Safety and Efficacy Study of ChimeriVax™-JE and JE Inactivated Mouse Brain Vaccine in Children of Descending Age

NCT ID: NCT00441259

Last Updated: 2012-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2011-12-31

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.

Conditions

Japanese Encephalitis

Keywords

Japanese Encephalitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

JE-CV Group

Participants will receive Japanese encephalitis chimeric virus vaccine (JE-CV)

Group Type: EXPERIMENTAL

ChimeriVax™-JE

Intervention Type: BIOLOGICAL

One dose of 4.0 log10 PFU is given in a volume of 1 ml for children aged \> 3 years and 0.5 ml to children and infants aged \< 3 years administered subcutaneously

MBDV Group

Participants will receive the mouse brain-derived vaccine (MBDV)

Group Type: ACTIVE_COMPARATOR

Japanese Encephalitis Inactivated Mouse Brain Vaccine

Intervention Type: BIOLOGICAL

Two doses of 1 ml reconstituted JE-MBDV is given to subjects aged \> 3 years and 0.5 ml is given to children and infants aged \< 3 years administered subcutaneously

Interventions

ChimeriVax™-JE

One dose of 4.0 log10 PFU is given in a volume of 1 ml for children aged \> 3 years and 0.5 ml to children and infants aged \< 3 years administered subcutaneously

Intervention Type: BIOLOGICAL

Japanese Encephalitis Inactivated Mouse Brain Vaccine

Two doses of 1 ml reconstituted JE-MBDV is given to subjects aged \> 3 years and 0.5 ml is given to children and infants aged \< 3 years administered subcutaneously

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 9 Months
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anand Dubey, M.D

Role: PRINCIPAL_INVESTIGATOR

Maulana Azad Medical College, New Delhi, India

Bakul B. Javadekar, M.D.

Role: PRINCIPAL_INVESTIGATOR

Government Medical College, Baroda, India

Atul Shanker, Dr.

Role: PRINCIPAL_INVESTIGATOR

Dr Atul's Child Hospital, Jaipur, Rajasthan, India

Locations

Dr Atul's Child Hospital

Jaipur, Rajasthan, India

Government Medical College

Baroda, , India

Maulana Azad Medical College

New Delhi, , India

Countries

India

Other Identifiers

H-040-004

Identifier Type: -

Identifier Source: org_study_id