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Immunogenicity and Safety of Japanese Encephalitis Vaccine When Given With Measles-Mumps-Rubella (MMR) Vaccine

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ClinicalTrials.gov Identifier: NCT02880865
Recruitment Status : Completed
First Posted : August 26, 2016
Results First Posted : September 18, 2020
Last Update Posted : October 14, 2020
Sponsor:
Collaborators:
Research Institute for Tropical Medicine,
Syneos Health
DF/Net Research, Inc.
Information provided by (Responsible Party):
PATH

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Encephalitis, Japanese
Measles
Mumps
Rubella
Interventions Biological: Live attenuated SA 14-14-2 Japanese Encephalitis vaccine
Biological: Measles, mumps, rubella vaccine
Enrollment 628
Recruitment Details Participants were enrolled at 2 health centers in the Philippines.
Pre-assignment Details Filipino children aged 9 to < 10 months were randomized in a 1:1 ratio to receive measles, mumps, and rubella vaccine (MMR) and prequalified live, attenuated SA-14-4-2 Japanese encephalitis vaccine (CD-JEV) together (Group 1) or 56 days apart (Group 2). All participants received a second dose of MMR at 12 months of age.
Arm/Group Title Group 1: MMR and CD-JEV Group 2: MMR Then CD-JEV
Hide Arm/Group Description Participants received one dose of CD-JEV vaccine and one dose of MMR vaccine concurrently at Day 0. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age). Participants received one dose of MMR vaccine at Day 0 and one dose of CD-JEV 56 days later. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).
Period Title: Overall Study
Started 314 314
Received MMR Dose 1 314 314
Received CD-JEV 314 309
Received MMR Dose 2 313 311
Completed 313 311
Not Completed 1 3
Reason Not Completed
Adverse Event             1             0
Withdrawal by Subject             0             2
Physician Decision             0             1
Arm/Group Title Group 1: MMR and CD-JEV Group 2: MMR Then CD-JEV Total
Hide Arm/Group Description Participants received one dose of CD-JEV vaccine and one dose of MMR vaccine concurrently at Day 0. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age). Participants received one dose of MMR vaccine at Day 0 and one dose of CD-JEV 56 days later. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age). Total of all reporting groups
Overall Number of Baseline Participants 314 314 628
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Months
Number Analyzed 314 participants 314 participants 628 participants
9.2
(9.0 to 10.0)
9.2
(9.0 to 10.0)
9.2
(9.0 to 10.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 314 participants 314 participants 628 participants
Female
144
  45.9%
157
  50.0%
301
  47.9%
Male
170
  54.1%
157
  50.0%
327
  52.1%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Philippines Number Analyzed 314 participants 314 participants 628 participants
314 314 628
1.Primary Outcome
Title Percentage of Participants With Measles Seropositivity 56 Days Post-vaccination
Hide Description Measles immunogenicity was assessed by the percentage of participants with demonstrated seropositivity for measles at 56 days post-vaccination. Seropositivity was defined by a concentration of ≥ 120 mIU/mL of anti-measles neutralizing antibody titer, as measured by the plaque reduction neutralization test (PRNT) (dilution converted to concentration using the 3rd International Standard Reference serum).
Time Frame 56 days after MMR dose 1 vaccination (Day 56)
Hide Outcome Measure Data
Hide Analysis Population Description
The measles per-protocol population included participants who fulfilled the eligibility criteria, received all study vaccines as assigned, provided valid measles serology results at baseline and Day 56, did not take any prohibited concomitant medications within 28 days post-vaccination, and did not show measles seropositivity at baseline.
Arm/Group Title Group 1: MMR and CD-JEV Group 2: MMR Then CD-JEV
Hide Arm/Group Description:
Participants received one dose of CD-JEV vaccine and one dose of MMR vaccine concurrently at Day 0. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).
Participants received one dose of MMR vaccine at Day 0 and one dose of CD-JEV 56 days later. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).
Overall Number of Participants Analyzed 311 306
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
98.1
(95.8 to 99.3)
98.0
(95.8 to 99.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1: MMR and CD-JEV, Group 2: MMR Then CD-JEV
Comments The primary hypotheses evaluated the non-inferiority of the concomitant administration of MMR and CD-JEV vaccines (Group 1) to MMR and CD-JEV vaccines given 2 months apart (Group 2) in children 9 months of age at 56 days in terms of percentage of participants achieving seropositivity to measles and rubella assuming a non-inferiority margin of 10%.
Type of Statistical Test Non-Inferiority
Comments Non-inferiority was achieved if the lower limit of the two-sided 95% confidence interval (CI) for the difference in percentages of participants with seropositivity between the two groups (concurrent administration minus separate administration) at 56 days post-vaccination was > -10% for both measles and rubella results.
Method of Estimation Estimation Parameter Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-2.1 to 2.2
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percentage of Participants With Rubella Seropositivity 56 Days Post-vaccination
Hide Description Rubella immunogenicity was assessed by the percentage of participants with demonstrated seropositivity for rubella at 56 days post-vaccination. Seropositivity was defined as antirubella immunoglobulin G (IgG) concentration of ≥ 10 IU/mL (corresponding to an optical density ratio ≥ 1.10) using a commercial IgG enzyme-linked immunosorbent assay (ELISA).
Time Frame 56 days after MMR dose 1 vaccination (Day 56)
Hide Outcome Measure Data
Hide Analysis Population Description
The rubella per-protocol population included participants who fulfilled the eligibility criteria, received all study vaccines as assigned, provided valid rubella serology results at baseline and Day 56, did not take any prohibited concomitant medications within 28 days post-vaccination, and did not show rubella seropositivity at baseline.
Arm/Group Title Group 1: MMR and CD-JEV Group 2: MMR Then CD-JEV
Hide Arm/Group Description:
Participants received one dose of CD-JEV vaccine and one dose of MMR vaccine concurrently at Day 0. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).
Participants received one dose of MMR vaccine at Day 0 and one dose of CD-JEV 56 days later. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).
Overall Number of Participants Analyzed 285 295
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
100.0
(98.7 to 100.0)
99.7
(98.1 to 100.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1: MMR and CD-JEV, Group 2: MMR Then CD-JEV
Comments The primary hypotheses evaluated the non-inferiority of the concomitant administration of MMR and CD-JEV vaccines (Group 1) to MMR and CD-JEV vaccines given 2 months apart (Group 2) in children 9 months of age at 56 days in terms of percentage of participants achieving seropositivity to measles and rubella assuming a non-inferiority margin of 10%.
Type of Statistical Test Non-Inferiority
Comments Non-inferiority was achieved if the lower limit of the two-sided 95% CI for the difference in percentages of participants with seropositivity between the two groups (concurrent administration minus separate administration) at 56 days post-vaccination was > -10% for both measles and rubella results.
Method of Estimation Estimation Parameter Difference
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-0.3 to 1.0
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With Mumps Seropositivity 56 Days Post-vaccination
Hide Description Mumps immunogenicity was assessed by the percentage of participants with demonstrated seropositivity for mumps at 56 days post-vaccination. Seropositivity was defined as an optical density ratio ≥ 1.10 using a commercial ELISA.
Time Frame 56 days after MMR dose 1 vaccination (Day 56)
Hide Outcome Measure Data
Hide Analysis Population Description
The mumps per-protocol population included participants who fulfilled eligibility criteria, received all study vaccines as assigned, provided valid mumps serology results at baseline and Day 56, did not take any prohibited concomitant medications within within 28 days post-vaccination, and did not show mumps seropositivity at baseline.
Arm/Group Title Group 1: MMR and CD-JEV Group 2: MMR Then CD-JEV
Hide Arm/Group Description:
Participants received one dose of CD-JEV vaccine and one dose of MMR vaccine concurrently at Day 0. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).
Participants received one dose of MMR vaccine at Day 0 and one dose of CD-JEV 56 days later. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).
Overall Number of Participants Analyzed 270 265
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
98.5
(96.3 to 99.6)
98.5
(96.2 to 99.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1: MMR and CD-JEV, Group 2: MMR Then CD-JEV
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments The percentage of participants with seropositivity for mumps at 56 days post-vaccination between Group 1 and Group 2 were compared using a non-inferiority test. Non-inferiority of Group 1 to Group 2 in terms of seropositivity for mumps was demonstrated if the lower limit of the two-sided 95% CI for the difference of seropositivity rates between the two groups (concurrent administration minus separate administration) at 56 days post-vaccination was > -10%.
Method of Estimation Estimation Parameter Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-2.0 to 2.1
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Geometric Mean Concentration (GMC) for Anti-measles Neutralizing Antibody Concentration at 56 Days Post-vaccination
Hide Description Anti-measles neutralizing antibody concentration was measured by the plaque reduction neutralization test (PRNT).
Time Frame 56 days after MMR dose 1 vaccination (Day 56)
Hide Outcome Measure Data
Hide Analysis Population Description
The measles per-protocol population included participants who fulfilled the eligibility criteria, received all study vaccines as assigned, provided valid measles serology results at baseline and Day 56, did not take any prohibited concomitant medications within 28 days post-vaccination, and did not show measles seropositivity at baseline.
Arm/Group Title Group 1: MMR and CD-JEV Group 2: MMR Then CD-JEV
Hide Arm/Group Description:
Participants received one dose of CD-JEV vaccine and one dose of MMR vaccine concurrently at Day 0. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).
Participants received one dose of MMR vaccine at Day 0 and one dose of CD-JEV 56 days later. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).
