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| ID | Type | Description | Link |
|---|---|---|---|
| PHRR160822-001339 | Registry Identifier | Philippine Health Research Registry (PHRR) |
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| Name | Class |
|---|---|
| Research Institute for Tropical Medicine | OTHER_GOV |
| Syneos Health | OTHER |
| DFNet Research Inc. | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 - MMR and CD-JEV | Experimental | Participants receiving one dose of CD-JEV vaccine and one dose of MMR vaccine concurrently at Day 0; Group 1 will also receive a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age). |
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| Group 2 - MMR then CD-JEV | Experimental | Participants receiving one dose of MMR vaccine at Day 0 and one dose of CD-JEV 56 days later. Group 2 will receive a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Live attenuated SA 14-14-2 Japanese Encephalitis vaccine | Biological | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 56 days after MMR dose 1 vaccination (Day 56) |
| 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). | 56 days after MMR dose 1 vaccination (Day 56) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 56 days after MMR dose 1 vaccination (Day 56) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Rosario Capeding, MD | Research Institute for Tropical Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Institute for Tropical Medicine | Manila | Philippines |
The study team agrees that the practice of offering study results to participants in human research is fundamental to the ethical principle of respect for persons. However, the sponsor prefers to report at the aggregate level to maintain participant confidentiality and ensure results are community-based. Thus, the sponsor plans to report results at the aggregate level. The sponsor will produce a poster of the results to be placed at each health center. A community meeting may also be held to communicate the results. Aggregate results will also be posted on www.clinicaltrials.gov.
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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 were enrolled at 2 health centers in the Philippines.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | Group 2: MMR Then CD-JEV |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 18, 2017 | Aug 27, 2020 |
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| Measles, mumps, rubella vaccine | Biological | 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. |
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| 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). | 56 days after MMR dose 1 vaccination (Day 56) |
| 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). | 56 days after MMR dose 1 vaccination (Day 56) |
| 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). | 56 days after MMR dose 1 vaccination (Day 56) |
| 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. | 56 days after MMR dose 1 vaccination (Day 56) |
| 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. | 56 days after MMR dose 1 vaccination (Day 56) |
| 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. | 28 days after CD-JEV vaccination (Day 28 for Group 1 and Day 84 for Group 2) |
| 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. | 28 days after CD-JEV vaccination (Day 28 for Group 1 and Day 84 for Group 2) |
| 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:
| 30 minutes following each study vaccination |
| 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):
Systemic reactions:
| 30 minutes through 14 days following each vaccination |
| 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. | 30 minutes through 14 days following each vaccination |
| 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. | 30 minutes through 14 days following each vaccination |
| 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. | 28 days following each vaccination |
| 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:
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. | Up to 112 days |
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). |
| Received MMR Dose 1 |
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| Received CD-JEV |
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| Received MMR Dose 2 |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Median | Full Range | months |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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). | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | 56 days after MMR dose 1 vaccination (Day 56) |
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| 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). | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | 56 days after MMR dose 1 vaccination (Day 56) |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | 56 days after MMR dose 1 vaccination (Day 56) |
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| 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). | 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. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | 56 days after MMR dose 1 vaccination (Day 56) |
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| 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). | 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. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | 56 days after MMR dose 1 vaccination (Day 56) |
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| 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). | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | 56 days after MMR dose 1 vaccination (Day 56) |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | 56 days after MMR dose 1 vaccination (Day 56) |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | 56 days after MMR dose 1 vaccination (Day 56) |
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| 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. | 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 | Posted | Number | 95% Confidence Interval | percentage of participants | 28 days after CD-JEV vaccination (Day 28 for Group 1 and Day 84 for Group 2) |
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| 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. | 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 | Posted | Geometric Mean | 95% Confidence Interval | titer | 28 days after CD-JEV vaccination (Day 28 for Group 1 and Day 84 for Group 2) |
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| 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:
| The safety population included all participants who received a study vaccine and had at least one safety measure post-vaccination. | Posted | Count of Participants | Participants | 30 minutes following each study vaccination |
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| 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):
Systemic reactions:
| Safety population | Posted | Count of Participants | Participants | 30 minutes through 14 days following each vaccination |
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| 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. | Safety population | Posted | Count of Participants | Participants | 30 minutes through 14 days following each vaccination |
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| 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. | Safety population | Posted | Count of Participants | Participants | 30 minutes through 14 days following each vaccination |
