A Phase 3 interventional study of Japanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virus and Japanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virus in Japanese Encephalitis, Measles and Mumps, sponsored by Sanofi Pasteur, a Sanofi Company. Completed at 3 sites in Taiwan. Open to participants aged 12 Months to 18 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-08-15.
Sponsored by Sanofi Pasteur, a Sanofi Company (part of Sanofi) · Phase 3, Interventional, and Prevention
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.
74 studies on the registry are indexed under Encephalitis, Japanese; 3 are open to participants now.
This study's enrollment of 542 is above the median of 300 across 65 interventional studies indexed under Encephalitis, Japanese.
Browse Encephalitis, Japanese studies →Sanofi Pasteur, a Sanofi Company is the lead sponsor of 374 studies on the registry; 4 are open to participants now.
Of its 94 completed or terminated interventional studies of FDA-regulated products, 73 (78%) have results posted.
First submitted after Sanofi Pasteur became part of Sanofi.
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.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
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.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
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.
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.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
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.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
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.
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
Biological: Japanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virus
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.
Biological: Japanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virus
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
Biological: Japanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virus
0.5 mL each; Subcutaneous (SC)
Also known as: JE-CV, MMR II®
0.5 mL each, Subcutaneous (SC)
Also known as: JE-CV, MMR II®
0.5 mL each, subcutaneous (SC)
Also known as: JE-CV, MMR II®
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.
Time frame: Day 0 (pre-vaccination) and Day 42 post-vaccination
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
Time frame: 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
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Day 0 up to Day 14 post-vaccination
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).
Time frame: Day 0 (pre-vaccination)
Study participants were enrolled from 14 August 2010 through 28 July 2011 at 5 clinic centers in Taiwan.
| Milestone | JE CV + MMR (Group 1) | MMR + JE CV (Group 2) | JE CV/MMR (Group 3) |
|---|---|---|---|
| Started | 102 | 219 | 221 |
| Completed | 101 | 193 | 220 |
| Not completed | 1 | 26 | 1 |
| Withdrew: Not vaccinated | 0 | 2 | 1 |
| Withdrew: Withdrawal by subject | 1 | 24 | 0 |
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.
| Percentage of Participants | JE-CV + MMR (Group 1) | MMR + JE-CV (Group 2) | JE-CV/MMR (Group 3) |
|---|---|---|---|
| JE-CV (N = 95, 0, 194) | 97.9 | NA (0 to 0) | 96.9 (0 to 0) |
| Measles (N = 0, 170, 193) | NA | 97.6 (0 to 0) | 100 (0 to 0) |
| Mumps (N = 0, 173, 194) | NA | 98.8 (0 to 0) | 99.5 (0 to 0) |
| Rubella (N = 0, 154, 178) | NA | 99.4 (0 to 0) | 99.4 (0 to 0) |
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
| Percentage of Participants | JE-CV + MMR (Group 1) | MMR + JE-CV (Group 2) | JE-CV/MMR (Group 3) |
|---|---|---|---|
| JE-CV Pre-vaccination (N = 95, 158, 194) | 0.0 | 0.0 (0 to 0) | 0.0 (0 to 0) |
| JE-CV Post-vaccination (N = 95, 158, 194) | 97.9 | 100.0 (0 to 0) | 96.9 (0 to 0) |
| Measles Pre-vaccination (N = 94, 176, 196) | 4.3 | 2.8 (0 to 0) | 1.0 (0 to 0) |
| Measles Post-vaccination (N = 94, 176, 197) | 97.9 | 97.7 (0 to 0) | 100.0 (0 to 0) |