Overall Number of Participants Analyzed 311 306
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
1964.4
(1769.3 to 2181.0)
1866.3
(1649.1 to 2112.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1: MMR and CD-JEV, Group 2: MMR Then CD-JEV
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMC Ratio
Estimated Value 1.1
Confidence Interval (2-Sided) 95%
0.9 to 1.2
Estimation Comments Group 1/Group 2 ratio obtained using analysis of covariance (ANCOVA) with log10-transformed antibody concentration as dependent variable and treatment group as the explanatory variable adjusted for log10-transformed baseline antibody concentration.
5.Secondary Outcome
Title GMC for Anti-rubella IgG Antibody Concentration at 56 Days Post-vaccination
Hide Description Anti-rubella immunoglobulin G (IgG) concentration was measured using a commercial IgG enzyme-linked immunosorbent assay (ELISA).
Time Frame 56 days after MMR dose 1 vaccination (Day 56)
Hide Outcome Measure Data
Hide Analysis Population Description
The rubella per-protocol population included participants who fulfilled the eligibility criteria, received all study vaccines as assigned, provided valid rubella serology results at baseline and Day 56, did not take any prohibited concomitant medications within 28 days post-vaccination, and did not show rubella seropositivity at baseline.
Arm/Group Title Group 1: MMR and CD-JEV Group 2: MMR Then CD-JEV
Hide Arm/Group Description:
Participants received one dose of CD-JEV vaccine and one dose of MMR vaccine concurrently at Day 0. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).
Participants received one dose of MMR vaccine at Day 0 and one dose of CD-JEV 56 days later. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).
Overall Number of Participants Analyzed 285 295
Geometric Mean (95% Confidence Interval)
Unit of Measure: IU/mL
230.8
(214.4 to 248.5)
229.8
(210.0 to 251.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1: MMR and CD-JEV, Group 2: MMR Then CD-JEV
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMC Ratio
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
0.9 to 1.1
Estimation Comments Group 1/Group 2 ratio obtained using an ANCOVA method with log 10-transformed antibody concentration as dependent variable and treatment group as explanatory variable adjusted for log 10-transformed baseline antibody concentration.
6.Secondary Outcome
Title Seroconversion Rate for Measles 56 Days Post-vaccination
Hide Description The seroconversion rate for measles at 56 days post-vaccination was defined as the percentage of participants with a change in serostatus from negative to positive 56 days after vaccination or a four-fold rise in concentration 56 days after vaccination if seropositive for measles at baseline. Seropositivity was defined by a concentration of ≥ 120 mIU/mL of anti-measles neutralizing antibody titer, as measured by the plaque reduction neutralization test (PRNT).
Time Frame 56 days after MMR dose 1 vaccination (Day 56)
Hide Outcome Measure Data
Hide Analysis Population Description
The measles per-protocol population included participants who fulfilled the eligibility criteria, received all study vaccines as assigned, provided valid measles serology results at baseline and Day 56, did not take any prohibited concomitant medications within 28 days post-vaccination, and did not show measles seropositivity at baseline.
Arm/Group Title Group 1: MMR and CD-JEV Group 2: MMR Then CD-JEV
Hide Arm/Group Description:
Participants received one dose of CD-JEV vaccine and one dose of MMR vaccine concurrently at Day 0. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).
Participants received one dose of MMR vaccine at Day 0 and one dose of CD-JEV 56 days later. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).
Overall Number of Participants Analyzed 311 306
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
98.1
(95.8 to 99.3)
98.0
(95.8 to 99.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1: MMR and CD-JEV, Group 2: MMR Then CD-JEV
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-2.1 to 2.2
Estimation Comments Group 1 - Group 2
7.Secondary Outcome
Title Seroconversion Rate for Mumps 56 Days Post-vaccination
Hide Description The seroconversion rate for mumps at 56 days post-vaccination was defined as the percentage of participants with a change in serostatus from negative to positive 56 days after vaccination. Seropositivity was defined as an optical density ratio ≥ 1.10, measured using a commercial ELISA. Participants with equivocal serostatus at baseline are counted as non-responders.
Time Frame 56 days after MMR dose 1 vaccination (Day 56)
Hide Outcome Measure Data
Hide Analysis Population Description
The mumps per-protocol population included participants who fulfilled eligibility criteria, received all study vaccines as assigned, provided valid mumps serology results at baseline and Day 56, did not take any prohibited concomitant medications within within 28 days post-vaccination, and did not show mumps seropositivity at baseline.
Arm/Group Title Group 1: MMR and CD-JEV Group 2: MMR Then CD-JEV
Hide Arm/Group Description:
Participants received one dose of CD-JEV vaccine and one dose of MMR vaccine concurrently at Day 0. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).
Participants received one dose of MMR vaccine at Day 0 and one dose of CD-JEV 56 days later. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).
Overall Number of Participants Analyzed 270 265
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
96.7
(93.8 to 98.5)
95.1
(91.8 to 97.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1: MMR and CD-JEV, Group 2: MMR Then CD-JEV
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 1.6
Confidence Interval (2-Sided) 95%
-1.8 to 4.9
Estimation Comments Group 1 - Group 2
8.Secondary Outcome
Title Seroconversion Rate for Rubella 56 Days Post-vaccination
Hide Description The seroconversion rate for rubella at 56 days post-vaccination was defined as the percentage of participants with a change in serostatus from negative to positive 56 days after vaccination or a four-fold rise in concentration 56 days after vaccination if seropositive for rubella at baseline. Seropositivity is defined as a post-vaccination concentration of ≥ 10 IU/mL measured using a commercial ELISA.
Time Frame 56 days after MMR dose 1 vaccination (Day 56)
Hide Outcome Measure Data
Hide Analysis Population Description
The rubella per-protocol population included participants who fulfilled the eligibility criteria, received all study vaccines as assigned, provided valid rubella serology results at baseline and Day 56, did not take any prohibited concomitant medications within 28 days post-vaccination, and did not show rubella seropositivity at baseline.
Arm/Group Title Group 1: MMR and CD-JEV Group 2: MMR Then CD-JEV
Hide Arm/Group Description:
Participants received one dose of CD-JEV vaccine and one dose of MMR vaccine concurrently at Day 0. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).
Participants received one dose of MMR vaccine at Day 0 and one dose of CD-JEV 56 days later. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).
Overall Number of Participants Analyzed 285 295
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
100.0
(98.7 to 100.0)
99.7
(98.1 to 100.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1: MMR and CD-JEV, Group 2: MMR Then CD-JEV
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-0.3 to 1.0
Estimation Comments Group 1 - Group 2
9.Secondary Outcome
Title Percentage of Participants With Japanese Encephalitis Seropositivity 28 Days Post-vaccination
Hide Description Japanese encephalitis (JE) immunogenicity was assessed by the percentage of participants with demonstrated seropositivity 28 days after CD-JEV vaccination. Seropositivity was defined as an anti-JE serum neutralizing antibody titer of ≥ 1:10, as measured by JE PRNT-50.
Time Frame 28 days after CD-JEV vaccination (Day 28 for Group 1 and Day 84 for Group 2)
Hide Outcome Measure Data
Hide Analysis Population Description
The JE per-protocol population included participants who fulfilled eligibility criteria, received all study vaccines as assigned, provided valid JE serology results at baseline and 28 days post-vaccination with CD-JEV, did not take any prohibited concomitant medications within 28 days post-vaccination, and did not show JE seropositivity at baseline
Arm/Group Title Group 1: MMR and CD-JEV Group 2: MMR Then CD-JEV
Hide Arm/Group Description:
Participants received one dose of CD-JEV vaccine and one dose of MMR vaccine concurrently at Day 0. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).
Participants received one dose of MMR vaccine at Day 0 and one dose of CD-JEV 56 days later. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).
Overall Number of Participants Analyzed 314 305
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
72.3
(67.0 to 77.2)
68.2
(62.6 to 73.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1: MMR and CD-JEV, Group 2: MMR Then CD-JEV
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 4.1
Confidence Interval (2-Sided) 95%
-3.1 to 11.3
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Geometric Mean Titer (GMT) for Serum Neutralizing Antibody Titer to JE Virus at 28 Days Post-vaccination
Hide Description Anti-JE serum neutralizing antibody titer was measured using JE PRNT-50.
Time Frame 28 days after CD-JEV vaccination (Day 28 for Group 1 and Day 84 for Group 2)
Hide Outcome Measure Data
Hide Analysis Population Description
The JE per-protocol population included participants who fulfilled eligibility criteria, received all study vaccines as assigned, provided valid JE serology results at baseline and 28 days post-vaccination with CD-JEV, did not take any prohibited concomitant medications within 28 days post-vaccination, and did not show JE seropositivity at baseline
Arm/Group Title Group 1 - MMR and CD-JEV Group 2 - MMR Then CD-JEV
Hide Arm/Group Description:
Participants received one dose of CD-JEV vaccine and one dose of MMR vaccine concurrently at Day 0; Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).
Participants received one dose of MMR vaccine at Day 0 and one dose of CD-JEV 56 days later. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).
Overall Number of Participants Analyzed 314 305
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
24.0
(20.8 to 27.6)
20.3
(17.8 to 23.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1 - MMR and CD-JEV, Group 2 - MMR Then CD-JEV
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 1.2
Confidence Interval (2-Sided) 95%
1.0 to 1.4
Estimation Comments Group 1 / Group 2 ratio obtained using an analysis of covariance (ANCOVA) method with log 10-transformed antibody concentration as dependent variable and treatment group as explanatory variable adjusted for log 10-transformed baseline antibody titer.
11.Secondary Outcome
Title Number of Participants With Immediate Reactions Within 30 Minutes of Each Vaccination
Hide Description

