Clinical trial NCT00441259: Safety and Efficacy Study of ChimeriVax™-JE and JE Inactivated Mouse Brain Vaccine in Children of Descending Age
Official title: Randomised, Double Blind, Controlled, Safety, Tolerability and Immunogenicity Phase II Trial of ChimeriVax™-JE and Japanese Encephalitis Inactivated Mouse Brain Vaccine in Children of Descending Age.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Japanese Encephalitis
Keywords: Japanese Encephalitis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-02-28
Enrollment: 96
Sex: ALL
Minimum age (years): 9
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This randomised, double-blind study is to be conducted on 96 subjects at multiple sites in India. Subjects will be enrolled by age group and randomised to either ChimeriVax™-JE (JE-CV) or JE Mouse Brain Derived Vaccine (JE-MBDV). Study consists of a screening period, a treatment period and a 2 year follow-up period.

Primary safety endpoints will be the adverse event (AE) rates 28 days after completion of vaccination course. The primary efficacy endpoints will be the rate of seroconversion 28 days after completing vaccination.


Eligibility criteria: Inclusion Criteria:

* All aspects of the Protocol explained and written informed consent obtained from the subject's parent or guardian and assent from the child if ≥ 8 years of age.
* Aged ≥ 9 months to \< 10 years
* In good general health, without significant medical history, physical examination findings, or clinically significant abnormal laboratory results
* Subject had to be available for the study duration for the study duration, including all planned follow-up visits.

Exclusion Criteria:

* A history of vaccination against, or infection with, JE or other flaviviruses (e.g. Kyanasur Forest Disease, West Nile virus, dengue fever). Previous JE vaccination was to be determined by history (interview of subject's parent or guardian) or by inspecting the child's official vaccination record.
* Demonstration of parasitemia on malaria blood smear at Screening.
* History of residence in or travel to a JE-endemic region of India or elsewhere in Asia (for periods of 4 weeks or more).
* hypersensitivity to thimerosal or gelatin
* Have received a transfusion of blood, blood products or serum globulin in the preceding 6 months,
* Have an immunodeficiency or neurological disorder, or take drugs that suppress the immune system,
* Have a history of severe reaction to other vaccines,
* Have a chronic condition requiring medication,
* Intend to travel out of the area during the study period,
* Have spent at least 4 weeks in a JE-endemic region,
* Plan to receive any other vaccination within the double-blind treatment period, or who have received a vaccination in the month preceding Screening,
* Exhibit signs of secondary or tertiary malnutrition,
* Are seropositive to human immunodeficiency virus (HIV), Hepatitis B or C,
* Have malaria infection, or who have a fever within 3 days before vaccination.
* Those with an acute fever, or with previously scheduled vaccinations, may be rescheduled.
* Consideration of the routine immunisation schedule should be made such that it is ensured that routine vaccinations due are either given before entry to the trial, or afterwards if delayed because of the trial.

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
timeFrame: Day 14 up to Day 42 Post-vaccination
measure: Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
timeFrame: Day 14 up to Day 42 Post-vaccination
measure: Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
timeFrame: Day 42 Post-vaccination
measure: Geometric Mean Titers (GMTs) of Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
timeFrame: Day 42 Post Dose 1
Secondary outcomes:
measure: Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
timeFrame: Day 42 Post Dose 1
measure: Geometric Mean Titers (GMTs) Using Neutralizing Antibody to Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
timeFrame: Day 42 Post-vaccination
Other outcomes:
Locations:
city: Jaipur
country: India
facility: Dr Atul's Child Hospital
state: Rajasthan
city: Baroda
country: India
facility: Government Medical College
city: New Delhi
country: India
facility: Maulana Azad Medical College
Study officials:
affiliation: Maulana Azad Medical College, New Delhi, India
name: Anand Dubey, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Government Medical College, Baroda, India
name: Bakul B. Javadekar, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Dr Atul's Child Hospital, Jaipur, Rajasthan, India
name: Atul Shanker, Dr.
role: PRINCIPAL_INVESTIGATOR
References: