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

NCT01188343 | Completed Phase 3 Results DMC

• 2 other identifiers: JEC04UTN: U1111-1112-2143
• Study Type: interventional
• Target: 542
• Locations: 1 country
• Sites: 3

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.

Conditions

Japanese Encephalitis; Measles; Mumps; Rubella

Keywords

Japanese Encephalitis; Japanese encephalitis chimeric virus vaccine; Measles; Mumps; Rubella

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• 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

• 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

• 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

• Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine

  Day 0 up to Day14 post-vaccination

• Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine

  Day 0 up to Day 14 post-vaccination

Other Outcomes (1)

• Serological Status of Flavivirus at Before (Baseline) Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine

  Day 0 (pre-vaccination)

Study Arms (3)

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

Biological: Japanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virus

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.

Biological: Japanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virus

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

Biological: Japanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virus

Interventions

Japanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virus BIOLOGICAL

0.5 mL each; Subcutaneous (SC)

Also known as: JE-CV, MMR II®

Group 1

Eligibility Criteria

• Age: 12 Months - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg.
• Subject in good health based on medical history and physical examination.
• Provision of informed consent form signed by at least one parent or other legally acceptable representative, and by an independent witness if the parents or legally acceptable representative cannot read.
• Subject and parent/legally acceptable representative or delegate able to attend all scheduled visits and comply with all trial procedures.

You may not qualify if:

• Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination.
• Planned participation in another clinical trial during the present trial period.
• Receipt of any vaccine in the 4 weeks preceding the first trial vaccination except for pandemic influenza vaccination, which may be received at least two weeks before the study vaccines.
• Planned receipt of any vaccine up to the 6 weeks following the last trial vaccination except for pandemic influenza vaccine. In the event of a local or national immunization program with a pandemic influenza vaccine, participants who receive a pandemic influenza vaccine at any time during the trial will not be withdrawn from the trial.
• Previous vaccination against measles, measles-mumps-rubella (MMR), or flavivirus disease, including Japanese encephalitis (JE).
• Receipt of blood in the past 6 months that might interfere with the assessment of the immune response
• Receipt of intravenous injection of plasma, platelet product, or high dose of intravenous immunoglobulin in the past 11 months
• Receipt of intramuscular treatment of immunoglobulin or Hepatitis B immunoglobulin in the past 3 months
• Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy.
• Known history of human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C seropositivity.
• History of measles, mumps, rubella, or flavivirus infection confirmed either clinically, serologically, or microbiologically.
• Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing any of the same substances .
• Known systemic hypersensitivity to gelatin, eggs, or anaphylactic/anaphylactoid reaction to neomycin.
• Known history of thrombocytopenia.
• Administration of any anti-viral within 2 months preceding first vaccination and up to the 6 weeks following the last trial vaccination.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (3)

Unknown Facility

Taichung, Taiwan

Location

Unknown Facility

Taipei, Taiwan

Location

Unknown Facility

Taoyuan District, Taiwan

Location

Related Links

• Related Info

MeSH Terms

Conditions

Encephalitis, Japanese; Measles; Mumps; Rubella

Condition Hierarchy (Ancestors)

Encephalitis, Arbovirus; Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infections; Infectious Encephalitis; Arbovirus Infections; Vector Borne Diseases; Mosquito-Borne Diseases; Virus Diseases; RNA Virus Infections; Flavivirus Infections; Flaviviridae Infections; Encephalitis; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases; Morbillivirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; Rubulavirus Infections; Parotitis; Parotid Diseases; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Rubivirus Infections; Togaviridae Infections

Results Point of Contact

• Title: Medical Director
• Organization: Sanofi Pasteur Inc.

RegistryContactUs@sanofipasteur.com

Study Officials

• Medical Director

  Sanofi Pasteur Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2010
• First Posted: August 25, 2010
• Study Start: August 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: December 1, 2012
• Last Updated: August 15, 2014
• Results First Posted: August 15, 2014

Record last verified: 2014-07

Locations

TW (3)