| Mumps Pre-vaccination (N = 94, 176, 196) | 1.1 | 1.1 (0 to 0) | 0.5 (0 to 0) |
| Mumps Post-vaccination (N = 94, 176, 197) | 100.0 | 98.9 (0 to 0) | 99.5 (0 to 0) |
| Rubella Pre-vaccination (N = 94, 176, 196) | 9.6 | 11.9 (0 to 0) | 8.7 (0 to 0) |
| Rubella Post-vaccination (N = 94, 176, 197) | 100.0 | 99.4 (0 to 0) | 99.5 (0 to 0) |
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
| Participants | JE-CV + MMR (Group 1) | MMR + JE-CV (Group 2) | JE-CV/MMR (Group 3) |
|---|---|---|---|
| JE-CV Pre-vaccination (N=102, 197, 221) | 2 | 10 | 4 |
| JE-CV 6 months Post-vaccination (N=96, 191, 217) | 92 | 190 | 203 |
| JE-CV 12 months Post-vaccination (N=89, 164, 193) | 86 | 162 | 171 |
| Measles Pre-vaccination (N = 101, 217, 219) | 4 | 8 | 2 |
| Measles 6 months Post-vaccination (N=96, 191, 217) | 93 | 189 | 216 |
| Measles 12 months Post-vaccination (N=89, 164, 193 | 87 | 163 | 192 |
| Mumps Pre-vaccination (N=101, 217, 219) | 1 | 2 | 2 |
| Mumps 6 months Post-vaccination (N=96, 191, 217) | 90 | 180 | 208 |
| Mumps 12 months Post-vaccination (N=89, 164, 193) | 82 | 153 | 176 |
| Rubella Pre-vaccination (N=101, 217, 219) | 10 | 23 | 19 |
| Rubella 6 months Post-vaccination (N=96, 191, 217) | 95 | 191 | 217 |
| Rubella 12 months Post-vaccination (N=89, 164, 193 | 89 | 164 | 192 |
JE-CV antigens were measured using a 50% plaque reduction neutralization test (PRNT50); MMR antigens were measured using enzyme linked immunosorbent assay (ELISA).
| Titers | JE CV + MMR (Group 1) | MMR + JE CV (Group 2) | JE CV/MMR (Group 3) |
|---|---|---|---|
| JE-CV pre-vaccination (N = 95, 158, 194) | 5.00 (5.00 to 5.00) | 5.00 (5.00 to 5.00) | 5.00 (5.00 to 5.00) |
| JE-CV post-vaccination (N = 95, 158, 194) | 510 (356 to 731) | 581 (449 to 752) | 332 (258 to 426) |
| Measles pre-vaccination (N = 94, 176, 196) | 34.3 (31.5 to 37.3) | 33.4 (31.4 to 35.5) | 33.4 (32.0 to 35.0) |
| Measles post-vaccination (N = 94, 176, 197) | 1835 (1536 to 2193) | 1723 (1506 to 1971) | 1924 (1753 to 2111) |
| Mumps pre-vaccination (N = 94, 176, 196) | 2.59 (2.46 to 2.71) | 2.63 (2.52 to 2.75) | 2.55 (2.49 to 2.62) |
| Mumps Post-vaccination (N = 94, 176, 197) | 81.1 (70.1 to 93.9) | 87.5 (77.6 to 98.8) | 89.2 (80.0 to 99.5) |
| Rubella pre-vaccination (N = 94, 176, 196) | 3.90 (3.44 to 4.43) | 3.97 (3.60 to 4.37) | 3.60 (3.32 to 3.90) |
| Rubella post-vaccination (N = 94, 176, 197) | 78.0 (68.3 to 89.2) | 81.4 (73.7 to 89.9) | 69.6 (63.6 to 76.0) |
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.
| Participants | JE CV + MMR (Group 1) | MMR + JE CV (Group 2) | JE CV/MMR (Group 3) |
|---|---|---|---|
| Injection site Pain (N = 102, 195, 219) | 18 | 30 (0 to 0) | 35 (0 to 0) |
| Grade 3 Pain (N = 102, 195, 219) | 0 | 0 (0 to 0) | 0 (0 to 0) |
| Injection site Erythema (N = 102, 195, 219) | 11 | 21 (0 to 0) | 24 (0 to 0) |
| Grade 3 Erythema (N = 102, 195, 219) | 0 | 0 (0 to 0) | 0 (0 to 0) |
| Injection site Swelling (N = 102, 195, 219) | 2 | 11 (0 to 0) | 3 (0 to 0) |
| Grade 3 Swelling (N = 102, 195, 219) | 0 | 0 (0 to 0) | 0 (0 to 0) |
| Solicited Fever (N = 102, 195, 219) | 17 | 35 (0 to 0) | 53 (0 to 0) |
| Grade 3 Fever (N = 102, 195, 219) | 1 | 1 (0 to 0) | 1 (0 to 0) |
| Solicited Vomiting (N = 102, 195, 219) | 15 | 21 (0 to 0) | 39 (0 to 0) |
| Grade 3 Vomiting (N = 102, 195, 219) | 0 | 3 (0 to 0) | 0 (0 to 0) |
| Solicited Crying Abnormal (N = 102, 195, 219) | 24 | 56 (0 to 0) | 79 (0 to 0) |
| Grade 3 Crying Abnormal (N = 102, 195, 219) | 2 | 4 (0 to 0) | 5 (0 to 0) |
| Solicited Drowsiness (N = 102, 195, 219) | 26 | 45 (0 to 0) | 67 (0 to 0) |
| Grade 3 Drowsiness (N = 102, 195, 219) | 0 | 3 (0 to 0) | 2 (0 to 0) |
| Solicited Appetite Lost (N = 102, 195, 219) | 25 | 46 (0 to 0) | 78 (0 to 0) |
| Grade 3 Appetite Lost (N = 102, 195, 219) | 3 | 5 (0 to 0) | 6 (0 to 0) |
| Solicited Irritability (N = 102, 195, 219) | 28 | 39 (0 to 0) | 72 (0 to 0) |
| Grade 3 Irritability (N = 102, 195, 219) | 4 | 0 (0 to 0) | 2 (0 to 0) |
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).