Participants were observed for 30 minutes after each vaccination for immediate reactions. Immediate reactions included both local (injection site) and systemic reactions. MMR vaccine was injected on left upper thigh and CD-JEV was injected on right upper thigh.

Serious reactions were those meeting one of the following conditions:

  • Death.
  • Life threatening
  • Required inpatient hospitalization or prolongation of existing hospitalization.
  • Resulted in a persistent or significant disability or incapacity.
  • Important medical events that, based upon appropriate medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed above.
Time Frame 30 minutes following each study vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all participants who received a study vaccine and had at least one safety measure post-vaccination.
Arm/Group Title Group 1: MMR Dose 1 + CD-JEV Group 2: MMR Dose 1 Group 2: CD-JEV Group 1: MMR Dose 2 Group 2: MMR Dose 2
Hide Arm/Group Description:
Participants in Group 1 received one dose of CD-JEV vaccine and one dose of MMR vaccine concurrently on Day 0.
Participants in Group 2 received one dose of MMR vaccine on Day 0.
Participants in Group 2 received one dose of CD-JEV on Day 56.
Participants in Group 1 received a second dose of MMR vaccine on Day 84.
Participants in Group 2 received a second dose of MMR vaccine on Day 84.
Overall Number of Participants Analyzed 314 314 309 313 311
Measure Type: Count of Participants
Unit of Measure: Participants
Any immediate reaction Number Analyzed 314 participants 314 participants 309 participants 313 participants 311 participants
6
   1.9%
3
   1.0%
5
   1.6%
5
   1.6%
3
   1.0%
MMR local reaction Number Analyzed 314 participants 314 participants 0 participants 313 participants 311 participants
3
   1.0%
2
   0.6%
3
   1.0%
1
   0.3%
CD-JEV local reaction Number Analyzed 314 participants 0 participants 309 participants 0 participants 0 participants
3
   1.0%
4
   1.3%
Systemic Number Analyzed 314 participants 314 participants 309 participants 313 participants 311 participants
1
   0.3%
1
   0.3%
1
   0.3%
1
   0.3%
2
   0.6%
Serious reactions Number Analyzed 314 participants 314 participants 309 participants 313 participants 311 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
12.Secondary Outcome
Title Number of Participants With Solicited Local and Systemic Reactions Within 14 Days of Each Vaccination
Hide Description

Reactogenicity post-vaccination was assessed from 30 minutes through 14 days following vaccination.

