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| ID | Type | Description | Link |
|---|---|---|---|
| UTN: U1111-1112-2143 | Other Identifier | WHO |
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This study is designed to compare the immunogenicity of Japanese encephalitis chimeric virus vaccine (JE-CV) and measles-mumps-rubella (MMR)vaccine when given together or when given at separate visits 6 weeks apart in toddlers aged 12 to 18 months.
Primary objective:
Secondary objectives:
All participants will receive Japanese encephalitis chimeric virus vaccine and measles-mumps-rubella vaccine and will be monitored for safety throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Participants will receive the Japanese encephalitis chimeric virus vaccine (JE-CV) on Day 0 and Measles, mumps, and rubella live attenuated virus vaccine (MMR) on Day 42 |
|
| Group 2 | Experimental | Participants will receive Measles, mumps, and rubella live attenuated virus vaccine (MMR) on Day 0, and the Japanese encephalitis chimeric virus vaccine (JE-CV) on Day 42. |
|
| Group 3 | Experimental | Participants will receive the Measles, mumps, and rubella live attenuated virus vaccine (MMR) and the Japanese encephalitis chimeric virus vaccine (JE-CV) on Day 0 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Japanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virus | Biological | 0.5 mL each; Subcutaneous (SC) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Seroconversion to Vaccine Antigens Following Concomitant Administration of Japanese Encephalitis Chimeric Virus Vaccine (JECV) and MMR or Single Administration of JE-CV and MMR Vaccine at 42 Days Following First Vaccination | JE-CV antigens were measured using a 50% plaque reduction neutralization test (PRNT50); MMR antigens were measured using enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as: for JE-CV - participants with a pre-vaccination titer <1/10 and post-vaccination titer ≥1/10, or a pre-vaccination titer ≥1/10 and 4-fold increase from pre- to post; for Measles - post-vaccination titer ≥120 mIU/ml, when pre-vaccination titer is <120 mIU/ml; for Mumps - post-vaccination titer ≥1/10 U/ml when pre-vaccination titer is <10 U/ml; and for Rubella, post-vaccination titer ≥1/10 U/ml when pre-vaccination titer is <10 U/ml. | Day 0 (pre-vaccination) and Day 42 post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Seroconversion to JE-CV and MMR Antigens Before and 42 Days Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | JE-CV antigens were measured using a 50% plaque reduction neutralization test (PRNT50); MMR antigens were measured using enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as: for JE-CV - participants with a pre-vaccination titer <1/10 and post-vaccination titer ≥1/10, or a pre-vaccination titer ≥1/10 and 4-fold increase from pre- to post; for Measles - post-vaccination titer ≥120 mIU/ml, when pre-vaccination titer is <120 mIU/ml; for Mumps - post-vaccination titer ≥1/10 U/ml when pre-vaccination titer is <10 U/ml; and for Rubella, post-vaccination titer ≥1/10 U/ml when pre-vaccination titer is <10 U/m |
| Measure | Description | Time Frame |
|---|---|---|
| Serological Status of Flavivirus at Before (Baseline) Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Neutralizing antibodies levels against dengue were only evaluated on subjects ELISA positive for Immunoglobulin G (IgG) or Immunoglobulin M (IgM). Flavivirus positive was defined as antibodies against JE-CV virus ≥10 (l/dil) or antibodies against at least one dengue virus serotype ≥10 (l/dil); Flavivirus negative was defined as antibodies against JE CV virus < 10 (l/dil) and antibodies against the 4 dengue virus serotypes < 10 (l/dil). |
Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taichung | Taiwan | |||||
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| Label | URL |
|---|---|
| Related Info | View source |
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A total of 550 participants who met all of the inclusion and none of the exclusion criteria were randomized, 542 were vaccinated and reported.
Study participants were enrolled from 14 August 2010 through 28 July 2011 at 5 clinic centers in Taiwan.
