Encephalitis, Japanese, Measles, Mumps, Rubella
Conditions
Keywords
vaccine
Brief summary
This study aims to provide evidence that co-administration of measles-mumps-rubella vaccine (MMR) and live attenuated SA 14-14-2 Japanese encephalitis vaccine (CD-JEV) does not adversely affect immunogenicity or safety.
Detailed description
When incorporating a new vaccine in the Expanded Programme on Immunization (EPI), it is important to provide evidence that it can be introduced concurrently with other routine pediatric vaccines without significantly impairing the immune response to any vaccine while maximizing coverage and minimizing cost. This non-inferiority study aims to compare CD-JEV and MMR responses in a population of children in a country where MMR introduction is ongoing or planned. This information will help the ministries of health evaluate the addition of CD-JEV into routine EPI.
Interventions
BIOLOGICALLive attenuated SA 14-14-2 Japanese Encephalitis vaccine
Single 0.5 mL dose of World Health Organization prequalified live, attenuated SA 14-14-2 JE vaccine manufactured by Chengdu Institute of Biological Products, Chengdu, China, administered by subcutaneous injection
BIOLOGICALMeasles, mumps, rubella vaccine
Single 0.5 mL dose of live, attenuated measles-mumps-rubella vaccine (Schwarz measles virus, RIT 4385 mumps strain, and Wistar RA 27/3 rubella virus) manufactured by GlaxoSmithKline, Inc., administered by subcutaneous injection.
Sponsors
Research Institute for Tropical Medicine
Syneos Health
DFNet Research Inc.
PATH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Months to 9 Months
Healthy volunteers
Yes
Inclusion criteria
* Age 9 months to \< 10 months at the time of enrollment. * Residence in the study area. * At least one parent or guardian willing to provide written informed consent. * Generally healthy and free of obvious health problems as established by medical history, physical examination, and clinical judgment. * A parent or guardian is willing to attend all planned study visits and allow home visits and phone contacts, as required by the protocol.
Exclusion criteria
* Previous receipt of any measles-mumps-rubella containing vaccine. * Previous receipt of any Japanese encephalitis vaccine. * History of measles, mumps, rubella, or Japanese encephalitis infection. * Administration of any other vaccine within 28 days prior to administration of a study vaccine or planned vaccination of any vaccine other than catch-up doses of routine EPI vaccines or oral polio vaccine during the 28 days after study vaccination. * History of allergic disease or known hypersensitivity to any component of the study vaccines and/or following administration of vaccines included in the local program of immunization. * Use of any investigational or non-registered drug within 90 days prior to the administration of study vaccines or planned administration during the study period. * Administration of immunoglobulins and/or any blood products within 90 days prior to the administration of study vaccines or planned administration during the study period. * Chronic administration (defined as \> 7 days) of immunosuppressing or other immune-modifying agents within 14 days before or after vaccination (including systemic corticosteroids equivalent to prednisone ≥ 0.5 mg/kg/day; topical and inhaled steroids are allowed). * Primary or acquired immunodeficiency, including human immunodeficiency virus (HIV) infection, or a family history of congenital or hereditary immunodeficiency as reported by parent. * Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by medical history or physical examination, which might interfere with the study objectives. * Severely malnourished infants as measured by World Health Organization weight-for-height tables (Z-score \< -3). * Any condition or criterion that, in the opinion of the study physician, might compromise the well-being of the participant, compliance with study procedures, or interpretation of the outcomes of the study. * Acute illness at the time of enrollment defined as the presence of a moderate or severe illness with fever (axillary temperature ≥ 38.0°C) or without fever (severity determined at the discretion of the study physician). Acute illness is a temporary exclusion. Vaccination should be postponed at least 7 days after recovery. A visit for reassessment may be scheduled 7 days or more after temporary exclusion illness is resolved. Eligibility for study participation must be reassessed again at the next visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Measles Seropositivity 56 Days Post-vaccination | 56 days after MMR dose 1 vaccination (Day 56) | 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). |
| Percentage of Participants With Rubella Seropositivity 56 Days Post-vaccination | 56 days after MMR dose 1 vaccination (Day 56) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GMC for Anti-rubella IgG Antibody Concentration at 56 Days Post-vaccination | 56 days after MMR dose 1 vaccination (Day 56) | Anti-rubella immunoglobulin G (IgG) concentration was measured using a commercial IgG enzyme-linked immunosorbent assay (ELISA). |
| Seroconversion Rate for Measles 56 Days Post-vaccination | 56 days after MMR dose 1 vaccination (Day 56) | 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). |
| Seroconversion Rate for Mumps 56 Days Post-vaccination | 56 days after MMR dose 1 vaccination (Day 56) | 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. |
| Seroconversion Rate for Rubella 56 Days Post-vaccination | 56 days after MMR dose 1 vaccination (Day 56) | 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. |
| Percentage of Participants With Japanese Encephalitis Seropositivity 28 Days Post-vaccination | 28 days after CD-JEV vaccination (Day 28 for Group 1 and Day 84 for Group 2) | 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. |
| Geometric Mean Titer (GMT) for Serum Neutralizing Antibody Titer to JE Virus at 28 Days Post-vaccination | 28 days after CD-JEV vaccination (Day 28 for Group 1 and Day 84 for Group 2) | Anti-JE serum neutralizing antibody titer was measured using JE PRNT-50. |
| Percentage of Participants With Mumps Seropositivity 56 Days Post-vaccination | 56 days after MMR dose 1 vaccination (Day 56) | 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. |
| Number of Participants With Solicited Local and Systemic Reactions Within 14 Days of Each Vaccination | 30 minutes through 14 days following each vaccination | 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 |
| Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | 30 minutes through 14 days following each vaccination | 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. |
| Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | 30 minutes through 14 days following each vaccination | 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. |