Parents used a structured reactogenicity diary card to record the following solicited (pre-listed) local and system reactions.

Local reactions (at injection site):

  • Ecchymosis (bruising)
  • Erythema (redness)
  • Edema (swelling)
  • Induration (hardness)
  • Pain/tenderness

Systemic reactions:

  • Fever
  • Rash
  • Cough
  • Runny nose
  • Change in eating habits
  • Diarrhea
  • Sleepiness
  • Irritability
  • Unusual crying
  • Vomiting
Time Frame 30 minutes through 14 days following each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Group 1: MMR Dose 1 + CD-JEV Group 2: MMR Dose 1 Group 2: CD-JEV Group 1: MMR Dose 2 Group 2: MMR Dose 2
Hide Arm/Group Description:
Participants in Group 1 received one dose of CD-JEV vaccine and one dose of MMR vaccine concurrently on Day 0.
Participants in Group 2 received one dose of MMR vaccine on Day 0.
Participants in Group 2 received one dose of CD-JEV on Day 56.
Participants in Group 1 received a second dose of MMR vaccine on Day 84.
Participants in Group 2 received a second dose of MMR vaccine on Day 84.
Overall Number of Participants Analyzed 314 314 309 313 311
Measure Type: Count of Participants
Unit of Measure: Participants
Any local reactions at MMR injection site Number Analyzed 314 participants 314 participants 0 participants 313 participants 311 participants
35
  11.1%
31
   9.9%
12
   3.8%
9
   2.9%
Any local reactions at CD-JEV injection site Number Analyzed 314 participants 0 participants 309 participants 0 participants 0 participants
34
  10.8%
13
   4.2%
Any systemic reactions Number Analyzed 314 participants 314 participants 309 participants 313 participants 311 participants
224
  71.3%
222
  70.7%
190
  61.5%
168
  53.7%
174
  55.9%
13.Secondary Outcome
Title Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity
Hide Description

Parents recorded local reactions on a diary card.

Local ecchymosis, erythema, edema, and induration were graded as follows:

Grade 1: ≤2.5 cm in diameter.

Grade 2: >2.5 cm in diameter with 50% of surface area of extremity segment involved.

Grade 3: ≥50% surface area of extremity segment involved OR ulceration OR secondary infection OR phlebitis OR sterile abscess OR drainage.

Grade 4: potentially life-threatening (e.g., abscess, exfoliative dermatitis, necrosis involving dermis or deeper tissue).

Injection site pain/tenderness (pain without touching or tenderness when the area is touched) were graded as follows:

Grade 1: pain/tenderness causing no or minimal limitation of use of limb. Grade 2: pain/tenderness causing greater than minimal limitation of use of limb.

Grade 3: pain/tenderness causing inability to perform usual social and functional activities.

Grade 4: pain/tenderness causing inability to perform basic self-care OR hospitalization indicated.

Time Frame 30 minutes through 14 days following each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Group 1: MMR Dose 1 Group 1: CD-JEV Group 2: MMR Dose 1 Group 2: CD-JEV Group 1: MMR Dose 2 Group 2: MMR Dose 2
Hide Arm/Group Description:
Participants in Group 1 received one dose of MMR vaccine injected on the left upper thigh on Day 0.
Participants in Group 1 received one dose of CD-JEV vaccine injected on the right upper thigh on Day 0.
Participants in Group 2 received one dose of MMR vaccine injected on the left upper thigh on Day 0.
Participants in Group 2 received one dose of CD-JEV vaccine injected on the left upper thigh on Day 56.
Participants in Group 1 received a 2nd dose of MMR vaccine injected on the left upper thigh on Day 84.
Participants in Group 2 received a 2nd dose of MMR vaccine injected on the left upper thigh on Day 84.
Overall Number of Participants Analyzed 314 314 314 309 313 311
Measure Type: Count of Participants
Unit of Measure: Participants
Ecchymosis: Any
6
   1.9%
6
   1.9%
10
   3.2%
3
   1.0%
0
   0.0%
5
   1.6%
Ecchymosis: Grade 1
6
   1.9%
6
   1.9%
10
   3.2%
3
   1.0%
0
   0.0%
5
   1.6%
Ecchymosis: Grade 2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Ecchymosis: Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Ecchymosis: Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Erythema: Any
15
   4.8%
13
   4.1%
14
   4.5%
8
   2.6%
5
   1.6%
7
   2.3%
Erythema: Grade 1
15
   4.8%
12
   3.8%
14
   4.5%
8
   2.6%
5
   1.6%
7
   2.3%
Erythema: Grade 2
0
   0.0%
1
   0.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Erythema: Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Erythema: Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Edema: Any
6
   1.9%
3
   1.0%
7
   2.2%
5
   1.6%
0
   0.0%
4
   1.3%
Edema: Grade 1
5
   1.6%
3
   1.0%
7
   2.2%
5
   1.6%
0
   0.0%
4
   1.3%
Edema: Grade 2
1
   0.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Edema: Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Edema: Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Induration: Any
4
   1.3%
7
   2.2%
7
   2.2%
4
   1.3%
0
   0.0%
3
   1.0%
Induration: Grade 1
4
   1.3%
6
   1.9%
7
   2.2%
4
   1.3%
0
   0.0%
3
   1.0%
Induration: Grade 2
0
   0.0%
1
   0.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Induration: Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Induration: Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Pain/Tenderness: Any
18
   5.7%
18
   5.7%
19
   6.1%
6
   1.9%
8
   2.6%
5
   1.6%
Pain/Tenderness: Grade 1
17
   5.4%
17
   5.4%
17
   5.4%
5
   1.6%
8
   2.6%
4
   1.3%
Pain/Tenderness: Grade 2
1
   0.3%
1
   0.3%
2
   0.6%
1
   0.3%
0
   0.0%
1
   0.3%
Pain/Tenderness: Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Pain/Tenderness: Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
14.Secondary Outcome
Title Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity
Hide Description

Parents recorded systemic reactions on a diary card.

Fever was recorded and graded as follows (axillary temperature):

Grade 1: 37.5°C to 37.9°C

Grade 2: 38.0°C to 38.4°C

Grade 3: 38.5°C to 40.0°C

Grade 4: >40.0°C

Rash, cough, runny nose, change in eating habits, diarrhea, sleepiness, irritability, unusual crying, vomiting, and any other unsolicited reaction occurring from 30 minutes through 14 days post vaccination were graded as follows:

Grade 1: symptoms causing no or minimal interference with usual social and functional activities.