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| ID | Title | Description |
|---|---|---|
| FG000 | JE CV + MMR (Group 1) | Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42 |
| FG001 | MMR + JE CV (Group 2) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Japanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virus | Biological | 0.5 mL each, Subcutaneous (SC) |
|
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| Japanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virus | Biological | 0.5 mL each, subcutaneous (SC) |
|
|
| Pre-vaccination and Day 42 post-vaccination |
| Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | JE-CV antigens were measured using a 50% plaque reduction neutralization test (PRNT50); MMR antigens were measured using enzyme linked immunosorbent assay (ELISA). Seroprotection was defined as: for JE-CV - participants with a pre-vaccination titer <1/10 (1/dil) and post-vaccination titer ≥1/10, (1/dil) or a pre-vaccination titer ≥1/10 and 4-fold increase from pre- to post; for Measles - post-vaccination titer ≥120 mIU/ml, when pre-vaccination titer is <120 mIU/ml; for Mumps - post-vaccination titer ≥1/10 units/ml when pre-vaccination titer is <10 units/ml; and for Rubella, post-vaccination titer ≥1/10 IU/ml when pre-vaccination titer is <10 IU/m | Pre-vaccination and up to Month 12 post-vaccination |
| Geometric Mean Titers of Antibodies to Vaccine Antigens Before and After Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | JE-CV antigens were measured using a 50% plaque reduction neutralization test (PRNT50); MMR antigens were measured using enzyme linked immunosorbent assay (ELISA). | Pre-vaccination and Day 42 post-vaccination |
| Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine | Solicited injection site: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability. Grade 3 injection site: Pain - Cries when injected limb is moved or movement of limb is reduced; Erythema and Swelling - ≥5 cm. Grade 3 systemic reactions: Fever - >39.5°C; Vomiting - ≥6 episodes per 24 hours or requiring parenteral hydration; Crying Abnormal - >3 hours; Drowsiness - Sleeping most of the time or difficult to wake; Appetite Lost - Refused ≥3 feeds/meals or refused most feeds/meals; Irritability - Inconsolable. | Day 0 up to Day14 post-vaccination |
| Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine | Solicited injection site: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability. Grade 3 injection site: Pain - Cries when injected limb is moved or movement of limb is reduced; Erythema and Swelling - ≥5 cm. Grade 3 systemic reactions: Fever - >39.5°C; Vomiting - ≥6 episodes per 24 hours or requiring parenteral hydration; Crying Abnormal - >3 hours; Drowsiness - Sleeping most of the time or difficult to wake; Appetite Lost - Refused ≥3 feeds/meals or refused most feeds/meals; Irritability - Inconsolable. | Day 0 up to Day 14 post-vaccination |
| Day 0 (pre-vaccination) |
| Taipei |
| Taiwan |
| Taoyuan | Taiwan |
Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE CV vaccine on day 42 |
| FG002 | JE CV/MMR (Group 3) | Participants 12 to 18 months of age received one dose each of MMR and JE CV vaccine on day 0 |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | JE CV + MMR (Group 1) | Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42 |
| BG001 | MMR + JE CV (Group 2) | Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE CV vaccine on day 42 |
| BG002 | JE CV/MMR (Group 3) | Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0 |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Months |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Seroconversion to Vaccine Antigens Following Concomitant Administration of Japanese Encephalitis Chimeric Virus Vaccine (JECV) and MMR or Single Administration of JE-CV and MMR Vaccine at 42 Days Following First Vaccination | JE-CV antigens were measured using a 50% plaque reduction neutralization test (PRNT50); MMR antigens were measured using enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as: for JE-CV - participants with a pre-vaccination titer <1/10 and post-vaccination titer ≥1/10, or a pre-vaccination titer ≥1/10 and 4-fold increase from pre- to post; for Measles - post-vaccination titer ≥120 mIU/ml, when pre-vaccination titer is <120 mIU/ml; for Mumps - post-vaccination titer ≥1/10 U/ml when pre-vaccination titer is <10 U/ml; and for Rubella, post-vaccination titer ≥1/10 U/ml when pre-vaccination titer is <10 U/ml. | Seroconversion was assessed in the Per Protocol Analysis Set with evaluable data. | Posted | Number | Percentage of Participants | Day 0 (pre-vaccination) and Day 42 post-vaccination |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Seroconversion to JE-CV and MMR Antigens Before and 42 Days Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | JE-CV antigens were measured using a 50% plaque reduction neutralization test (PRNT50); MMR antigens were measured using enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as: for JE-CV - participants with a pre-vaccination titer <1/10 and post-vaccination titer ≥1/10, or a pre-vaccination titer ≥1/10 and 4-fold increase from pre- to post; for Measles - post-vaccination titer ≥120 mIU/ml, when pre-vaccination titer is <120 mIU/ml; for Mumps - post-vaccination titer ≥1/10 U/ml when pre-vaccination titer is <10 U/ml; and for Rubella, post-vaccination titer ≥1/10 U/ml when pre-vaccination titer is <10 U/m | Seroconversion to JE-CV and to MMR vaccine antigen was assessed in all participants who were randomized, vaccinated, who performed all protocol defined activities and has evaluable data (Per-protocol Analysis Set). | Posted | Number | Percentage of Participants | Pre-vaccination and Day 42 post-vaccination |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | JE-CV antigens were measured using a 50% plaque reduction neutralization test (PRNT50); MMR antigens were measured using enzyme linked immunosorbent assay (ELISA). Seroprotection was defined as: for JE-CV - participants with a pre-vaccination titer <1/10 (1/dil) and post-vaccination titer ≥1/10, (1/dil) or a pre-vaccination titer ≥1/10 and 4-fold increase from pre- to post; for Measles - post-vaccination titer ≥120 mIU/ml, when pre-vaccination titer is <120 mIU/ml; for Mumps - post-vaccination titer ≥1/10 units/ml when pre-vaccination titer is <10 units/ml; and for Rubella, post-vaccination titer ≥1/10 IU/ml when pre-vaccination titer is <10 IU/m | Seroprotection to JE-CV and to MMR vaccine antigen was assessed in all participants who were randomized, vaccinated and who performed all protocol defined activities the Full Analysis Set. | Posted | Number | Participants | Pre-vaccination and up to Month 12 post-vaccination |
