A Phase 4 interventional study of Live attenuated SA 14-14-2 Japanese Encephalitis vaccine and Measles, mumps, rubella vaccine in Encephalitis, Japanese, Measles and Mumps, sponsored by PATH. Completed at 1 site in Philippines. Open to participants aged 9 Months to 9 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-14.
Sponsored by PATH · Phase 4, Interventional, and Prevention
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.
74 studies on the registry are indexed under Encephalitis, Japanese; 3 are open to participants now.
This study's enrollment of 628 is above the median of 300 across 65 interventional studies indexed under Encephalitis, Japanese.
Browse Encephalitis, Japanese studies →PATH is the lead sponsor of 113 studies on the registry; 7 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 10 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Biological: Live attenuated SA 14-14-2 Japanese Encephalitis vaccine · Biological: Measles, mumps, rubella vaccine
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).
Biological: Live attenuated SA 14-14-2 Japanese Encephalitis vaccine · Biological: Measles, mumps, rubella 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
Also known as: CD-JEV, CD.JEVAX®, RS.JEV®
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.
Also known as: MMR, Priorix®
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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
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
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
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
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
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
Participants were enrolled at 2 health centers in the Philippines.
| Milestone | Group 1: MMR and CD-JEV | Group 2: MMR Then CD-JEV |
|---|---|---|
| Started | 314 | 314 |
| Received mmr dose 1 | 314 | 314 |
| Received cd-jev | 314 | 309 |
| Received mmr dose 2 | 313 | 311 |
| Completed | 313 | 311 |
| Not completed | 1 | 3 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 2 |
| Withdrew: Physician decision | 0 | 1 |
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 | Group 1: MMR and CD-JEV | Group 2: MMR Then CD-JEV |
|---|---|---|
| Percentage of Participants With Measles Seropositivity 56 Days Post-vaccination | 98.1 (95.8 to 99.3) | 98.0 (95.8 to 99.3) |
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).
| percentage of participants | Group 1: MMR and CD-JEV | Group 2: MMR Then CD-JEV |
|---|---|---|
| Percentage of Participants With Rubella Seropositivity 56 Days Post-vaccination | 100.0 (98.7 to 100.0) | 99.7 (98.1 to 100.0) |
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.
| percentage of participants | Group 1: MMR and CD-JEV | Group 2: MMR Then CD-JEV |
|---|---|---|
| Percentage of Participants With Mumps Seropositivity 56 Days Post-vaccination | 98.5 (96.3 to 99.6) | 98.5 (96.2 to 99.6) |
Anti-measles neutralizing antibody concentration was measured by the plaque reduction neutralization test (PRNT).
| mIU/mL | Group 1: MMR and CD-JEV | Group 2: MMR Then CD-JEV |
|---|---|---|
| Geometric Mean Concentration (GMC) for Anti-measles Neutralizing Antibody Concentration at 56 Days Post-vaccination | 1964.4 (1769.3 to 2181.0) | 1866.3 (1649.1 to 2112.0) |
Anti-rubella immunoglobulin G (IgG) concentration was measured using a commercial IgG enzyme-linked immunosorbent assay (ELISA).
| IU/mL | Group 1: MMR and CD-JEV | Group 2: MMR Then CD-JEV |
|---|---|---|
| GMC for Anti-rubella IgG Antibody Concentration at 56 Days Post-vaccination | 230.8 (214.4 to 248.5) | 229.8 (210.0 to 251.3) |
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).
| percentage of participants | Group 1: MMR and CD-JEV | Group 2: MMR Then CD-JEV |
|---|---|---|
| Seroconversion Rate for Measles 56 Days Post-vaccination | 98.1 (95.8 to 99.3) | 98.0 (95.8 to 99.3) |
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.
| percentage of participants | Group 1: MMR and CD-JEV | Group 2: MMR Then CD-JEV |
|---|---|---|
| Seroconversion Rate for Mumps 56 Days Post-vaccination | 96.7 (93.8 to 98.5) | 95.1 (91.8 to 97.4) |
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 | Group 1: MMR and CD-JEV | Group 2: MMR Then CD-JEV |
|---|---|---|
| Seroconversion Rate for Rubella 56 Days Post-vaccination | 100.0 (98.7 to 100.0) | 99.7 (98.1 to 100.0) |
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.
| percentage of participants | Group 1: MMR and CD-JEV | Group 2: MMR Then CD-JEV |
|---|---|---|
| Percentage of Participants With Japanese Encephalitis Seropositivity 28 Days Post-vaccination | 72.3 (67.0 to 77.2) | 68.2 (62.6 to 73.4) |
Anti-JE serum neutralizing antibody titer was measured using JE PRNT-50.