| Number of Participants With Unsolicited Adverse Events Within 28 Days of Each Vaccination | 28 days following each vaccination | 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. |
| Number of Participants With Serious Adverse Events Throughout the Study | Up to 112 days | 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. |
| Number of Participants With Immediate Reactions Within 30 Minutes of Each Vaccination | 30 minutes following each study vaccination | 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. |
| Geometric Mean Concentration (GMC) for Anti-measles Neutralizing Antibody Concentration at 56 Days Post-vaccination | 56 days after MMR dose 1 vaccination (Day 56) | Anti-measles neutralizing antibody concentration was measured by the plaque reduction neutralization test (PRNT). |
Countries
Philippines
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Group 1: MMR and CD-JEV 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). | 314 |
| Group 2: MMR Then CD-JEV 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). | 314 |
| Total | 628 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Group 2: MMR Then CD-JEV | Total | Group 1: MMR and CD-JEV |
|---|---|---|---|
| Age, Continuous | 9.2 months | 9.2 months | 9.2 months |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Philippines | 314 participants | 628 participants | 314 participants |
| Sex: Female, Male Female | 157 Participants | 301 Participants | 144 Participants |
| Sex: Female, Male Male | 157 Participants | 327 Participants | 170 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 314 | 0 / 314 | 0 / 309 | 0 / 313 | 0 / 311 |
| other Total, other adverse events | 207 / 314 | 211 / 314 | 164 / 309 | 110 / 313 | 147 / 311 |
| serious Total, serious adverse events | 6 / 314 | 12 / 314 | 3 / 309 | 2 / 313 | 1 / 311 |
Outcome results
Primary
Percentage of Participants With Measles Seropositivity 56 Days Post-vaccination
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)
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: MMR and CD-JEV | Percentage of Participants With Measles Seropositivity 56 Days Post-vaccination | 98.1 percentage of participants |
| Group 2: MMR Then CD-JEV | Percentage of Participants With Measles Seropositivity 56 Days Post-vaccination | 98.0 percentage of participants |
Comparison: 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%.95% CI: [-2.1, 2.2]
Primary
Percentage of Participants With Rubella Seropositivity 56 Days Post-vaccination
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)
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: MMR and CD-JEV | Percentage of Participants With Rubella Seropositivity 56 Days Post-vaccination | 100.0 percentage of participants |
| Group 2: MMR Then CD-JEV | Percentage of Participants With Rubella Seropositivity 56 Days Post-vaccination | 99.7 percentage of participants |
Comparison: 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%.95% CI: [-0.3, 1]
Secondary
Geometric Mean Concentration (GMC) for Anti-measles Neutralizing Antibody Concentration at 56 Days Post-vaccination
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)
Population: 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 | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: MMR and CD-JEV | Geometric Mean Concentration (GMC) for Anti-measles Neutralizing Antibody Concentration at 56 Days Post-vaccination | 1964.4 mIU/mL |
| Group 2: MMR Then CD-JEV | Geometric Mean Concentration (GMC) for Anti-measles Neutralizing Antibody Concentration at 56 Days Post-vaccination | 1866.3 mIU/mL |
95% CI: [0.9, 1.2]
Secondary
Geometric Mean Titer (GMT) for Serum Neutralizing Antibody Titer to JE Virus at 28 Days Post-vaccination
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)
Population: 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 | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: MMR and CD-JEV | Geometric Mean Titer (GMT) for Serum Neutralizing Antibody Titer to JE Virus at 28 Days Post-vaccination | 24.0 titer |
| Group 2: MMR Then CD-JEV | Geometric Mean Titer (GMT) for Serum Neutralizing Antibody Titer to JE Virus at 28 Days Post-vaccination | 20.3 titer |
95% CI: [1, 1.4]
Secondary
GMC for Anti-rubella IgG Antibody Concentration at 56 Days Post-vaccination
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)
Population: 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 | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: MMR and CD-JEV | GMC for Anti-rubella IgG Antibody Concentration at 56 Days Post-vaccination | 230.8 IU/mL |
| Group 2: MMR Then CD-JEV | GMC for Anti-rubella IgG Antibody Concentration at 56 Days Post-vaccination | 229.8 IU/mL |
95% CI: [0.9, 1.1]
Secondary
Number of Participants With Immediate Reactions Within 30 Minutes of Each Vaccination
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
Population: The safety population included all participants who received a study vaccine and had at least one safety measure post-vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: MMR and CD-JEV | Number of Participants With Immediate Reactions Within 30 Minutes of Each Vaccination | Systemic | 1 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Immediate Reactions Within 30 Minutes of Each Vaccination | Any immediate reaction | 6 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Immediate Reactions Within 30 Minutes of Each Vaccination | Serious reactions | 0 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Immediate Reactions Within 30 Minutes of Each Vaccination | MMR local reaction | 3 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Immediate Reactions Within 30 Minutes of Each Vaccination | CD-JEV local reaction | 3 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Immediate Reactions Within 30 Minutes of Each Vaccination | Systemic | 1 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Immediate Reactions Within 30 Minutes of Each Vaccination | Any immediate reaction | 3 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Immediate Reactions Within 30 Minutes of Each Vaccination | Serious reactions | 0 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Immediate Reactions Within 30 Minutes of Each Vaccination | MMR local reaction | 2 Participants |
| Group 2: CD-JEV | Number of Participants With Immediate Reactions Within 30 Minutes of Each Vaccination | CD-JEV local reaction | 4 Participants |
| Group 2: CD-JEV | Number of Participants With Immediate Reactions Within 30 Minutes of Each Vaccination | Any immediate reaction | 5 Participants |
| Group 2: CD-JEV | Number of Participants With Immediate Reactions Within 30 Minutes of Each Vaccination | Systemic | 1 Participants |