Grade 2: symptoms causing greater than minimal interference with usual social and functional activities.

Grade 3: symptoms causing inability to perform usual social and functional activities with intervention or hospitalization indicated.

Grade 4: symptoms causing inability to perform basic self-care functions OR medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death.

Time Frame 30 minutes through 14 days following each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Group 1: MMR Dose 1 + CD-JEV Group 2: MMR Dose 1 Group 2: CD-JEV Group 1: MMR Dose 2 Group 2: MMR Dose 2
Hide Arm/Group Description:
Participants in Group 1 received one dose of MMR vaccine and one dose of CD-JEV concurrently on Day 0.
Participants in Group 2 received one dose of MMR vaccine on Day 0.
Participants in Group 2 received one dose of CD-JEV vaccine on Day 56.
Participants in Group 1 received a second dose of MMR vaccine on Day 84.
Participants in Group 2 received a second dose of MMR vaccine on Day 84.
Overall Number of Participants Analyzed 314 314 309 313 311
Measure Type: Count of Participants
Unit of Measure: Participants
Fever: Any
135
  43.0%
119
  37.9%
87
  28.2%
79
  25.2%
84
  27.0%
Fever: Grade 1
52
  16.6%
35
  11.1%
39
  12.6%
31
   9.9%
25
   8.0%
Fever: Grade 2
38
  12.1%
43
  13.7%
21
   6.8%
23
   7.3%
26
   8.4%
Fever: Grade 3
44
  14.0%
40
  12.7%
26
   8.4%
25
   8.0%
32
  10.3%
Fever: Grade 4
1
   0.3%
1
   0.3%
1
   0.3%
0
   0.0%
1
   0.3%
Rash: Any
27
   8.6%
33
  10.5%
13
   4.2%
19
   6.1%
18
   5.8%
Rash: Grade 1
23
   7.3%
28
   8.9%
12
   3.9%
16
   5.1%
16
   5.1%
Rash: Grade 2
3
   1.0%
4
   1.3%
1
   0.3%
2
   0.6%
2
   0.6%
Rash: Grade 3
0
   0.0%
1
   0.3%
0
   0.0%
0
   0.0%
0
   0.0%
Rash: Grade 4
1
   0.3%
0
   0.0%
0
   0.0%
1
   0.3%
0
   0.0%
Cough: Any
127
  40.4%
116
  36.9%
118
  38.2%
111
  35.5%
103
  33.1%
Cough: Grade 1
103
  32.8%
92
  29.3%
98
  31.7%
95
  30.4%
90
  28.9%
Cough: Grade 2
20
   6.4%
22
   7.0%
18
   5.8%
16
   5.1%
13
   4.2%
Cough: Grade 3
4
   1.3%
2
   0.6%
2
   0.6%
0
   0.0%
0
   0.0%
Cough: Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Runny nose: Any
167
  53.2%
163
  51.9%
143
  46.3%
133
  42.5%
135
  43.4%
Runny nose: Grade 1
139
  44.3%
138
  43.9%
128
  41.4%
117
  37.4%
119
  38.3%
Runny nose: Grade 2
26
   8.3%
23
   7.3%
14
   4.5%
14
   4.5%
16
   5.1%
Runny nose: Grade 3
2
   0.6%
2
   0.6%
1
   0.3%
2
   0.6%
0
   0.0%
Runny nose: Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Change in eating habits: Any
49
  15.6%
32
  10.2%
27
   8.7%
36
  11.5%
27
   8.7%
Change in eating habits: Grade 1
40
  12.7%
25
   8.0%
23
   7.4%
29
   9.3%
21
   6.8%
Change in eating habits: Grade 2
9
   2.9%
6
   1.9%
4
   1.3%
6
   1.9%
5
   1.6%
Change in eating habits: Grade 3
0
   0.0%
1
   0.3%
0
   0.0%
1
   0.3%
1
   0.3%
Change in eating habits: Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Diarrhea: Any
58
  18.5%
49
  15.6%
29
   9.4%
34
  10.9%
36
  11.6%
Diarrhea: Grade 1
49
  15.6%
45
  14.3%
23
   7.4%
30
   9.6%
25
   8.0%
Diarrhea: Grade 2
7
   2.2%
2
   0.6%
5
   1.6%
1
   0.3%
9
   2.9%
Diarrhea: Grade 3
1
   0.3%
0
   0.0%
1
   0.3%
2
   0.6%
1
   0.3%
Diarrhea: Grade 4
1
   0.3%
2
   0.6%
0
   0.0%
1
   0.3%
1
   0.3%
Sleepiness: Any
43
  13.7%
32
  10.2%
12
   3.9%
15
   4.8%
16
   5.1%
Sleepiness: Grade 1
39
  12.4%
29
   9.2%
12
   3.9%
15
   4.8%
15
   4.8%
Sleepiness: Grade 2
4
   1.3%
3
   1.0%
0
   0.0%
0
   0.0%
1
   0.3%
Sleepiness: Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sleepiness: Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Irritability: Any
80
  25.5%
63
  20.1%
36
  11.7%
46
  14.7%
33
  10.6%
Irritability: Grade 1
63
  20.1%
51
  16.2%
32
  10.4%
40
  12.8%
30
   9.6%
Irritability: Grade 2
14
   4.5%
10
   3.2%
4
   1.3%
4
   1.3%
2
   0.6%
Irritability: Grade 3
3
   1.0%
2
   0.6%
0
   0.0%
2
   0.6%
1
   0.3%
Irritability: Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unusual crying: Any
54
  17.2%
29
   9.2%
20
   6.5%
29
   9.3%
20
   6.4%
Unusual crying: Grade 1
45
  14.3%
23
   7.3%
17
   5.5%
24
   7.7%
16
   5.1%
Unusual crying: Grade 2
8
   2.5%
5
   1.6%
3
   1.0%
5
   1.6%
3
   1.0%
Unusual crying: Grade 3
1
   0.3%
1
   0.3%
0
   0.0%
0
   0.0%
1
   0.3%
Unusual crying: Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Vomiting: Any grade
29
   9.2%
26
   8.3%
21
   6.8%
22
   7.0%
31
  10.0%
Vomiting: Grade 1
25
   8.0%
18
   5.7%
17
   5.5%
16
   5.1%
20
   6.4%
Vomiting: Grade 2
4
   1.3%
8
   2.5%
4
   1.3%
3
   1.0%
9
   2.9%
Vomiting Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
2
   0.6%
1
   0.3%
Vomiting: Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.3%
1
   0.3%
15.Secondary Outcome
Title Number of Participants With Unsolicited Adverse Events Within 28 Days of Each Vaccination
Hide Description

Each adverse event (AE) was assessed for relationship to vaccine by the study clinician according to the following:

Definitely Related: An adverse event or unanticipated problem clearly related to the research procedures.

