Study of Japanese Encephalitis Chimeric Virus Vaccine Given With Measles-Mumps-Rubella Vaccine in Taiwanese Toddlers

Phase 3

Completed

• Conditions: Rubella; Japanese Encephalitis; Measles; Mumps

• Registration Number: NCT01188343
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

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:

* To demonstrate the non-inferiority of the antibody responses in terms of seroconversion of the concomitant administration of JE-CV and MMR compared to the antibody responses after the single administration of JE-CV and MMR vaccine.

Secondary objectives:

* To describe the immune response to JE CV and MMR before and after one dose of JE CV and MMR vaccine, respectively.

* To describe the safety of a single dose of JE-CV and MMR vaccine (given separately at a 6-week interval and the safety of the concomitant administration of JE-CV and MMR vaccine in all subjects up to 6 months after last vaccination.

Detailed Description

All participants will receive Japanese encephalitis chimeric virus vaccine and measles-mumps-rubella vaccine and will be monitored for safety throughout the study.

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-24
• Study First Submitted QC: 2010-08-24
• Study First Posted: 2010-08-25
• Primary Completion: 2012-07
• Study Completion: 2012-12
• Results First Submitted: 2014-06-25
• Status Verified: 2014-07
• Results First Submitted QC: 2014-07-25
• Last Update Submitted: 2014-07-25
• Results First Posted: 2014-08-15
• Last Update Posted: 2014-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 542

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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	Day 0 (pre-vaccination) and Day 42 post-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.

Secondary Outcome Measures

Name	Time	Method
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	Pre-vaccination and up to Month 12 post-vaccination	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
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	Pre-vaccination and Day 42 post-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/m
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine	Day 0 up to Day 14 post-vaccination	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.
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	Pre-vaccination and Day 42 post-vaccination	JE-CV antigens were measured using a 50% plaque reduction neutralization test (PRNT50); MMR antigens were measured using enzyme linked immunosorbent assay (ELISA).
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine	Day 0 up to Day14 post-vaccination	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.