| Group 2: CD-JEV | Number of Participants With Immediate Reactions Within 30 Minutes of Each Vaccination | Serious reactions | 0 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Immediate Reactions Within 30 Minutes of Each Vaccination | MMR local reaction | 3 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Immediate Reactions Within 30 Minutes of Each Vaccination | Systemic | 1 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Immediate Reactions Within 30 Minutes of Each Vaccination | Any immediate reaction | 5 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Immediate Reactions Within 30 Minutes of Each Vaccination | Serious reactions | 0 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Immediate Reactions Within 30 Minutes of Each Vaccination | MMR local reaction | 1 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Immediate Reactions Within 30 Minutes of Each Vaccination | Serious reactions | 0 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Immediate Reactions Within 30 Minutes of Each Vaccination | Systemic | 2 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Immediate Reactions Within 30 Minutes of Each Vaccination | Any immediate reaction | 3 Participants |
Secondary
Number of Participants With Serious Adverse Events Throughout the Study
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
Population: Safety population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: MMR and CD-JEV | Number of Participants With Serious Adverse Events Throughout the Study | Any serious adverse event | 8 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Serious Adverse Events Throughout the Study | Related serious adverse event | 0 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Serious Adverse Events Throughout the Study | Any serious adverse event | 15 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Serious Adverse Events Throughout the Study | Related serious adverse event | 0 Participants |
Secondary
Number of Participants With Solicited Local and Systemic Reactions Within 14 Days of Each Vaccination
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
Population: Safety population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: MMR and CD-JEV | Number of Participants With Solicited Local and Systemic Reactions Within 14 Days of Each Vaccination | Any local reactions at MMR injection site | 35 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Solicited Local and Systemic Reactions Within 14 Days of Each Vaccination | Any systemic reactions | 224 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Solicited Local and Systemic Reactions Within 14 Days of Each Vaccination | Any local reactions at CD-JEV injection site | 34 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Solicited Local and Systemic Reactions Within 14 Days of Each Vaccination | Any local reactions at MMR injection site | 31 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Solicited Local and Systemic Reactions Within 14 Days of Each Vaccination | Any systemic reactions | 222 Participants |
| Group 2: CD-JEV | Number of Participants With Solicited Local and Systemic Reactions Within 14 Days of Each Vaccination | Any local reactions at CD-JEV injection site | 13 Participants |
| Group 2: CD-JEV | Number of Participants With Solicited Local and Systemic Reactions Within 14 Days of Each Vaccination | Any systemic reactions | 190 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Solicited Local and Systemic Reactions Within 14 Days of Each Vaccination | Any local reactions at MMR injection site | 12 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Solicited Local and Systemic Reactions Within 14 Days of Each Vaccination | Any systemic reactions | 168 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Solicited Local and Systemic Reactions Within 14 Days of Each Vaccination | Any systemic reactions | 174 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Solicited Local and Systemic Reactions Within 14 Days of Each Vaccination | Any local reactions at MMR injection site | 9 Participants |
Secondary
Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity
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
Population: Safety population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: MMR and CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Ecchymosis: Grade 3 | 0 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Edema: Grade 3 | 0 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Induration: Grade 1 | 4 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Ecchymosis: Any | 6 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Edema: Grade 4 | 0 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Induration: Any | 4 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Pain/Tenderness: Grade 3 | 0 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Ecchymosis: Grade 4 | 0 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Pain/Tenderness: Grade 2 | 1 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Erythema: Any | 15 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Ecchymosis: Grade 1 | 6 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Pain/Tenderness: Grade 1 | 17 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Erythema: Grade 1 | 15 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Erythema: Grade 2 | 0 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Pain/Tenderness: Any | 18 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Erythema: Grade 3 | 0 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Induration: Grade 4 | 0 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Erythema: Grade 4 | 0 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Pain/Tenderness: Grade 4 | 0 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Edema: Any | 6 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Induration: Grade 3 | 0 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Edema: Grade 1 | 5 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Ecchymosis: Grade 2 | 0 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Induration: Grade 2 | 0 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Edema: Grade 2 | 1 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Erythema: Grade 1 | 12 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Pain/Tenderness: Grade 4 | 0 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Induration: Grade 3 | 0 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Erythema: Any | 13 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Pain/Tenderness: Grade 1 | 17 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Edema: Any | 3 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Ecchymosis: Grade 4 | 0 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Ecchymosis: Grade 1 | 6 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Pain/Tenderness: Any | 18 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Erythema: Grade 2 | 1 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Induration: Grade 2 | 1 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Erythema: Grade 3 | 0 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Induration: Grade 1 | 6 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Edema: Grade 3 | 0 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Induration: Grade 4 | 0 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Edema: Grade 2 | 0 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Edema: Grade 1 | 3 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Edema: Grade 4 | 0 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Ecchymosis: Any | 6 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Induration: Any | 7 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Erythema: Grade 4 | 0 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Pain/Tenderness: Grade 3 | 0 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Ecchymosis: Grade 2 | 0 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Ecchymosis: Grade 3 | 0 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Pain/Tenderness: Grade 2 | 1 Participants |
| Group 2: CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Erythema: Grade 3 | 0 Participants |
| Group 2: CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Ecchymosis: Grade 4 | 0 Participants |
| Group 2: CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Induration: Grade 1 | 7 Participants |
| Group 2: CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Induration: Grade 3 | 0 Participants |
| Group 2: CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Pain/Tenderness: Grade 1 | 17 Participants |
| Group 2: CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Pain/Tenderness: Grade 2 | 2 Participants |
| Group 2: CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Ecchymosis: Any | 10 Participants |
| Group 2: CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Erythema: Any | 14 Participants |
| Group 2: CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Edema: Grade 2 | 0 Participants |
| Group 2: CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Induration: Any | 7 Participants |
| Group 2: CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Edema: Grade 3 | 0 Participants |
| Group 2: CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Edema: Any | 7 Participants |
| Group 2: CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Ecchymosis: Grade 2 | 0 Participants |
| Group 2: CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Erythema: Grade 1 | 14 Participants |
| Group 2: CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Edema: Grade 1 | 7 Participants |
| Group 2: CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Pain/Tenderness: Any | 19 Participants |
| Group 2: CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Ecchymosis: Grade 3 | 0 Participants |
| Group 2: CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Pain/Tenderness: Grade 3 | 0 Participants |
| Group 2: CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Pain/Tenderness: Grade 4 | 0 Participants |
| Group 2: CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Erythema: Grade 2 | 0 Participants |
| Group 2: CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Ecchymosis: Grade 1 | 10 Participants |
| Group 2: CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Erythema: Grade 4 | 0 Participants |
| Group 2: CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Induration: Grade 4 | 0 Participants |
| Group 2: CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Induration: Grade 2 | 0 Participants |
| Group 2: CD-JEV | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Edema: Grade 4 | 0 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Induration: Any | 4 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Ecchymosis: Any | 3 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Ecchymosis: Grade 1 | 3 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Ecchymosis: Grade 2 | 0 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Ecchymosis: Grade 3 | 0 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Ecchymosis: Grade 4 | 0 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Erythema: Any | 8 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Erythema: Grade 1 | 8 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Erythema: Grade 2 | 0 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Erythema: Grade 3 | 0 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Erythema: Grade 4 | 0 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Edema: Any | 5 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Edema: Grade 1 | 5 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Edema: Grade 2 | 0 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Edema: Grade 3 | 0 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Edema: Grade 4 | 0 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Induration: Grade 1 | 4 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Induration: Grade 2 | 0 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Induration: Grade 3 | 0 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Induration: Grade 4 | 0 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Pain/Tenderness: Any | 6 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Pain/Tenderness: Grade 1 | 5 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Pain/Tenderness: Grade 2 | 1 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Pain/Tenderness: Grade 3 | 0 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Pain/Tenderness: Grade 4 | 0 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Edema: Grade 1 | 0 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Edema: Any | 0 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Erythema: Any | 5 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Erythema: Grade 3 | 0 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Ecchymosis: Any | 0 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Pain/Tenderness: Grade 1 | 8 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Pain/Tenderness: Grade 3 | 0 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Ecchymosis: Grade 4 | 0 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Ecchymosis: Grade 1 | 0 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Ecchymosis: Grade 3 | 0 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Induration: Grade 4 | 0 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Pain/Tenderness: Grade 2 | 0 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Erythema: Grade 4 | 0 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Erythema: Grade 2 | 0 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Ecchymosis: Grade 2 | 0 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Induration: Grade 2 | 0 