| Participants | JE CV + MMR (Group 1) | MMR + JE CV (Group 2) | JE CV/MMR (Group 3) |
|---|---|---|---|
| JE-CV virus/dengue serotypes FV Positive | 2 | 18 (0 to 0) | 5 (0 to 0) |
| JE CV virus/dengue serotypes FV Negative | 100 | 179 (0 to 0) | 216 (0 to 0) |
| JE CV virus | 2 | 10 (0 to 0) | 4 (0 to 0) |
| Any dengue serotype | 0 | 8 (0 to 0) | 1 (0 to 0) |
| Dengue serotype 1 | 0 | 7 (0 to 0) | 1 (0 to 0) |
| Dengue serotype 2 | 0 | 0 (0 to 0) | 0 (0 to 0) |
| Dengue serotype 3 | 0 | 0 (0 to 0) | 0 (0 to 0) |
| Dengue serotype 4 | 0 | 3 (0 to 0) | 0 (0 to 0) |
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.
| Participants | JE CV + MMR (Group 1) | MMR + JE CV (Group 2) | JE CV/MMR (Group 3) |
|---|---|---|---|
| Injection site Pain (N = 101, 211, 219) | 16 | 32 (0 to 0) | 36 (0 to 0) |
| Grade 3 Pain (N = 101, 211, 219) | 0 | 0 (0 to 0) | 0 (0 to 0) |
| Injection site Erythema (N = 101, 211, 219) | 7 | 22 (0 to 0) | 22 (0 to 0) |
| Grade 3 Erythema (N = 101, 211, 219) | 0 | 0 (0 to 0) | 0 (0 to 0) |
| Injection site Swelling (N = 101, 211, 219) | 3 | 7 (0 to 0) | 4 (0 to 0) |
| Grade 3 Swelling (N = 101, 211, 219) | 0 | 0 (0 to 0) | 0 (0 to 0) |
| Solicited Fever (N = 101, 211, 219) | 21 | 48 (0 to 0) | 53 (0 to 0) |
| Grade 3 Fever (N = 101, 211, 219) | 1 | 4 (0 to 0) | 1 (0 to 0) |
| Solicited Vomiting (N = 101, 210, 219) | 12 | 32 (0 to 0) | 39 (0 to 0) |
| Grade 3 Vomiting (N = 101, 210, 219) | 0 | 2 (0 to 0) | 0 (0 to 0) |
| Solicited Crying Abnormal (N = 101, 210, 219) | 30 | 73 (0 to 0) | 79 (0 to 0) |
| Grade 3 Crying Abnormal (N = 101, 210, 219) | 4 | 7 (0 to 0) | 5 (0 to 0) |
| Solicited Drowsiness (N = 101, 210, 219) | 26 | 68 (0 to 0) | 67 (0 to 0) |
| Grade 3 Drowsiness (N = 101, 210, 219) | 1 | 4 (0 to 0) | 2 (0 to 0) |
| Solicited Appetite Lost (N = 101, 210, 219) | 29 | 80 (0 to 0) | 78 (0 to 0) |
| Grade 3 Appetite Lost (N = 101, 210, 219) | 0 | 10 (0 to 0) | 6 (0 to 0) |
| Solicited Irritability (N = 101, 210, 219) | 26 | 64 (0 to 0) | 72 (0 to 0) |
| Grade 3 Irritability (N = 101, 210, 219) | 4 | 3 (0 to 0) | 2 (0 to 0) |
Collected over Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.. Non-serious events are listed at a 5.00% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| JE CV + MMR (Group 1) | — | 10/102 (9.8%) | 30/102 (29.4%) |
| MMR + JE CV (Group 2) | — | 21/219 (9.6%) | 80/219 (36.5%) |
| JE CV/MMR (Group 3) | — | 13/220 (5.9%) | 79/220 (35.9%) |
| Event | JE CV + MMR (Group 1) | MMR + JE CV (Group 2) | JE CV/MMR (Group 3) |
|---|---|---|---|
| HerpanginaInfections and infestations | 1/102 | 5/219 | 2/220 |
