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Immunogenicity and Safety of Inactivated Vero Cell Derived Japanese Encephalitis Vaccine in Thai Children

NCT ID: NCT01408537

Last Updated: 2014-11-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2012-12-31

Brief Summary

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Japanese encephalitis (JE) is the main cause of viral encephalitis in many countries of Asia including Thailand. Estimated annual mortality ranges from10,000-15,000 deaths, while the total number of clinical cases is about 50,000. Of these cases, about 50% result in permanent neuropsychiatric sequelae. The disease occurs mostly among children aged \<10 years. There is no specific antiviral treatment for JE. Vaccination is the single most important control measure. This study aims to evaluate the immunogenicity and safety of inactivated Vero cell derived JE vaccine (Beijing P-3 strain) produced by Liaoning Cheng Da Biotechnology Co., Ltd, China "JEVAC" in Thai children.

152 healthy Thai children aged between 1-3 years will be vaccinated with "JEVAC" in a dose of 0.5 mL. subcutaneously on Day 0, 1-4 weeks later and a booster vaccination at one year (totally 3 doses). Two mL. of blood will be drawn on Day 0, 4 weeks after second dose, at one year on booster vaccination day and 4 weeks after the booster (totally 8 mL. of 13 months study period) for determination of JE neutralizing antibodies (PRNT50) using Beijing P3 strain. Adverse events will be observed for 28 days after each vaccination. Serious adverse events will be observed throughout the study period.

Detailed Description

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Conditions

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Encephalitis, Japanese B

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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JEVAC

JEVAC 0.5 mL/ dose subcutaneously injected on upper thigh at D0, 1-4wk, and 1 year

Group Type EXPERIMENTAL

JEVAC

Intervention Type BIOLOGICAL

Each subject will receive 3 doses of JEVAC subcutaneously on Day 0, 1-4 weeks and a booster vaccination at one year. Each dose of JEVAC contains 0.5 mL. of inactivated Vero cell derived JE vaccine (Beijing P-3 strain).

Interventions

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JEVAC

Each subject will receive 3 doses of JEVAC subcutaneously on Day 0, 1-4 weeks and a booster vaccination at one year. Each dose of JEVAC contains 0.5 mL. of inactivated Vero cell derived JE vaccine (Beijing P-3 strain).

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. Healthy Thai children aged 1- 3 years
2. No previous history of JE vaccination
3. Available for all visited schedule in the study period.
4. Written inform consent signed by a parent or guardian

Exclusion Criteria

1. Known serious underlying diseases such as nervous system, heart, kidney and liver diseases.
2. Known hypersensitivity to JE vaccine composition such as human albumin, dextran 40, etc.
3. Previous history of JE disease.
4. Receive the blood component within the past 3 months,
5. Known history of immunocompromised conditions such as HIV/AIDS, malignancy.
6. Under treatment of immunosuppressive drugs such as systemic corticosteroid and anti-neoplastic drug.
7. Febrile illness (temperature ≥37.5°C) or acute illness/infection on the day of vaccination
8. Plan to leave the study area before the end of study period.
9. Participating in other clinical trials.
Minimum Eligible Age

1 Year

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Pornthep Chanthavanich

Department of Tropical Pediatrics, Faculty of Tropical Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pornthep Chanthavanich, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University

Locations

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Department Tropical Pediatrics

Ratchathewi, Bangkok, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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JE0153

Identifier Type: -

Identifier Source: org_study_id