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Erythema: Grade 1 | 5 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Edema: Grade 4 | 0 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Induration: Grade 1 | 0 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Induration: Any | 0 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Induration: Grade 3 | 0 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Edema: Grade 3 | 0 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Pain/Tenderness: Any | 8 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Edema: Grade 2 | 0 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Pain/Tenderness: Grade 4 | 0 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Edema: Grade 3 | 0 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Induration: Grade 1 | 3 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Edema: Grade 1 | 4 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Edema: Any | 4 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Induration: Grade 2 | 0 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Erythema: Grade 4 | 0 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Pain/Tenderness: Grade 3 | 0 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Induration: Grade 3 | 0 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Erythema: Grade 3 | 0 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Erythema: Grade 2 | 0 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Induration: Grade 4 | 0 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Erythema: Grade 1 | 7 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Ecchymosis: Any | 5 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Pain/Tenderness: Any | 5 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Erythema: Any | 7 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Ecchymosis: Grade 4 | 0 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Pain/Tenderness: Grade 1 | 4 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Ecchymosis: Grade 3 | 0 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Pain/Tenderness: Grade 4 | 0 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Pain/Tenderness: Grade 2 | 1 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Ecchymosis: Grade 2 | 0 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Ecchymosis: Grade 1 | 5 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Edema: Grade 4 | 0 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Induration: Any | 3 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity | Edema: Grade 2 | 0 Participants |
Secondary
Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity
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
Population: Safety population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: MMR and CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Cough: Any | 127 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Fever: Grade 2 | 38 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Runny nose: Grade 4 | 0 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Runny nose: Grade 3 | 2 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Runny nose: Grade 2 | 26 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Cough: Grade 1 | 103 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Vomiting Grade 3 | 0 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Runny nose: Grade 1 | 139 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Runny nose: Any | 167 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Cough: Grade 4 | 0 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Cough: Grade 2 | 20 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Unusual crying: Grade 3 | 1 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Cough: Grade 3 | 4 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Unusual crying: Grade 2 | 8 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Unusual crying: Grade 1 | 45 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Fever: Grade 3 | 44 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Vomiting: Grade 2 | 4 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Unusual crying: Any | 54 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Irritability: Grade 4 | 0 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Irritability: Grade 3 | 3 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Fever: Grade 4 | 1 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Fever: Grade 1 | 52 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Irritability: Grade 2 | 14 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Irritability: Grade 1 | 63 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Irritability: Any | 80 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Rash: Any | 27 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Vomiting: Grade 4 | 0 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Sleepiness: Grade 4 | 0 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Sleepiness: Grade 3 | 0 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Sleepiness: Grade 2 | 4 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Rash: Grade 1 | 23 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Fever: Any | 135 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Sleepiness: Grade 1 | 39 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Sleepiness: Any | 43 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Diarrhea: Grade 4 | 1 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Rash: Grade 2 | 3 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Vomiting: Grade 1 | 25 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Diarrhea: Grade 3 | 1 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Diarrhea: Grade 2 | 7 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Diarrhea: Grade 1 | 49 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Rash: Grade 3 | 0 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Vomiting: Any grade | 29 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Diarrhea: Any | 58 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Change in eating habits: Grade 4 | 0 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Change in eating habits: Grade 3 | 0 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Rash: Grade 4 | 1 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Unusual crying: Grade 4 | 0 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Change in eating habits: Grade 2 | 9 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Change in eating habits: Grade 1 | 40 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Change in eating habits: Any | 49 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Rash: Grade 1 | 28 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Fever: Any | 119 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Fever: Grade 1 | 35 