Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00735644
First received: August 14, 2008
Last updated: July 25, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
Japanese Encephalitis
Hepatitis A
Biological: Japanese encephalitis vaccine
Biological: Japanese encephalitis vaccine (Acambis)
Biological: Hepatitis A vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Lot-to-lot Consistency, Bridging, and Safety Trial of ChimeriVax™-Japanese Encephalitis Vaccine in Toddlers in Thailand and the Philippines

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Anti-Japanese Encephalitis Chimeric Virus antibodies were measured using the 50% plaque reduction neutralization test (PRNT50) assay.

  • 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 ] [ Designated as safety issue: No ]
    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).

  • 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 ] [ Designated as safety issue: No ]
    Anti Japanese encephalitis chimeric virus antibodies were measured using the PRNT50 assay.

  • 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 ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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.


Enrollment: 1200
Study Start Date: August 2008
Study Completion Date: August 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: Avaxim® 80U Pediatric

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   12 Months to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00735644

Locations
Philippines
Alabang, Philippines
Bayanan, Philippines
Buli, Philippines
Cupang, Philippines
Sucat, Philippines
Thailand
Bangkok, Thailand, 10400
Bangkok, Thailand, 10330
Khon Kaen, Thailand, 40002
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Monitor Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00735644     History of Changes
Other Study ID Numbers: JEC02
Study First Received: August 14, 2008
Results First Received: June 25, 2014
Last Updated: July 25, 2014
Health Authority: Philippines: Department of Health
Thailand: Food and Drug Administration

Keywords provided by Sanofi:
Japanese encephalitis, Hepatitis A, Inactivated Mouse-Brain

Additional relevant MeSH terms:
Encephalitis, Japanese
Encephalitis
Hepatitis
Hepatitis A
Arbovirus Infections
Brain Diseases
Central Nervous System Diseases
Central Nervous System Infections
Central Nervous System Viral Diseases
Digestive System Diseases
Encephalitis, Arbovirus
Encephalitis, Viral
Enterovirus Infections
Flaviviridae Infections
Flavivirus Infections
Hepatitis, Viral, Human
Liver Diseases
Nervous System Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 27, 2014