Possibly Related: There is a reasonable possibility that the adverse event or unanticipated problem, incident, experience, or outcome may have been caused by the procedures involved in the research.

Not Related: Any adverse event or unanticipated problem clearly not related to study procedures.

Related adverse events includes events that were assessed as definitely or possibly related.

Time Frame 28 days following each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Group 1: MMR Dose 1 + CD-JEV Group 2: MMR Dose 1 Group 2: CD-JEV Group 1: MMR Dose 2 Group 2: MMR Dose 2
Hide Arm/Group Description:
Participants in Group 1 received one dose of CD-JEV vaccine and one dose of MMR vaccine concurrently on Day 0.
Participants in Group 2 received one dose of MMR vaccine at Day 0.
Participants in Group 2 received one dose of CD-JEV on Day 56.
Participants in Group 1 received a second dose of MMR vaccine on Day 84.
Participants in Group 2 received a second dose of MMR vaccine on Day 84.
Overall Number of Participants Analyzed 314 314 309 313 311
Measure Type: Count of Participants
Unit of Measure: Participants
Any adverse event
207
  65.9%
211
  67.2%
164
  53.1%
110
  35.1%
148
  47.6%
Related adverse events
35
  11.1%
22
   7.0%
20
   6.5%
22
   7.0%
30
   9.6%
16.Secondary Outcome
Title Number of Participants With Serious Adverse Events Throughout the Study
Hide Description

A serious adverse event (SAE) was defined as an AE that met one of the following:

  • Death
  • Life threatening
  • Required inpatient hospitalization or prolongation of existing hospitalization
  • Resulted in persistent or significant disability or incapacity
  • Important medical events that, based upon appropriate medical judgment, jeopardized the participant and required medical or surgical intervention to prevent an outcomes listed above

AEs were assessed for relationship to vaccine by the study clinician according to the following:

Definitely Related: An AE or unanticipated problem clearly related to the research procedures.

Possibly Related: There is a reasonable possibility that the AE or unanticipated problem, incident, experience, or outcome may have been caused by the procedures involved in the research.

Not Related: Any AE or unanticipated problem clearly not related to study procedures.

Related SAEs includes events that were assessed as definitely or possibly related.

