A also received a safety monitoring visit at home 48 hours after immunization following the 6-month visit.
Only infants were assessed for adverse events. Additional exclusions are based on patient flow (eg. loss to follow-up, withdrawal of consent).
|
|
Surgical and medical procedures
Surgical procedure
|
0.32%
1/312 • Number of events 1 • Infants were assessed 0-30 minutes following immunization at the clinic, and parents were queried for adverse events at each subsequent study visit, up to 5 months in total duration. Arm A also received a safety monitoring visit at home 48 hours after immunization following the 6-month visit.
Only infants were assessed for adverse events. Additional exclusions are based on patient flow (eg. loss to follow-up, withdrawal of consent).
|
0.32%
1/308 • Number of events 1 • Infants were assessed 0-30 minutes following immunization at the clinic, and parents were queried for adverse events at each subsequent study visit, up to 5 months in total duration. Arm A also received a safety monitoring visit at home 48 hours after immunization following the 6-month visit.
Only infants were assessed for adverse events. Additional exclusions are based on patient flow (eg. loss to follow-up, withdrawal of consent).
|
|
Infections and infestations
Hospitalization: other
|
1.9%
6/312 • Number of events 7 • Infants were assessed 0-30 minutes following immunization at the clinic, and parents were queried for adverse events at each subsequent study visit, up to 5 months in total duration. Arm A also received a safety monitoring visit at home 48 hours after immunization following the 6-month visit.
Only infants were assessed for adverse events. Additional exclusions are based on patient flow (eg. loss to follow-up, withdrawal of consent).
|
0.65%
2/308 • Number of events 2 • Infants were assessed 0-30 minutes following immunization at the clinic, and parents were queried for adverse events at each subsequent study visit, up to 5 months in total duration. Arm A also received a safety monitoring visit at home 48 hours after immunization following the 6-month visit.
Only infants were assessed for adverse events. Additional exclusions are based on patient flow (eg. loss to follow-up, withdrawal of consent).
|
|
Immune system disorders
Anaphylaxis
|
0.00%
0/312 • Infants were assessed 0-30 minutes following immunization at the clinic, and parents were queried for adverse events at each subsequent study visit, up to 5 months in total duration. Arm A also received a safety monitoring visit at home 48 hours after immunization following the 6-month visit.
Only infants were assessed for adverse events. Additional exclusions are based on patient flow (eg. loss to follow-up, withdrawal of consent).
|
0.00%
0/308 • Infants were assessed 0-30 minutes following immunization at the clinic, and parents were queried for adverse events at each subsequent study visit, up to 5 months in total duration. Arm A also received a safety monitoring visit at home 48 hours after immunization following the 6-month visit.
Only infants were assessed for adverse events. Additional exclusions are based on patient flow (eg. loss to follow-up, withdrawal of consent).
|
Other adverse events
| Measure |
Group A: Early Dose
n=312 participants at risk
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 and were not monitored for any adverse events.) After the 6-month vaccination, these participants also received a 48-hour safety monitoring visit at their home.
|
Group B: Standard Dose
n=308 participants at risk
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 and were not monitored for any adverse events.) \[Note: The infant death happened before any vaccine was given; and was excluded from study analyses.\]
|
|---|---|---|
|
Infections and infestations
Respiratory Infection
|
9.3%
29/312 • Number of events 30 • Infants were assessed 0-30 minutes following immunization at the clinic, and parents were queried for adverse events at each subsequent study visit, up to 5 months in total duration. Arm A also received a safety monitoring visit at home 48 hours after immunization following the 6-month visit.
Only infants were assessed for adverse events. Additional exclusions are based on patient flow (eg. loss to follow-up, withdrawal of consent).
|
8.1%
25/308 • Number of events 26 • Infants were assessed 0-30 minutes following immunization at the clinic, and parents were queried for adverse events at each subsequent study visit, up to 5 months in total duration. Arm A also received a safety monitoring visit at home 48 hours after immunization following the 6-month visit.
Only infants were assessed for adverse events. Additional exclusions are based on patient flow (eg. loss to follow-up, withdrawal of consent).
|
|
Infections and infestations
Diarrhea
|
2.2%
7/312 • Number of events 7 • Infants were assessed 0-30 minutes following immunization at the clinic, and parents were queried for adverse events at each subsequent study visit, up to 5 months in total duration. Arm A also received a safety monitoring visit at home 48 hours after immunization following the 6-month visit.
Only infants were assessed for adverse events. Additional exclusions are based on patient flow (eg. loss to follow-up, withdrawal of consent).
|
1.6%
5/308 • Number of events 5 • Infants were assessed 0-30 minutes following immunization at the clinic, and parents were queried for adverse events at each subsequent study visit, up to 5 months in total duration. Arm A also received a safety monitoring visit at home 48 hours after immunization following the 6-month visit.
Only infants were assessed for adverse events. Additional exclusions are based on patient flow (eg. loss to follow-up, withdrawal of consent).
|
|
Infections and infestations
Varicella (Chicken Pox)
|
1.9%
6/312 • Number of events 6 • Infants were assessed 0-30 minutes following immunization at the clinic, and parents were queried for adverse events at each subsequent study visit, up to 5 months in total duration. Arm A also received a safety monitoring visit at home 48 hours after immunization following the 6-month visit.
Only infants were assessed for adverse events. Additional exclusions are based on patient flow (eg. loss to follow-up, withdrawal of consent).
|
0.65%
2/308 • Number of events 2 • Infants were assessed 0-30 minutes following immunization at the clinic, and parents were queried for adverse events at each subsequent study visit, up to 5 months in total duration. Arm A also received a safety monitoring visit at home 48 hours after immunization following the 6-month visit.
Only infants were assessed for adverse events. Additional exclusions are based on patient flow (eg. loss to follow-up, withdrawal of consent).
|
Additional Information
Dr. Takudzwa SAYI
Centers for Disease Control and Prevention
Phone: 404-718-3797
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place