| ||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Titers of Antibodies to Vaccine Antigens Before and After Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | JE-CV antigens were measured using a 50% plaque reduction neutralization test (PRNT50); MMR antigens were measured using enzyme linked immunosorbent assay (ELISA). | Geometric mean titers were assessed in the Per Protocol Analysis Set population with evaluable data. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Pre-vaccination and Day 42 post-vaccination |
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine | Solicited injection site: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability. Grade 3 injection site: Pain - Cries when injected limb is moved or movement of limb is reduced; Erythema and Swelling - ≥5 cm. Grade 3 systemic reactions: Fever - >39.5°C; Vomiting - ≥6 episodes per 24 hours or requiring parenteral hydration; Crying Abnormal - >3 hours; Drowsiness - Sleeping most of the time or difficult to wake; Appetite Lost - Refused ≥3 feeds/meals or refused most feeds/meals; Irritability - Inconsolable. | Solicited injection site and systemic events were assessed in all randomized and vaccinated participants, the Safety Analysis Set. | Posted | Number | Participants | Day 0 up to Day14 post-vaccination |
| ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Serological Status of Flavivirus at Before (Baseline) Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Neutralizing antibodies levels against dengue were only evaluated on subjects ELISA positive for Immunoglobulin G (IgG) or Immunoglobulin M (IgM). Flavivirus positive was defined as antibodies against JE-CV virus ≥10 (l/dil) or antibodies against at least one dengue virus serotype ≥10 (l/dil); Flavivirus negative was defined as antibodies against JE CV virus < 10 (l/dil) and antibodies against the 4 dengue virus serotypes < 10 (l/dil). | Serological status of Flavivirus infection was assessed in the Full Analysis Set. | Posted | Number | Participants | Day 0 (pre-vaccination) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine | Solicited injection site: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability. Grade 3 injection site: Pain - Cries when injected limb is moved or movement of limb is reduced; Erythema and Swelling - ≥5 cm. Grade 3 systemic reactions: Fever - >39.5°C; Vomiting - ≥6 episodes per 24 hours or requiring parenteral hydration; Crying Abnormal - >3 hours; Drowsiness - Sleeping most of the time or difficult to wake; Appetite Lost - Refused ≥3 feeds/meals or refused most feeds/meals; Irritability - Inconsolable. | Solicited injection site and systemic events were assessed in all randomized and vaccinated participants, the Safety Analysis Set. | Posted | Number | Participants | Day 0 up to Day 14 post-vaccination |
|
Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | JE CV + MMR (Group 1) | Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42 | 10 | 102 | 30 | 102 | ||
| EG001 | MMR + JE CV (Group 2) | Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE CV vaccine on day 42 | 21 | 219 | 80 | 219 | ||
| EG002 | JE CV/MMR (Group 3) | Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0 | 13 | 220 | 79 | 220 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dacryostenosis acquired | Eye disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Croup infectious | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Diarrhea infectious | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Exanthema subitum | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Gastroenteritis norovirus | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Gastroenteritis rotavirus | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Gastroenteritis salmonella | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Hand foot and mouth disease | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Herpangina | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Periorbital cellulitis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Pneumonia pneumococcal | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 12.0 | Non-systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 12.0 | Non-systematic Assessment |
| |
| Febrile convulsion | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Somnolence | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Injection site Pain | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Injection site Erythema | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Injection site Swelling | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Fever | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Crying Abnormal | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Drowsiness | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Appetite Lost | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Sanofi Pasteur Inc. | RegistryContactUs@sanofipasteur.com |
| 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
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Measles (N = 0, 170, 193) |
|
| Mumps (N = 0, 173, 194) |
|
| Rubella (N = 0, 154, 178) |
|
| OG002 | JE-CV/MMR (Group 3) | Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0 |
|
|
| OG002 | JE-CV/MMR (Group 3) | Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0 |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| JE CV/MMR (Group 3) |
Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0 |
|
|
|
|
| JE CV/MMR (Group 3) |
Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0 |
|
|