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| 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. | Safety population | Posted | Count of Participants | Participants | 28 days following each vaccination |
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| 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:
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. | Safety population | Posted | Count of Participants | Participants | Up to 112 days |
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Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1: MMR Dose 1 + CD-JEV | Participants in Group 1 received one dose of CD-JEV vaccine and one dose of MMR vaccine concurrently on Day 0. | 0 | 314 | 6 | 314 | 207 | 314 |
| EG001 | Group 2: MMR Dose 1 | Participants in Group 2 received one dose of MMR vaccine at Day 0. | 0 | 314 | 12 | 314 | 211 | 314 |
| EG002 | Group 2: CD-JEV | Participants in Group 2 received one dose of CD-JEV on Day 56. | 0 | 309 | 3 | 309 | 164 | 309 |
| EG003 | Group 1: MMR Dose 2 | Participants in Group 1 received a second dose of MMR vaccine on Day 84. | 0 | 313 | 2 | 313 | 110 | 313 |
| EG004 | Group 2: MMR Dose 2 | Participants in Group 2 received a second dose of MMR vaccine on Day 84. | 0 | 311 | 1 | 311 | 147 | 311 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Amoebiasis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Food intolerance | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
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| Febrile convulsion | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
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| Blepharitis | Eye disorders | MedDRA | Systematic Assessment |
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| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
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| Aphthous ulcer | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Teething | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Allergy to arthropod sting | Immune system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Food allergy | Immune system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Body tinea | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Bullous impetigo | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Carbuncle | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Cellulitis orbital | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Conjunctivitis bacterial | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Conjunctivitis viral | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Dermatitis infected | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Exanthema subitum | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Erythema infectiosum | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Hand-foot-and-mouth disease | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Herpangina | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Ludwig angina | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Parasitic gastroenteritis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Pharyngotonsillitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Roseola | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Tinea cruris | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Tinea versicolour | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Upper respiratory tract infection bacterial | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Varicella | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Viral rash | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Anal injury | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Animal bite | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Burns second degree | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Food intolerance | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Irritability | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Febrile convulsion | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Breath holding | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Allergic cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Miliaria | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jorge Flores, MD | PATH | (202) 822-0033 | jeflores@path.org |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 6, 2017 | Aug 27, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D004672 | Encephalitis, Japanese |
| D008457 | Measles |
| D009107 | Mumps |
| D012409 | Rubella |
| ID | Term |
|---|---|
| D004671 | Encephalitis, Arbovirus |
| D018792 | Encephalitis, Viral |
| D020805 | Central Nervous System Viral Diseases |
| D002494 | Central Nervous System Infections |
| D007239 | Infections |
| D000069544 | Infectious Encephalitis |
| D001102 | Arbovirus Infections |
| D000079426 | Vector Borne Diseases |
| D000096724 | Mosquito-Borne Diseases |
| D014777 | Virus Diseases |
| D012327 | RNA Virus Infections |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D004660 | Encephalitis |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D018185 | Morbillivirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D019351 | Rubulavirus Infections |
| D010309 | Parotitis |
| D010305 | Parotid Diseases |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D018355 | Rubivirus Infections |
| D014036 | Togaviridae Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D022542 | Measles-Mumps-Rubella Vaccine |
| ID | Term |
|---|---|
| D017778 | Vaccines, Combined |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D008458 | Measles Vaccine |
| D014765 | Viral Vaccines |
| D009108 | Mumps Vaccine |
| D012411 | Rubella Vaccine |
Not provided
Not provided
|
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| Participants |
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| Participants |
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Participants in Group 2 received one dose of CD-JEV on Day 56. |
| OG003 | Group 1: MMR Dose 2 | Participants in Group 1 received a second dose of MMR vaccine on Day 84. |
| OG004 | Group 2: MMR Dose 2 | Participants in Group 2 received a second dose of MMR vaccine on Day 84. |
|
|
| OG003 |
| Group 1: MMR Dose 2 |
Participants in Group 1 received a second dose of MMR vaccine on Day 84. |
| OG004 | Group 2: MMR Dose 2 | Participants in Group 2 received a second dose of MMR vaccine on Day 84. |
|
|
| OG002 | Group 2: MMR Dose 1 | Participants in Group 2 received one dose of MMR vaccine injected on the left upper thigh on Day 0. |
| OG003 | Group 2: CD-JEV | Participants in Group 2 received one dose of CD-JEV vaccine injected on the left upper thigh on Day 56. |
| OG004 | Group 1: MMR Dose 2 | Participants in Group 1 received a 2nd dose of MMR vaccine injected on the left upper thigh on Day 84. |
| OG005 | Group 2: MMR Dose 2 | Participants in Group 2 received a 2nd dose of MMR vaccine injected on the left upper thigh on Day 84. |
|
|
| OG002 | Group 2: CD-JEV | Participants in Group 2 received one dose of CD-JEV vaccine on Day 56. |
| OG003 | Group 1: MMR Dose 2 | Participants in Group 1 received a second dose of MMR vaccine on Day 84. |
| OG004 | Group 2: MMR Dose 2 | Participants in Group 2 received a second dose of MMR vaccine on Day 84. |
|
|
| OG003 | Group 1: MMR Dose 2 | Participants in Group 1 received a second dose of MMR vaccine on Day 84. |
| OG004 | Group 2: MMR Dose 2 | Participants in Group 2 received a second dose of MMR vaccine on Day 84. |
|
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