Time Frame Up to 112 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Group 1: MMR and CD-JEV Group 2: MMR Then CD-JEV
Hide Arm/Group Description:
Participants received one dose of CD-JEV vaccine and one dose of MMR vaccine concurrently on Day 0. Participants received a second dose of MMR per the routine immunization schedule on Day 84 (12 months of age).
Participants received one dose of MMR vaccine on Day 0 and one dose of CD-JEV 56 days later. Participants received a second dose of MMR per the routine immunization schedule on Day 84 (12 months of age).
Overall Number of Participants Analyzed 314 314
Measure Type: Count of Participants
Unit of Measure: Participants
Any serious adverse event
8
   2.5%
15
   4.8%
Related serious adverse event
0
   0.0%
0
   0.0%
Time Frame Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1: MMR Dose 1 + CD-JEV Group 2: MMR Dose 1 Group 2: CD-JEV Group 1: MMR Dose 2 Group 2: MMR Dose 2
Hide Arm/Group Description Participants in Group 1 received one dose of CD-JEV vaccine and one dose of MMR vaccine concurrently on Day 0. Participants in Group 2 received one dose of MMR vaccine at Day 0. Participants in Group 2 received one dose of CD-JEV on Day 56. Participants in Group 1 received a second dose of MMR vaccine on Day 84. Participants in Group 2 received a second dose of MMR vaccine on Day 84.
All-Cause Mortality
Group 1: MMR Dose 1 + CD-JEV Group 2: MMR Dose 1 Group 2: CD-JEV Group 1: MMR Dose 2 Group 2: MMR Dose 2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/314 (0.00%)      0/314 (0.00%)      0/309 (0.00%)      0/313 (0.00%)      0/311 (0.00%)    
Hide Serious Adverse Events
Group 1: MMR Dose 1 + CD-JEV Group 2: MMR Dose 1 Group 2: CD-JEV Group 1: MMR Dose 2 Group 2: MMR Dose 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/314 (1.91%)      12/314 (3.82%)      3/309 (0.97%)      2/313 (0.64%)      1/311 (0.32%)    
Infections and infestations           
Amoebiasis  1  0/314 (0.00%)  3/314 (0.96%)  0/309 (0.00%)  0 0/313 (0.00%)  0/311 (0.00%) 
Bronchitis  1  0/314 (0.00%)  1/314 (0.32%)  0/309 (0.00%)  0/313 (0.00%)  0/311 (0.00%) 
Gastroenteritis  1  5/314 (1.59%)  3/314 (0.96%)  1/309 (0.32%)  2/313 (0.64%)  0/311 (0.00%) 
Urinary tract infection  1  0/314 (0.00%)  1/314 (0.32%)  0/309 (0.00%)  0/313 (0.00%)  0/311 (0.00%) 
Pneumonia  1  0/314 (0.00%)  3/314 (0.96%)  2/309 (0.65%)  0/313 (0.00%)  1/311 (0.32%) 
Metabolism and nutrition disorders           
Food intolerance  1  0/314 (0.00%)  1/314 (0.32%)  0/309 (0.00%)  0/313 (0.00%)  0/311 (0.00%) 
Nervous system disorders           
Febrile convulsion  1  1/314 (0.32%)  0/314 (0.00%)  0/309 (0.00%)  0/313 (0.00%)  0/311 (0.00%) 
1
Term from vocabulary, MedDRA 19.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group 1: MMR Dose 1 + CD-JEV Group 2: MMR Dose 1 Group 2: CD-JEV Group 1: MMR Dose 2 Group 2: MMR Dose 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   207/314 (65.92%)      211/314 (67.20%)      164/309 (53.07%)      110/313 (35.14%)      147/311 (47.27%)    
Blood and lymphatic system disorders           
Lymphadenopathy  1  0/314 (0.00%)  1/314 (0.32%)  0/309 (0.00%)  0/313 (0.00%)  0/311 (0.00%) 
Iron deficiency anaemia  2  0/314 (0.00%)  0/314 (0.00%)  0/309 (0.00%)  0/313 (0.00%)  1/311 (0.32%) 
Eye disorders           
Blepharitis  1  1/314 (0.32%)  0/314 (0.00%)  0/309 (0.00%)  0/313 (0.00%)  0/311 (0.00%) 
Gastrointestinal disorders           
Aphthous ulcer  2  1/314 (0.32%)  1/314 (0.32%)  1/309 (0.32%)  0/313 (0.00%)  1/311 (0.32%) 
Abdominal pain  2  1/314 (0.32%)  0/314 (0.00%)  0/309 (0.00%)  0/313 (0.00%)  0/311 (0.00%) 
Constipation  2  0/314 (0.00%)  0/314 (0.00%)  1/309 (0.32%)  0/313 (0.00%)  0/311 (0.00%) 
Dyspepsia  2  0/314 (0.00%)  1/314 (0.32%)  0/309 (0.00%)  0/313 (0.00%)  0/311 (0.00%) 
Stomatitis  2  2/314 (0.64%)  0/314 (0.00%)  0/309 (0.00%)  0/313 (0.00%)  0/311 (0.00%) 
Teething  2  1/314 (0.32%)  2/314 (0.64%)  2/309 (0.65%)  0/313 (0.00%)  0/311 (0.00%) 
Vomiting  2  1/314 (0.32%)  0/314 (0.00%)  0/309 (0.00%)  0/313 (0.00%)  0/311 (0.00%) 
General disorders           
Pyrexia  2  4/314 (1.27%)  2/314 (0.64%)  5/309 (1.62%)  8/313 (2.56%)  5/311 (1.61%) 
Injection site induration  2  1/314 (0.32%)  0/314 (0.00%)  0/309 (0.00%)  0/313 (0.00%)  0/311 (0.00%) 
Immune system disorders           
Allergy to arthropod sting  2  0/314 (0.00%)  0/314 (0.00%)  0/309 (0.00%)  0/313 (0.00%)  1/311 (0.32%) 
Hypersensitivity  2  4/314 (1.27%)  2/314 (0.64%)  1/309 (0.32%)  2/313 (0.64%)  0/311 (0.00%) 
Food allergy  2  0/314 (0.00%)  1/314 (0.32%)  0/309 (0.00%)  0/313 (0.00%)  0/311 (0.00%) 
Infections and infestations           
Abscess  2  0/314 (0.00%)  0/314 (0.00%)  2/309 (0.65%)  0/313 (0.00%)  0/311 (0.00%) 
Body tinea  2  1/314 (0.32%)  0/314 (0.00%)  0/309 (0.00%)  1/313 (0.32%)  0/311 (0.00%) 
Bronchiolitis  2  1/314 (0.32%)  5/314 (1.59%)  0/309 (0.00%)  2/313 (0.64%)  2/311 (0.64%) 
Bronchitis  2  16/314 (5.10%)  24/314 (7.64%)  20/309 (6.47%)  13/313 (4.15%)  15/311 (4.82%) 
Bullous impetigo  2  0/314 (0.00%)  1/314 (0.32%)  1/309 (0.32%)  0/313 (0.00%)  0/311 (0.00%) 
Carbuncle  2  0/314 (0.00%)  1/314 (0.32%)  2/309 (0.65%)  2/313 (0.64%)  1/311 (0.32%) 
Conjunctivitis  2  0/314 (0.00%)  4/314 (1.27%)  1/309 (0.32%)  3/313 (0.96%)  1/311 (0.32%) 
Cellulitis orbital  2  1/314 (0.32%)  0/314 (0.00%)  0/309 (0.00%)  0/313 (0.00%)  0/311 (0.00%) 
Conjunctivitis bacterial  2  0/314 (0.00%)  0/314 (0.00%)  0/309 (0.00%)  1/313 (0.32%)  0/311 (0.00%) 
Conjunctivitis viral  2  0/314 (0.00%)  0/314 (0.00%)  0/309 (0.00%)  1/313 (0.32%)  0/311 (0.00%) 
Dermatitis infected  2  2/314 (0.64%)  0/314 (0.00%)  0/309 (0.00%)  0/313 (0.00%)  0/311 (0.00%) 
Exanthema subitum  2  5/314 (1.59%)  6/314 (1.91%)  1/309 (0.32%)  2/313 (0.64%)  2/311 (0.64%) 
Erythema infectiosum  2  0/314 (0.00%)  1/314 (0.32%)  0/309 (0.00%)  0/313 (0.00%)  0/311 (0.00%) 
Folliculitis  2  2/314 (0.64%)  1/314 (0.32%)  0/309 (0.00%)  1/313 (0.32%)  0/311 (0.00%) 
Gastroenteritis  2  31/314 (9.87%)  22/314 (7.01%)  19/309 (6.15%)  10/313 (3.19%)  24/311 (7.72%) 