| titer | Group 1 - MMR and CD-JEV | Group 2 - MMR Then CD-JEV |
|---|---|---|
| Geometric Mean Titer (GMT) for Serum Neutralizing Antibody Titer to JE Virus at 28 Days Post-vaccination | 24.0 (20.8 to 27.6) | 20.3 (17.8 to 23.1) |
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.
| Participants | Group 1: MMR Dose 1 + CD-JEV | Group 2: MMR Dose 1 | Group 2: CD-JEV | Group 1: MMR Dose 2 | Group 2: MMR Dose 2 |
|---|---|---|---|---|---|
| Any immediate reaction | 6 | 3 | 5 | 5 | 3 |
| MMR local reaction | 3 | 2 | — | 3 | 1 |
| CD-JEV local reaction | 3 | — | 4 | — | — |
| Systemic | 1 | 1 | 1 | 1 | 2 |
| Serious reactions | 0 | 0 | 0 | 0 | 0 |
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
| Participants | Group 1: MMR Dose 1 + CD-JEV | Group 2: MMR Dose 1 | Group 2: CD-JEV | Group 1: MMR Dose 2 | Group 2: MMR Dose 2 |
|---|---|---|---|---|---|
| Any local reactions at MMR injection site | 35 | 31 | — | 12 | 9 |
| Any local reactions at CD-JEV injection site | 34 | — | 13 | — | — |
| Any systemic reactions | 224 | 222 | 190 | 168 | 174 |
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.
| Participants | Group 1: MMR Dose 1 | Group 1: CD-JEV | Group 2: MMR Dose 1 | Group 2: CD-JEV | Group 1: MMR Dose 2 | Group 2: MMR Dose 2 |
|---|---|---|---|---|---|---|
| Ecchymosis: Any | 6 | 6 | 10 | 3 | 0 | 5 |
| Ecchymosis: Grade 1 | 6 | 6 | 10 | 3 | 0 | 5 |
| Ecchymosis: Grade 2 | 0 | 0 | 0 | 0 | 0 | 0 |
| Ecchymosis: Grade 3 | 0 | 0 | 0 | 0 | 0 | 0 |
| Ecchymosis: Grade 4 | 0 | 0 | 0 | 0 | 0 | 0 |
| Erythema: Any | 15 | 13 | 14 | 8 | 5 | 7 |
| Erythema: Grade 1 | 15 | 12 | 14 | 8 | 5 | 7 |
| Erythema: Grade 2 | 0 | 1 | 0 | 0 | 0 | 0 |
| Erythema: Grade 3 | 0 | 0 | 0 | 0 | 0 | 0 |
| Erythema: Grade 4 | 0 | 0 | 0 | 0 | 0 | 0 |
| Edema: Any | 6 | 3 | 7 | 5 | 0 | 4 |
| Edema: Grade 1 | 5 | 3 | 7 | 5 | 0 | 4 |
| Edema: Grade 2 | 1 | 0 | 0 | 0 | 0 | 0 |
| Edema: Grade 3 | 0 | 0 | 0 | 0 | 0 | 0 |
| Edema: Grade 4 | 0 | 0 | 0 | 0 | 0 | 0 |
| Induration: Any | 4 | 7 | 7 | 4 | 0 | 3 |
| Induration: Grade 1 | 4 | 6 | 7 | 4 | 0 | 3 |
| Induration: Grade 2 | 0 | 1 | 0 | 0 | 0 | 0 |
| Induration: Grade 3 | 0 | 0 | 0 | 0 | 0 | 0 |
| Induration: Grade 4 | 0 | 0 | 0 | 0 | 0 | 0 |
| Pain/Tenderness: Any | 18 | 18 | 19 | 6 | 8 | 5 |
| Pain/Tenderness: Grade 1 | 17 | 17 | 17 | 5 | 8 | 4 |
| Pain/Tenderness: Grade 2 | 1 | 1 | 2 | 1 | 0 | 1 |
| Pain/Tenderness: Grade 3 | 0 | 0 | 0 | 0 | 0 | 0 |
| Pain/Tenderness: Grade 4 | 0 | 0 | 0 | 0 | 0 | 0 |
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.