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Fever: Grade 2 | 43 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Fever: Grade 3 | 40 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Fever: Grade 4 | 1 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Rash: Any | 33 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Rash: Grade 2 | 4 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Rash: Grade 3 | 1 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Rash: Grade 4 | 0 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Cough: Any | 116 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Cough: Grade 1 | 92 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Cough: Grade 2 | 22 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Cough: Grade 3 | 2 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Cough: Grade 4 | 0 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Runny nose: Any | 163 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Runny nose: Grade 1 | 138 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Runny nose: Grade 2 | 23 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Runny nose: Grade 3 | 2 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Runny nose: Grade 4 | 0 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Change in eating habits: Any | 32 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Change in eating habits: Grade 1 | 25 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Change in eating habits: Grade 2 | 6 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Change in eating habits: Grade 3 | 1 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Change in eating habits: Grade 4 | 0 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Diarrhea: Any | 49 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Diarrhea: Grade 1 | 45 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Diarrhea: Grade 2 | 2 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Diarrhea: Grade 3 | 0 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Diarrhea: Grade 4 | 2 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Sleepiness: Any | 32 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Sleepiness: Grade 1 | 29 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Sleepiness: Grade 2 | 3 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Sleepiness: Grade 3 | 0 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Sleepiness: Grade 4 | 0 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Irritability: Any | 63 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Irritability: Grade 1 | 51 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Irritability: Grade 2 | 10 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Irritability: Grade 3 | 2 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Irritability: Grade 4 | 0 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Unusual crying: Any | 29 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Unusual crying: Grade 1 | 23 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Unusual crying: Grade 2 | 5 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Unusual crying: Grade 3 | 1 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Unusual crying: Grade 4 | 0 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Vomiting: Any grade | 26 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Vomiting: Grade 1 | 18 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Vomiting: Grade 2 | 8 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Vomiting Grade 3 | 0 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Vomiting: Grade 4 | 0 Participants |
| Group 2: CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Change in eating habits: Grade 3 | 0 Participants |
| Group 2: CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Fever: Grade 1 | 39 Participants |
| Group 2: CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Sleepiness: Any | 12 Participants |
| Group 2: CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Runny nose: Grade 3 | 1 Participants |
| Group 2: CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Irritability: Grade 4 | 0 Participants |
| Group 2: CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Rash: Grade 1 | 12 Participants |
| Group 2: CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Irritability: Grade 3 | 0 Participants |
| Group 2: CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Sleepiness: Grade 1 | 12 Participants |
| Group 2: CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Cough: Grade 1 | 98 Participants |
| Group 2: CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Irritability: Grade 2 | 4 Participants |
| Group 2: CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Vomiting: Grade 2 | 4 Participants |
| Group 2: CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Vomiting: Grade 1 | 17 Participants |
| Group 2: CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Sleepiness: Grade 2 | 0 Participants |
| Group 2: CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Change in eating habits: Grade 1 | 23 Participants |
| Group 2: CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Fever: Grade 4 | 1 Participants |
| Group 2: CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Runny nose: Any | 143 Participants |
| Group 2: CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Change in eating habits: Grade 4 | 0 Participants |
| Group 2: CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Sleepiness: Grade 3 | 0 Participants |
| Group 2: CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Runny nose: Grade 4 | 0 Participants |
| Group 2: CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Irritability: Grade 1 | 32 Participants |
| Group 2: CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Rash: Any | 13 Participants |
| Group 2: CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Vomiting: Grade 4 | 0 Participants |
| Group 2: CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Sleepiness: Grade 4 | 0 Participants |
| Group 2: CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Fever: Grade 2 | 21 Participants |
| Group 2: CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Irritability: Any | 36 Participants |
| Group 2: CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Rash: Grade 3 | 0 Participants |
| Group 2: CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Runny nose: Grade 2 | 14 Participants |
| Group 2: CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Diarrhea: Any | 29 Participants |
| Group 2: CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Rash: Grade 4 | 0 Participants |
| Group 2: CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Cough: Grade 4 | 0 Participants |
| Group 2: CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Cough: Grade 3 | 2 Participants |
