Study of ChimeriVax™-Japanese Encephalitis Vaccine in Toddlers in Thailand and the Philippines

April 1, 2015 updated by: Sanofi Pasteur, a Sanofi Company

Lot-to-lot Consistency, Bridging, and Safety Trial of ChimeriVax™-Japanese Encephalitis Vaccine in Toddlers in Thailand and the Philippines

This study is to assess the safety and immunogenicity of three consecutive lots of JE-CV in toddlers aged 12-18 months.

Primary objective:

To demonstrate the bio-equivalence of three lots of JE-CV vaccine manufactured by sanofi pasteur.

Secondary objective:

To describe the safety of vaccination in all subjects

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a Phase III trial in toddlers in Thailand and the Philippines.

Study Type

Interventional

Enrollment (Actual)

1200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Philippines
      • Alabang, Philippines
      • Bayanan, Philippines
      • Buli, Philippines
      • Cupang, Philippines
      • Sucat, Philippines
  • Thailand
      • Bangkok, Thailand, 10400
      • Bangkok, Thailand, 10330
      • Khon Kaen, Thailand, 40002

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 1 year (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria :

  • Aged 12 to 18 months on the day of inclusion.
  • In good general health, without significant medical history.
  • Provision of informed consent form signed by at least one parent or other legally acceptable representative, and by at least one independent witness if required by local regulations.
  • Subject and parent/legally acceptable representative able to attend all scheduled visits and comply with all trial procedures.
  • Completion of vaccinations according to the national immunization schedule.

Exclusion Criteria :

  • Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the trial vaccination.
  • Planned participation in another clinical trial during the present trial period.
  • 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 systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing any of the same substances.
  • Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
  • Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of the immune response.
  • Administration of any anti-viral within 2 months preceding V01.
  • History of central nervous system disorder or disease, including seizures.
  • Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia.
  • Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.
  • Planned receipt of any vaccine in the 4 weeks following any trial vaccination.
  • Personal human immunodeficiency virus seropositivity in the blood sample taken at screening.
  • Receipt of any JE vaccine or hepatitis A vaccine.
  • Previous vaccination against flavivirus disease.
  • History of flavivirus infection (confirmed either clinically, serologically or microbiologically)
  • Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular vaccination.
  • Febrile illness (temperature ≥38°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: JE-CV GPO MBP (Lot 1)
Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO-MBP) Lot 1.
Biological: Japanese encephalitis vaccine
0.5 mL, Subcutaneous
Other Names:
  • ChimeriVax™-JE
EXPERIMENTAL: JE-CV GPO MBP (Lot 2)
Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO-MBP) Lot 2.
Biological: Japanese encephalitis vaccine
0.5 mL, Subcutaneous
Other Names:
  • ChimeriVax™-JE
EXPERIMENTAL: JE-CV GPO MBP (Lot 3)
Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO-MBP) Lot 3.
Biological: Japanese encephalitis vaccine
0.5 mL, Subcutaneous
Other Names:
  • ChimeriVax™-JE
ACTIVE_COMPARATOR: JE-CV WRAIR (Group 4)
Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)
Biological: Japanese encephalitis vaccine (Acambis)
0.5 mL, Subcutaneous
SHAM_COMPARATOR: Hepatitis A (Group 5)
Participants 12 to 18 months of age randomized to receive Hepatitis A vaccine
Biological: Hepatitis A vaccine
0.5 mL, Intramuscular
Other Names:
  • Avaxim® 80U Pediatric

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Seroconversion to Vaccine Antigens Following Vaccination With JE-CV by GPO MBP Lots
Time Frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Anti-Japanese encephalitis chimeric virus vaccine antibodies were measured using the 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as participants with a pre-vaccination titer <10 1/dil and post-vaccination titer ≥ 10 1/dil, or participants with pre-vaccination titer ≥ 10 1/dil and 4-fold increase from pre- to post-vaccination.
Day 0 (pre-vaccination) and Day 28 post-vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or Walter Reed Army Institute of Research (WRAIR) JE-CV
Time Frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Anti-Japanese Encephalitis Chimeric Virus antibodies were measured using the 50% plaque reduction neutralization test (PRNT50) assay.
Day 0 (pre-vaccination) and Day 28 post-vaccination
Number of Participants With Seroprotection to Japanese Encephalitis Chimeric Virus Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or WRAIR JE-CV
Time Frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Anti-Japanese encephalitis chimeric virus vaccine antibodies were measured using the PRNT50 assay. Seroprotection was defined as the proportion of subjects with a JE CV virus PRNT50 neutralizing antibody titer ≥10 1/dilution (dil).
Day 0 (pre-vaccination) and Day 28 post-vaccination
Geometric Mean Titers Ratios Against the Japanese Encephalitis Chimeric Virus (JE-CV) Antigen Following Vaccination With One of the JE-CV by GPO MBP Lots or WRAIR JE-CV Vaccine
Time Frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Anti Japanese encephalitis chimeric virus antibodies were measured using the PRNT50 assay.
Day 0 (pre-vaccination) and Day 28 post-vaccination
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine.
Time Frame: Day 0 up to Day 14 post-vaccination
Solicited injection site: Tenderness, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability. Grade 3 injection site: Tenderness, cries when injected limb is moved or the movement of injected limb is reduced; Erythema and Swelling ≥5 cm. Grade 3 systemic reactions: Fever, temperature >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 up; Appetite Lost, refuses ≥3 or most feeds/meals; and Irritability, inconsolable.
Day 0 up to Day 14 post-vaccination

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serological Status of Flavivirus Infection at Baseline (Before) Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Hepatitis A Vaccine.
Time Frame: Day 0 (pre-vaccination)
Flavivirus (FV) positive was defined as anti-JE against homologous virus strain ≥10 l/dil or anti dengue against at least one serotype ≥10 l/dil. FV negative was defined as anti-JE against homologous virus strain <10 l/dil and anti-dengue against the 4 serotypes <10 l/dilution.
Day 0 (pre-vaccination)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi Pasteur, a Sanofi Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (ACTUAL)

May 1, 2009

Study Completion (ACTUAL)

August 1, 2009

Study Registration Dates

First Submitted

August 14, 2008

First Submitted That Met QC Criteria

August 14, 2008

First Posted (ESTIMATE)

August 15, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

April 21, 2015

Last Update Submitted That Met QC Criteria

April 1, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JEC02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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