| Participants | Group 1: MMR Dose 1 + CD-JEV | Group 2: MMR Dose 1 | Group 2: CD-JEV | Group 1: MMR Dose 2 | Group 2: MMR Dose 2 |
|---|---|---|---|---|---|
| Fever: Any | 135 | 119 | 87 | 79 | 84 |
| Fever: Grade 1 | 52 | 35 | 39 | 31 | 25 |
| Fever: Grade 2 | 38 | 43 | 21 | 23 | 26 |
| Fever: Grade 3 | 44 | 40 | 26 | 25 | 32 |
| Fever: Grade 4 | 1 | 1 | 1 | 0 | 1 |
| Rash: Any | 27 | 33 | 13 | 19 | 18 |
| Rash: Grade 1 | 23 | 28 | 12 | 16 | 16 |
| Rash: Grade 2 | 3 | 4 | 1 | 2 | 2 |
| Rash: Grade 3 | 0 | 1 | 0 | 0 | 0 |
| Rash: Grade 4 | 1 | 0 | 0 | 1 | 0 |
| Cough: Any | 127 | 116 | 118 | 111 | 103 |
| Cough: Grade 1 | 103 | 92 | 98 | 95 | 90 |
| Cough: Grade 2 | 20 | 22 | 18 | 16 | 13 |
| Cough: Grade 3 | 4 | 2 | 2 | 0 | 0 |
| Cough: Grade 4 | 0 | 0 | 0 | 0 | 0 |
| Runny nose: Any | 167 | 163 | 143 | 133 | 135 |
| Runny nose: Grade 1 | 139 | 138 | 128 | 117 | 119 |
| Runny nose: Grade 2 | 26 | 23 | 14 | 14 | 16 |
| Runny nose: Grade 3 | 2 | 2 | 1 | 2 | 0 |
| Runny nose: Grade 4 | 0 | 0 | 0 | 0 | 0 |
| Change in eating habits: Any | 49 | 32 | 27 | 36 | 27 |
| Change in eating habits: Grade 1 | 40 | 25 | 23 | 29 | 21 |
| Change in eating habits: Grade 2 | 9 | 6 | 4 | 6 | 5 |
| Change in eating habits: Grade 3 | 0 | 1 | 0 | 1 | 1 |
| Change in eating habits: Grade 4 | 0 | 0 | 0 | 0 | 0 |
| Diarrhea: Any | 58 | 49 | 29 | 34 | 36 |
| Diarrhea: Grade 1 | 49 | 45 | 23 | 30 | 25 |
| Diarrhea: Grade 2 | 7 | 2 | 5 | 1 | 9 |
| Diarrhea: Grade 3 | 1 | 0 | 1 | 2 | 1 |
| Diarrhea: Grade 4 | 1 | 2 | 0 | 1 | 1 |
| Sleepiness: Any | 43 | 32 | 12 | 15 | 16 |
| Sleepiness: Grade 1 | 39 | 29 | 12 | 15 | 15 |
| Sleepiness: Grade 2 | 4 | 3 | 0 | 0 | 1 |
| Sleepiness: Grade 3 | 0 | 0 | 0 | 0 | 0 |
| Sleepiness: Grade 4 | 0 | 0 | 0 | 0 | 0 |
| Irritability: Any | 80 | 63 | 36 | 46 | 33 |
| Irritability: Grade 1 | 63 | 51 | 32 | 40 | 30 |
| Irritability: Grade 2 | 14 | 10 | 4 | 4 | 2 |
| Irritability: Grade 3 | 3 | 2 | 0 | 2 | 1 |
| Irritability: Grade 4 | 0 | 0 | 0 | 0 | 0 |
| Unusual crying: Any | 54 | 29 | 20 | 29 | 20 |
| Unusual crying: Grade 1 | 45 | 23 | 17 | 24 | 16 |
| Unusual crying: Grade 2 | 8 | 5 | 3 | 5 | 3 |
| Unusual crying: Grade 3 | 1 | 1 | 0 | 0 | 1 |
| Unusual crying: Grade 4 | 0 | 0 | 0 | 0 | 0 |
| Vomiting: Any grade | 29 | 26 | 21 | 22 | 31 |
| Vomiting: Grade 1 | 25 | 18 | 17 | 16 | 20 |
| Vomiting: Grade 2 | 4 | 8 | 4 | 3 | 9 |
| Vomiting Grade 3 | 0 | 0 | 0 | 2 | 1 |
| Vomiting: Grade 4 | 0 | 0 | 0 | 1 | 1 |
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.
| Participants | Group 1: MMR Dose 1 + CD-JEV | Group 2: MMR Dose 1 | Group 2: CD-JEV | Group 1: MMR Dose 2 | Group 2: MMR Dose 2 |
|---|---|---|---|---|---|
| Any adverse event | 207 | 211 | 164 | 110 | 148 |
| Related adverse events | 35 | 22 | 20 | 22 | 30 |
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.
