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Evalution of Immunogenicity, Safety and Booster Response of a Rabies Vaccine Administered Concomitantly With Japanese Encephalitis Vaccine in Toddlers

NCT ID: NCT00694460

Last Updated: 2008-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-08-31

Study Completion Date

2004-09-30

Brief Summary

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This study evaluated the safety and immunogenicity of rabies vaccine and Japanese encephalitis vaccine in toddlers. All children developed adequate immune responses. Rabies vaccination with PCECV did not interfere with the antibody response to Japanese encephalitis vaccine. The rabies vaccine PCECV and Japanese encephalitis vaccine are safe and immunogenic when administered concomitantly to toddlers.

Detailed Description

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Conditions

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Rabies Japanese Encephalitis Pre-Exposure Prophylaxis

Keywords

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rabies vaccination pre-exposure prophylaxis rabies virus neutralizing antibody

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Three 1 mL doses of Rabies vaccine and two JE vaccine

Intervention Type BIOLOGICAL

Vaccination with purified chick embryo cell rabies vaccine 1.0 mL intramuscularly on Day 0, Day 7 and Day 28 (a total of 3 doses) and Beijing 1 strain of inactivated, lyophilized Japanese Encephalitis vaccine 0.25 mL subcutaneously on Day 0 and Day 7 (a total of 2 doses)

2

Group Type EXPERIMENTAL

Three 0.5 mL doses of Rabies vaccine and two JE vaccine

Intervention Type BIOLOGICAL

Vaccination with purified chick embryo cell rabies vaccine 0.5 mL intramuscularly on Day 0, Day 7 and Day 28 (a total of 3 doses) and Beijing 1 strain of inactivated, lyophilized Japanese Encephalitis vaccine 0.25 mL subcutaneously on Day 0 and Day 7 (a total of 2 doses)

3

Group Type EXPERIMENTAL

Three 0.1mL doses of Rabies Vaccine and two JE vaccine

Intervention Type BIOLOGICAL

Vaccination with purified chick embryo cell rabies vaccine 0.1 mL intradermally at one site on Day 0, Day 7 and Day 28 (a total of 3 doses) and Beijing 1 strain of inactivated, lyophilized Japanese Encephalitis vaccine 0.25 mL subcutaneously on Day 0 and Day 7 (a total of 2 doses)

4

Group Type EXPERIMENTAL

Two 0.1mL doses of Rabies vaccine and two JE vaccine

Intervention Type BIOLOGICAL

Vaccination with purified chick embryo cell rabies vaccine 0.1 mL intradermally at one site on Day 0 and Day 28 (a total of 2 doses) and Beijing 1 strain of inactivated, lyophilized Japanese Encephalitis vaccine 0.25 mL subcutaneously on Day 0 and Day 7 (a total of 2 doses)

5

Group Type ACTIVE_COMPARATOR

Two doses of JE vaccine

Intervention Type BIOLOGICAL

Vaccination with Beijing 1 strain of inactivated, lyophilized Japanese Encephalitis vaccine 0.25 mL only subcutaneously on Day 0 and Day 7 (a total of 2 doses)

Interventions

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Three 1 mL doses of Rabies vaccine and two JE vaccine

Vaccination with purified chick embryo cell rabies vaccine 1.0 mL intramuscularly on Day 0, Day 7 and Day 28 (a total of 3 doses) and Beijing 1 strain of inactivated, lyophilized Japanese Encephalitis vaccine 0.25 mL subcutaneously on Day 0 and Day 7 (a total of 2 doses)

Intervention Type BIOLOGICAL

Three 0.5 mL doses of Rabies vaccine and two JE vaccine

Vaccination with purified chick embryo cell rabies vaccine 0.5 mL intramuscularly on Day 0, Day 7 and Day 28 (a total of 3 doses) and Beijing 1 strain of inactivated, lyophilized Japanese Encephalitis vaccine 0.25 mL subcutaneously on Day 0 and Day 7 (a total of 2 doses)

Intervention Type BIOLOGICAL

Three 0.1mL doses of Rabies Vaccine and two JE vaccine

Vaccination with purified chick embryo cell rabies vaccine 0.1 mL intradermally at one site on Day 0, Day 7 and Day 28 (a total of 3 doses) and Beijing 1 strain of inactivated, lyophilized Japanese Encephalitis vaccine 0.25 mL subcutaneously on Day 0 and Day 7 (a total of 2 doses)

Intervention Type BIOLOGICAL

Two 0.1mL doses of Rabies vaccine and two JE vaccine

Vaccination with purified chick embryo cell rabies vaccine 0.1 mL intradermally at one site on Day 0 and Day 28 (a total of 2 doses) and Beijing 1 strain of inactivated, lyophilized Japanese Encephalitis vaccine 0.25 mL subcutaneously on Day 0 and Day 7 (a total of 2 doses)

Intervention Type BIOLOGICAL

Two doses of JE vaccine

Vaccination with Beijing 1 strain of inactivated, lyophilized Japanese Encephalitis vaccine 0.25 mL only subcutaneously on Day 0 and Day 7 (a total of 2 doses)

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Male and female 12-18 months old toddlers if they
* are in good health at time of entry into the study
* are available for all the visits scheduled in the study
* have been granted a written informed consent, signed by their parents

Exclusion Criteria

* a history of rabies immunization
* a history of Japanese encephalitis immunization or disease
* a significant acute or chronic infectious disease at the time of enrollment
* fever ≥ 38.0°C (axillary) or/and significant acute or chronic infection requiring antibiotic or antiviral therapy within the past 7 days before enrollment
* being under treatment with corticosteroids, immunosuppressive drugs or other specific anti-inflammatory drugs or having taken chloroquine during the two months period before enrollment
* administration of any vaccine within the past 14 days before enrollment
* known immunodeficiency or an autoimmune disease
* history of allergy to eggs, egg products
* known hypersensitivity to neomycin, tetracycline, amphotericin-B
* planned surgery during the study period
* being enrolled in any other investigational trial contemporaneously
* the family plans to leave the area of the study site before the end of study period
* history of febrile convulsions
* history of wheezing
Minimum Eligible Age

12 Months

Maximum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis Vaccines

INDUSTRY

Sponsor Role collaborator

Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Novartis Vaccines

Principal Investigators

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Novartis Vaccines

Role: STUDY_CHAIR

Novartis Vaccines

Locations

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Tropical Medicine, Mahidol University

Bangkok, , Thailand

Site Status

Countries

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Thailand

Other Identifiers

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M49P2

Identifier Type: -

Identifier Source: org_study_id