Gastroenteritis viral  2  2/314 (0.64%)  0/314 (0.00%)  0/309 (0.00%)  0/313 (0.00%)  0/311 (0.00%) 
Hand-foot-and-mouth disease  2  2/314 (0.64%)  6/314 (1.91%)  8/309 (2.59%)  5/313 (1.60%)  1/311 (0.32%) 
Herpangina  2  1/314 (0.32%)  0/314 (0.00%)  0/309 (0.00%)  0/313 (0.00%)  0/311 (0.00%) 
Hordeolum  2  1/314 (0.32%)  0/314 (0.00%)  1/309 (0.32%)  0/313 (0.00%)  1/311 (0.32%) 
Impetigo  2  6/314 (1.91%)  1/314 (0.32%)  4/309 (1.29%)  1/313 (0.32%)  1/311 (0.32%) 
Ludwig angina  2  0/314 (0.00%)  0/314 (0.00%)  1/309 (0.32%)  1/313 (0.32%)  0/311 (0.00%) 
Nasopharyngitis  2  21/314 (6.69%)  19/314 (6.05%)  16/309 (5.18%)  5/313 (1.60%)  13/311 (4.18%) 
Oral candidiasis  2  0/314 (0.00%)  1/314 (0.32%)  2/309 (0.65%)  0/313 (0.00%)  2/311 (0.64%) 
Otitis media  2  1/314 (0.32%)  0/314 (0.00%)  0/309 (0.00%)  1/313 (0.32%)  1/311 (0.32%) 
Otitis externa  1  0/314 (0.00%)  1/314 (0.32%)  0/309 (0.00%)  0/313 (0.00%)  0/311 (0.00%) 
Otitis media acute  2  2/314 (0.64%)  1/314 (0.32%)  3/309 (0.97%)  1/313 (0.32%)  0/311 (0.00%) 
Parasitic gastroenteritis  2  0/314 (0.00%)  2/314 (0.64%)  0/309 (0.00%)  0/313 (0.00%)  0/311 (0.00%) 
Pharyngotonsillitis  2  2/314 (0.64%)  3/314 (0.96%)  1/309 (0.32%)  2/313 (0.64%)  2/311 (0.64%) 
Pneumonia  2  11/314 (3.50%)  9/314 (2.87%)  6/309 (1.94%)  9/313 (2.88%)  5/311 (1.61%) 
Respiratory tract infection  2  1/314 (0.32%)  1/314 (0.32%)  1/309 (0.32%)  1/313 (0.32%)  0/311 (0.00%) 
Rhinitis  2  31/314 (9.87%)  39/314 (12.42%)  34/309 (11.00%)  17/313 (5.43%)  21/311 (6.75%) 
Roseola  2  0/314 (0.00%)  1/314 (0.32%)  0/309 (0.00%)  0/313 (0.00%)  0/311 (0.00%) 
Subcutaneous abscess  2  0/314 (0.00%)  0/314 (0.00%)  0/309 (0.00%)  1/313 (0.32%)  0/311 (0.00%) 
Tinea cruris  2  1/314 (0.32%)  0/314 (0.00%)  0/309 (0.00%)  0/313 (0.00%)  0/311 (0.00%) 
Tinea versicolour  2  1/314 (0.32%)  1/314 (0.32%)  2/309 (0.65%)  0/313 (0.00%)  0/311 (0.00%) 
Upper respiratory tract infection  2  76/314 (24.20%)  77/314 (24.52%)  54/309 (17.48%)  40/313 (12.78%)  62/311 (19.94%) 
Upper respiratory tract infection bacterial  2  6/314 (1.91%)  4/314 (1.27%)  2/309 (0.65%)  0/313 (0.00%)  0/311 (0.00%) 
Urinary tract infection  2  2/314 (0.64%)  0/314 (0.00%)  2/309 (0.65%)  1/313 (0.32%)  3/311 (0.96%) 
Varicella  2  2/314 (0.64%)  4/314 (1.27%)  3/309 (0.97%)  1/313 (0.32%)  0/311 (0.00%) 
Viral infection  2  24/314 (7.64%)  21/314 (6.69%)  12/309 (3.88%)  8/313 (2.56%)  6/311 (1.93%) 
Viral rash  2  5/314 (1.59%)  5/314 (1.59%)  0/309 (0.00%)  0/313 (0.00%)  4/311 (1.29%) 
Viral upper respiratory tract infection  2  8/314 (2.55%)  9/314 (2.87%)  1/309 (0.32%)  0/313 (0.00%)  0/311 (0.00%) 
Wound infection  2  6/314 (1.91%)  3/314 (0.96%)  3/309 (0.97%)  3/313 (0.96%)  1/311 (0.32%) 
Injury, poisoning and procedural complications           
Anal injury  2  0/314 (0.00%)  1/314 (0.32%)  0/309 (0.00%)  0/313 (0.00%)  0/311 (0.00%) 
Animal bite  2  0/314 (0.00%)  1/314 (0.32%)  0/309 (0.00%)  0/313 (0.00%)  0/311 (0.00%) 
Arthropod bite  2  0/314 (0.00%)  0/314 (0.00%)  2/309 (0.65%)  0/313 (0.00%)  0/311 (0.00%) 
Burns second degree  2  1/314 (0.32%)  0/314 (0.00%)  0/309 (0.00%)  0/313 (0.00%)  0/311 (0.00%) 
Contusion  2  3/314 (0.96%)  0/314 (0.00%)  0/309 (0.00%)  0/313 (0.00%)  0/311 (0.00%) 
Head injury  2  1/314 (0.32%)  0/314 (0.00%)  0/309 (0.00%)  0/313 (0.00%)  0/311 (0.00%) 
Skin abrasion  2  2/314 (0.64%)  0/314 (0.00%)  0/309 (0.00%)  0/313 (0.00%)  0/311 (0.00%) 
Thermal burn  2  1/314 (0.32%)  0/314 (0.00%)  0/309 (0.00%)  0/313 (0.00%)  0/311 (0.00%) 
Wound  2  0/314 (0.00%)  0/314 (0.00%)  0/309 (0.00%)  0/313 (0.00%)  1/311 (0.32%) 
Metabolism and nutrition disorders           
Food intolerance  2  0/314 (0.00%)  1/314 (0.32%)  1/309 (0.32%)  0/313 (0.00%)  0/311 (0.00%) 
Hypokalaemia  2  0/314 (0.00%)  0/314 (0.00%)  0/309 (0.00%)  0/313 (0.00%)  1/311 (0.32%) 
Irritability  2  1/314 (0.32%)  0/314 (0.00%)  0/309 (0.00%)  0/313 (0.00%)  0/311 (0.00%) 
Nervous system disorders           
Febrile convulsion  2  0/314 (0.00%)  0/314 (0.00%)  0/309 (0.00%)  1/313 (0.32%)  0/311 (0.00%) 
Psychiatric disorders           
Breath holding  2  0/314 (0.00%)  0/314 (0.00%)  0/309 (0.00%)  1/313 (0.32%)  0/311 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Allergic cough  2  0/314 (0.00%)  0/314 (0.00%)  2/309 (0.65%)  2/313 (0.64%)  1/311 (0.32%) 
Bronchial hyperreactivity  2  0/314 (0.00%)  1/314 (0.32%)  1/309 (0.32%)  1/313 (0.32%)  2/311 (0.64%) 
Epistaxis  2  0/314 (0.00%)  0/314 (0.00%)  0/309 (0.00%)  1/313 (0.32%)  0/311 (0.00%) 
Rhinitis allergic  2  2/314 (0.64%)  2/314 (0.64%)  2/309 (0.65%)  1/313 (0.32%)  4/311 (1.29%) 
Skin and subcutaneous tissue disorders           
Dermatitis  2  0/314 (0.00%)  0/314 (0.00%)  0/309 (0.00%)  0/313 (0.00%)  1/311 (0.32%) 
Dermatitis allergic  1  0/314 (0.00%)  1/314 (0.32%)  0/309 (0.00%)  0/313 (0.00%)  0/311 (0.00%) 
Dermatitis atopic  1  0/314 (0.00%)  0/314 (0.00%)  1/309 (0.32%)  0/313 (0.00%)  0/311 (0.00%) 
Dermatitis contact  2  1/314 (0.32%)  1/314 (0.32%)  1/309 (0.32%)  2/313 (0.64%)  0/311 (0.00%) 
Dermatitis diaper  2  1/314 (0.32%)  3/314 (0.96%)  3/309 (0.97%)  2/313 (0.64%)  2/311 (0.64%) 
Miliaria  2  1/314 (0.32%)  1/314 (0.32%)  1/309 (0.32%)  1/313 (0.32%)  3/311 (0.96%) 
Seborrhoeic dermatitis  2  0/314 (0.00%)  2/314 (0.64%)  0/309 (0.00%)  0/313 (0.00%)  0/311 (0.00%) 
Skin hyperpigmentation  2  0/314 (0.00%)  0/314 (0.00%)  0/309 (0.00%)  1/313 (0.32%)  0/311 (0.00%) 
Urticaria  2  0/314 (0.00%)  0/314 (0.00%)  0/309 (0.00%)  1/313 (0.32%)  0/311 (0.00%) 
1
Term from vocabulary, MedDRA
2
Term from vocabulary, MedDRA 19.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jorge Flores, MD
Organization: PATH
Phone: (202) 822-0033
EMail: jeflores@path.org
Layout table for additonal information
Responsible Party: PATH
ClinicalTrials.gov Identifier: NCT02880865    
Other Study ID Numbers: JEV06
PHRR160822-001339 ( Registry Identifier: Philippine Health Research Registry (PHRR) )
First Submitted: August 17, 2016
First Posted: August 26, 2016
Results First Submitted: August 27, 2020
Results First Posted: September 18, 2020
Last Update Posted: October 14, 2020