| Participants | Group 1: MMR and CD-JEV | Group 2: MMR Then CD-JEV |
|---|---|---|
| Any serious adverse event | 8 | 15 |
| Related serious adverse event | 0 | 0 |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1: MMR Dose 1 + CD-JEV | 0/314 (0%) | 6/314 (1.9%) | 207/314 (65.9%) |
| Group 2: MMR Dose 1 | 0/314 (0%) | 12/314 (3.8%) | 211/314 (67.2%) |
| Group 2: CD-JEV | 0/309 (0%) | 3/309 (1%) | 164/309 (53.1%) |
| Group 1: MMR Dose 2 | 0/313 (0%) | 2/313 (0.6%) | 110/313 (35.1%) |
| Group 2: MMR Dose 2 | 0/311 (0%) | 1/311 (0.3%) | 147/311 (47.3%) |
| Event | Group 1: MMR Dose 1 + CD-JEV | Group 2: MMR Dose 1 | Group 2: CD-JEV | Group 1: MMR Dose 2 | Group 2: MMR Dose 2 |
|---|---|---|---|---|---|
| GastroenteritisInfections and infestations | 5/314 | 3/314 | 1/309 | 2/313 | 0/311 |
| AmoebiasisInfections and infestations | 0/314 | 3/314 | 0/309 | 0/313 | 0/311 |
| PneumoniaInfections and infestations | 0/314 | 3/314 | 2/309 | 0/313 | 1/311 |
| BronchitisInfections and infestations | 0/314 | 1/314 | 0/309 | 0/313 | 0/311 |
| Urinary tract infectionInfections and infestations | 0/314 | 1/314 | 0/309 | 0/313 | 0/311 |
| Food intoleranceMetabolism and nutrition disorders | 0/314 | 1/314 | 0/309 | 0/313 | 0/311 |
| Febrile convulsionNervous system disorders | 1/314 | 0/314 | 0/309 | 0/313 | 0/311 |
| Event | Group 1: MMR Dose 1 + CD-JEV | Group 2: MMR Dose 1 | Group 2: CD-JEV | Group 1: MMR Dose 2 | Group 2: MMR Dose 2 |
|---|---|---|---|---|---|
| Upper respiratory tract infectionInfections and infestations | 76/314 | 77/314 | 54/309 | 40/313 | 62/311 |
| RhinitisInfections and infestations | 31/314 | 39/314 | 34/309 | 17/313 | 21/311 |
| GastroenteritisInfections and infestations | 31/314 | 22/314 | 19/309 | 10/313 | 24/311 |
| BronchitisInfections and infestations | 16/314 | 24/314 | 20/309 | 13/313 | 15/311 |
| Viral infectionInfections and infestations | 24/314 | 21/314 | 12/309 | 8/313 | 6/311 |
| NasopharyngitisInfections and infestations | 21/314 | 19/314 | 16/309 | 5/313 | 13/311 |
| PneumoniaInfections and infestations | 11/314 | 9/314 | 6/309 | 9/313 | 5/311 |
| Viral upper respiratory tract infectionInfections and infestations | 8/314 | 9/314 | 1/309 | 0/313 | 0/311 |
| Hand-foot-and-mouth diseaseInfections and infestations | 2/314 | 6/314 | 8/309 | 5/313 | 1/311 |
| PyrexiaGeneral disorders | 4/314 | 2/314 | 5/309 | 8/313 | 5/311 |
| Age, Continuous(months) | Group 1: MMR and CD-JEV | Group 2: MMR Then CD-JEV | Total |
|---|---|---|---|
| Median | 9.2 (9.0 to 10.0) | 9.2 (9.0 to 10.0) | 9.2 (9.0 to 10.0) |
| Sex: Female, Male(Participants) | Group 1: MMR and CD-JEV | Group 2: MMR Then CD-JEV | Total |
|---|---|---|---|
| Female | 144 | 157 | 301 |
| Male | 170 | 157 | 327 |
| Race and Ethnicity Not Collected(Participants) | Group 1: MMR and CD-JEV | Group 2: MMR Then CD-JEV | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Group 1: MMR and CD-JEV | Group 2: MMR Then CD-JEV | Total |
|---|---|---|---|
| Philippines | 314 | 314 | 628 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — 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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Studies of the drug tested here: Measles-Mumps-Rubella Vaccine