| GastroenteritisInfections and infestations | 2/102 | 3/219 | 1/220 |
| PneumoniaInfections and infestations | 2/102 | 2/219 | 2/220 |
| BronchiolitisInfections and infestations | 1/102 | 3/219 | 0/220 |
| BronchopneumoniaInfections and infestations | 1/102 | 2/219 | 3/220 |
| Diarrhea infectiousInfections and infestations | 1/102 | 0/219 | 0/220 |
| Exanthema subitumInfections and infestations | 1/102 | 0/219 | 0/220 |
| Gastroenteritis rotavirusInfections and infestations | 1/102 | 0/219 | 0/220 |
| Pneumonia pneumococcalInfections and infestations | 1/102 | 0/219 | 0/220 |
| Thermal burnInjury, poisoning and procedural complications | 1/102 | 0/219 | 0/220 |
| Event | JE CV + MMR (Group 1) | MMR + JE CV (Group 2) | JE CV/MMR (Group 3) |
|---|---|---|---|
| Appetite LostMetabolism and nutrition disorders | 29/101 | 80/210 | 78/220 |
| Crying AbnormalPsychiatric disorders | 30/101 | 73/210 | 79/220 |
| IrritabilityPsychiatric disorders | 26/101 | 64/210 | 72/220 |
| DrowsinessNervous system disorders | 26/101 | 68/210 | 67/220 |
| SomnolenceNervous system disorders | 26/102 | 45/196 | 67/220 |
| FeverGeneral disorders | 21/101 | 48/211 | 53/220 |
| VomitingGastrointestinal disorders | 12/101 | 32/210 | 39/220 |
| Injection site PainGeneral disorders | 18/102 | 30/195 | 35/220 |
| Injection site ErythemaGeneral disorders | 11/102 | 21/195 | 24/220 |
| Injection site SwellingGeneral disorders | 2/102 | 11/195 | 3/220 |
| Age, Categorical(Participants) | JE CV + MMR (Group 1) | MMR + JE CV (Group 2) | JE CV/MMR (Group 3) | Total |
|---|---|---|---|---|
| <=18 years | 102 | 219 | 221 | 542 |
| Between 18 and 65 years | 0 | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 | 0 |
| Age, Continuous(Months) | JE CV + MMR (Group 1) | MMR + JE CV (Group 2) | JE CV/MMR (Group 3) | Total |
|---|---|---|---|---|
| Mean | 13.1 ± 1.12 | 13.0 ± 1.08 | 13.1 ± 1.19 | 13.1 ± 1.13 |
| Sex: Female, Male(Participants) | JE CV + MMR (Group 1) | MMR + JE CV (Group 2) | JE CV/MMR (Group 3) | Total |
|---|---|---|---|---|
| Female | 46 | 110 | 109 | 265 |
| Male | 56 | 109 | 112 | 277 |
| Region of Enrollment(Participants) | JE CV + MMR (Group 1) | MMR + JE CV (Group 2) | JE CV/MMR (Group 3) | Total |
|---|---|---|---|---|
| Taiwan | 102 | 219 | 221 | 542 |
The record gives a start of Aug 2010, a primary completion of Jul 2012 and a completion of Dec 2012. It does not say whether these dates are actual or estimated.
Results were first posted in Aug 2014, 2 years 1 month after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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Sanofi Pasteur, a Sanofi Company →