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COMPLETEDPHASE2

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

A Phase II, Pilot, Randomized, Open-Label, Single-Center Study to Evaluate Immunogenicity, Safety and Booster Response of 3 Full Intramuscular Doses Versus 3 Half Intramuscular Doses Versus 3 Intradermal Doses Versus 2 Intradermal Doses of PCEC Rabies Vaccine Administered Concomitantly With Japanese Encephalitis Vaccine as a Pre-Exposure Regimen in 12 to 18 Months Old Toddlers in Thailand.

NCT00694460•Novartis

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

1 - 1 years

Sex

ALL

Healthy Volunteers

Yes

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
+4 more criteria

Locations (1)

Tropical Medicine, Mahidol University

Bangkok, Thailand

Key Dates

Start Date

August 1, 2002

Primary Completion Date

August 1, 2004

Completion Date

September 1, 2004

Last Updated

June 10, 2008

Enrollment

200

ACTUAL participants

Conditions

RabiesJapanese EncephalitisPre-Exposure Prophylaxis

Interventions

Three 1 mL doses of Rabies vaccine and two JE vaccine

BIOLOGICAL

Three 0.5 mL doses of Rabies vaccine and two JE vaccine

BIOLOGICAL

Three 0.1mL doses of Rabies Vaccine and two JE vaccine

BIOLOGICAL

Two 0.1mL doses of Rabies vaccine and two JE vaccine

BIOLOGICAL

Two doses of JE vaccine

BIOLOGICAL

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 10, 2008Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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

Inclusion Criteria

Exclusion Criteria

A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)

Client-Centered Care Coordination for Black Men Who Have Sex With Men

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