Study of a Booster Dose of IMOJEV® One Year After Primary Immunization in Healthy Children in South Korea

NCT01900444 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: JEC22U1111-1127-7153
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 8

Brief Summary

The aim of this study was to document the immunogenicity and safety of a booster dose of IMOJEV administered at least 12 months after the primary dose. Primary objective:

• To describe the immune response to Japanese Encephalitis (JE) before and 28 days after a booster dose of IMOJEV administered at least 12 months after primary vaccination with IMOJEV. Exploratory objectives:
• To describe the safety profile of a booster dose of IMOJEV® .

Conditions

Japanese Encephalitis

Keywords

Japanese encephalitis; Japanese encephalitis chimeric virus vaccine; IMOJEV®

Outcome Measures

Primary Outcomes (8)

• Percentage of Participants With JE Seroprotection Before and Following a Booster Dose of IMOJEV Given One Year After Primary Immunization

  JE virus neutralizing antibodies were measured using a 50% plaque reduction neutralization test (PRNT50). Seroprotection status for antibody levels against JE virus before and after IMOJEV vaccination was defined as antibody titers ≥ 10 (1/dilution).

  Day 0 (pre-booster) and Day 28 post-booster injection

• Percentage of Participants With JE Seroconversion Following a Booster Dose of IMOJEV Given One Year After Primary Immunization

  JE virus neutralizing antibodies were measured using PRNT50. Seroconversion was defined as a pre-vaccination titer \<10 (1/dilution) and post-vaccination titer ≥10 (1/dilution, or pre-vaccination titer ≥10 (1/dilution) and a ≥4-fold increase of titers from pre- to post-vaccination.

  Day 28 post-booster injection

• Summary of Geometric Mean Titers of JE Virus Antibodies Following a Booster Dose of IMOJEV Given One Year After Primary Immunization

  JE virus neutralizing antibodies were measured using PRNT50 test.

  Day 0 (pre-booster) and Day 28 post-booster injection

• Summary of Geometric Mean Titer Ratios of JE Virus Antibodies Following a Booster Dose of IMOJEV Given One Year After Primary Immunization

  JE virus neutralizing antibodies were measured using PRNT50.

  Day 0 (pre-booster) and Day 28 post-booster injection

• Percentage of Participants With JE Seroprotection Before and After a Booster Dose of IMOJEV Given At Different Intervals After Primary Immunization

  JE virus neutralizing antibodies were measured using PRNT50. Seroprotection was defined as neutralizing antibody titer ≥ 10 (1/dilution).

  Day 0 (pre-booster) and Day 28 post-booster injection

• Percentage of Participants With JE Seroconversion Following a Booster Dose of IMOJEV Given At Different Intervals After Primary Immunization

  JE virus neutralizing antibodies were measured using PRNT50. Seroconversion was defined as a pre-vaccination titer \<10 (1/dilution) and post-vaccination titer ≥10 (1/dilution, or pre-vaccination titer ≥10 (1/dilution) and a ≥4 fold increase from pre- to post-vaccination.

  Day 28 post-booster injection

• Summary of Geometric Mean Titers of JE Virus Antibodies Following a Booster Dose of IMOJEV At Different Intervals After Primary Immunization

  JE virus neutralizing antibodies were measured using PRNT50.

  Day 0 (pre-booster) and Day 28 post-booster injection

• Summary of Geometric Mean Titer Ratios of JE Virus Antibodies Following a Booster Dose of IMOJEV Given At Different Intervals After Primary Immunization

  JE virus neutralizing antibodies were measured using PRNT50.

  Day 0 (pre-booster) and Day 28 post-booster injection

Study Arms (1)

IMOJEV Group

EXPERIMENTAL

Participants who received a single dose of IMOJEV in study JEC12 (NCT01396512) will receive a booster dose in this study.

Biological: IMOJEV

Interventions

IMOJEV BIOLOGICAL

0.5 mL, Subcutaneous

Also known as: Japanese Encephalitis Chimeric Virus Vaccine

IMOJEV Group

Eligibility Criteria

• Age: 2 Years - 4 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Must have participated in study JEC12 and received 1 dose of IMOJEV at least 12 months before booster vaccination
• Informed Concent Form signed and dated by parent(s) or another legally acceptable representative(s)
• Subject and parent(s)/legally acceptable representative(s) able to attend all scheduled visits and comply with all study procedures.

You may not qualify if:

• Participation at the time of study enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical study investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the study vaccination
• Known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy
• Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances
• Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
• Receipt of immune globulins, blood or blood-derived products in the past 3 months, that might interfere with the assessment of the immune response
• Previous vaccination against flavivirus disease, including JE, with another vaccine, except with IMOJEV® while participating in JEC12
• Administration of any anti-viral within 2 months preceding Visit 1 and up to the 4 weeks following the study vaccination
• Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following the trial vaccination, except for inactivated influenza vaccination, which may be received at least 2 weeks before the study vaccine
• History of central nervous system disorder or disease, including seizures
• Planned receipt of any JE vaccine during the course of the study
• History of flavivirus infection (confirmed either clinically, serologically or virologically)
• Administration of systemic corticosteroids for more than 2 consecutive weeks within the 4 weeks preceding vaccination
• Thrombocytopenia, contraindicating vaccination
• Febrile illness (temperature ≥38.0°C) or moderate or severe acute illness/infection 3 days before vaccination as well as the day of vaccination, according to Investigator judgment. A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided
• In an emergency setting or hospitalized involuntarily

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (8)

Investigational Site 004

Gyeonggi-do, South Korea

Location

Investigational Site 010

Gyeonggi-do, South Korea

Location

Investigational Site 001

Seoul, South Korea

Location

Investigational Site 005

Seoul, South Korea

Location

Investigational Site 006

Seoul, South Korea

Location

Investigational Site 008

Seoul, South Korea

Location

Investigational Site 009

Seoul, South Korea

Location

Investigational Site 007

Wŏnju, South Korea

Location

Related Links

• Related Info

MeSH Terms

Conditions

Encephalitis, Japanese

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

Results Point of Contact

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

RegistryContactUs@sanofipasteur.com

Study Officials

• Medical Director

  Sanofi Pasteur South Korea

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: July 11, 2013
• First Posted: July 16, 2013
• Study Start: July 11, 2013
• Primary Completion: March 11, 2014
• Study Completion: March 11, 2014
• Last Updated: March 28, 2022
• Results First Posted: December 13, 2017

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share

Locations

KR (8)