| Group 2: CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Fever: Any | 87 Participants |
| Group 2: CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Diarrhea: Grade 1 | 23 Participants |
| Group 2: CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Unusual crying: Grade 4 | 0 Participants |
| Group 2: CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Cough: Grade 2 | 18 Participants |
| Group 2: CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Change in eating habits: Grade 2 | 4 Participants |
| Group 2: CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Vomiting: Any grade | 21 Participants |
| Group 2: CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Diarrhea: Grade 2 | 5 Participants |
| Group 2: CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Cough: Any | 118 Participants |
| Group 2: CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Unusual crying: Grade 2 | 3 Participants |
| Group 2: CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Rash: Grade 2 | 1 Participants |
| Group 2: CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Unusual crying: Grade 3 | 0 Participants |
| Group 2: CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Diarrhea: Grade 3 | 1 Participants |
| Group 2: CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Runny nose: Grade 1 | 128 Participants |
| Group 2: CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Vomiting Grade 3 | 0 Participants |
| Group 2: CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Unusual crying: Grade 1 | 17 Participants |
| Group 2: CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Unusual crying: Any | 20 Participants |
| Group 2: CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Diarrhea: Grade 4 | 0 Participants |
| Group 2: CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Change in eating habits: Any | 27 Participants |
| Group 2: CD-JEV | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Fever: Grade 3 | 26 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Cough: Grade 2 | 16 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Change in eating habits: Any | 36 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Rash: Grade 4 | 1 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Change in eating habits: Grade 1 | 29 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Change in eating habits: Grade 2 | 6 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Unusual crying: Grade 4 | 0 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Change in eating habits: Grade 3 | 1 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Rash: Grade 3 | 0 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Change in eating habits: Grade 4 | 0 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Fever: Grade 1 | 31 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Diarrhea: Any | 34 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Diarrhea: Grade 1 | 30 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Rash: Grade 2 | 2 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Diarrhea: Grade 2 | 1 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Vomiting: Any grade | 22 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Diarrhea: Grade 3 | 2 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Diarrhea: Grade 4 | 1 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Rash: Grade 1 | 16 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Sleepiness: Any | 15 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Sleepiness: Grade 1 | 15 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Sleepiness: Grade 2 | 0 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Rash: Any | 19 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Vomiting: Grade 1 | 16 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Sleepiness: Grade 3 | 0 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Sleepiness: Grade 4 | 0 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Irritability: Any | 46 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Fever: Grade 4 | 0 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Irritability: Grade 1 | 40 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Irritability: Grade 2 | 4 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Vomiting: Grade 2 | 3 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Irritability: Grade 3 | 2 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Fever: Grade 3 | 25 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Irritability: Grade 4 | 0 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Fever: Any | 79 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Unusual crying: Any | 29 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Vomiting: Grade 4 | 1 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Unusual crying: Grade 1 | 24 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Fever: Grade 2 | 23 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Unusual crying: Grade 2 | 5 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Cough: Grade 3 | 0 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Cough: Grade 4 | 0 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Cough: Grade 1 | 95 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Runny nose: Any | 133 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Vomiting Grade 3 | 2 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Runny nose: Grade 1 | 117 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Runny nose: Grade 2 | 14 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Cough: Any | 111 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Unusual crying: Grade 3 | 0 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Runny nose: Grade 3 | 2 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Runny nose: Grade 4 | 0 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Diarrhea: Grade 4 | 1 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Runny nose: Grade 3 | 0 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Vomiting: Any grade | 31 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Runny nose: Grade 1 | 119 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Unusual crying: Any | 20 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Fever: Grade 2 | 26 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Cough: Any | 103 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Rash: Grade 1 | 16 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Change in eating habits: Grade 2 | 5 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Unusual crying: Grade 1 | 16 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Change in eating habits: Grade 1 | 21 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Diarrhea: Grade 3 | 1 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Diarrhea: Grade 2 | 9 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Rash: Grade 4 | 0 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Cough: Grade 2 | 13 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Diarrhea: Grade 1 | 25 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Change in eating habits: Any | 27 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Rash: Grade 2 | 2 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Runny nose: Grade 2 | 16 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Cough: Grade 3 | 0 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Cough: Grade 1 | 90 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Unusual crying: Grade 2 | 3 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Diarrhea: Any | 36 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Unusual crying: Grade 3 | 1 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Cough: Grade 4 | 0 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Fever: Grade 4 | 1 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Fever: Any | 84 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Sleepiness: Grade 4 | 0 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Fever: Grade 1 | 25 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Irritability: Any | 33 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Change in eating habits: Grade 4 | 0 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Vomiting: Grade 1 | 20 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Sleepiness: Grade 3 | 0 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Unusual crying: Grade 4 | 0 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Irritability: Grade 1 | 30 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Sleepiness: Grade 2 | 1 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Rash: Any | 18 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Sleepiness: Grade 1 | 15 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Vomiting Grade 3 | 1 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Irritability: Grade 2 | 2 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Fever: Grade 3 | 32 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Runny nose: Any | 135 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Vomiting: Grade 4 | 1 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Change in eating habits: Grade 3 | 1 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Irritability: Grade 3 | 1 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Runny nose: Grade 4 | 0 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Vomiting: Grade 2 | 9 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Sleepiness: Any | 16 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Rash: Grade 3 | 0 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity | Irritability: Grade 4 | 0 Participants |
Secondary
Number of Participants With Unsolicited Adverse Events Within 28 Days of Each Vaccination
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
Population: Safety population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: MMR and CD-JEV | Number of Participants With Unsolicited Adverse Events Within 28 Days of Each Vaccination | Any adverse event | 207 Participants |
| Group 1: MMR and CD-JEV | Number of Participants With Unsolicited Adverse Events Within 28 Days of Each Vaccination | Related adverse events | 35 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Unsolicited Adverse Events Within 28 Days of Each Vaccination | Any adverse event | 211 Participants |
| Group 2: MMR Then CD-JEV | Number of Participants With Unsolicited Adverse Events Within 28 Days of Each Vaccination | Related adverse events | 22 Participants |
| Group 2: CD-JEV | Number of Participants With Unsolicited Adverse Events Within 28 Days of Each Vaccination | Any adverse event | 164 Participants |
| Group 2: CD-JEV | Number of Participants With Unsolicited Adverse Events Within 28 Days of Each Vaccination | Related adverse events | 20 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Unsolicited Adverse Events Within 28 Days of Each Vaccination | Related adverse events | 22 Participants |
| Group 1: MMR Dose 2 | Number of Participants With Unsolicited Adverse Events Within 28 Days of Each Vaccination | Any adverse event | 110 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Unsolicited Adverse Events Within 28 Days of Each Vaccination | Any adverse event | 148 Participants |
| Group 2: MMR Dose 2 | Number of Participants With Unsolicited Adverse Events Within 28 Days of Each Vaccination | Related adverse events | 30 Participants |
Secondary
Percentage of Participants With Japanese Encephalitis Seropositivity 28 Days Post-vaccination
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)
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: MMR and CD-JEV | Percentage of Participants With Japanese Encephalitis Seropositivity 28 Days Post-vaccination | 72.3 percentage of participants |
| Group 2: MMR Then CD-JEV | Percentage of Participants With Japanese Encephalitis Seropositivity 28 Days Post-vaccination | 68.2 percentage of participants |
95% CI: [-3.1, 11.3]
Secondary
Percentage of Participants With Mumps Seropositivity 56 Days Post-vaccination
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)
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: MMR and CD-JEV | Percentage of Participants With Mumps Seropositivity 56 Days Post-vaccination | 98.5 percentage of participants |
| Group 2: MMR Then CD-JEV | Percentage of Participants With Mumps Seropositivity 56 Days Post-vaccination | 98.5 percentage of participants |
95% CI: [-2, 2.1]
Secondary
Seroconversion Rate for Measles 56 Days Post-vaccination
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)
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: MMR and CD-JEV | Seroconversion Rate for Measles 56 Days Post-vaccination | 98.1 percentage of participants |
| Group 2: MMR Then CD-JEV | Seroconversion Rate for Measles 56 Days Post-vaccination | 98.0 percentage of participants |
95% CI: [-2.1, 2.2]
Secondary
Seroconversion Rate for Mumps 56 Days Post-vaccination
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)
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: MMR and CD-JEV | Seroconversion Rate for Mumps 56 Days Post-vaccination | 96.7 percentage of participants |
| Group 2: MMR Then CD-JEV | Seroconversion Rate for Mumps 56 Days Post-vaccination | 95.1 percentage of participants |
95% CI: [-1.8, 4.9]
Secondary
Seroconversion Rate for Rubella 56 Days Post-vaccination
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)
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: MMR and CD-JEV | Seroconversion Rate for Rubella 56 Days Post-vaccination | 100.0 percentage of participants |
| Group 2: MMR Then CD-JEV | Seroconversion Rate for Rubella 56 Days Post-vaccination | 99.7 percentage of participants |
95% CI: [-0.3, 1]