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

Phase 2

Completed

• Conditions: Rabies; Japanese Encephalitis; Pre-Exposure Prophylaxis
• Interventions: Biological: 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

• Registration Number: NCT00694460
• Lead Sponsor: Novartis

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-08
• Primary Completion: 2004-08
• Study Completion: 2004-09
• Study First Submitted: 2008-05-30
• Status Verified: 2008-06
• Study First Submitted QC: 2008-06-09
• Last Update Submitted: 2008-06-09
• Study First Posted: 2008-06-10
• Last Update Posted: 2008-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Three 1 mL doses of Rabies vaccine and two JE vaccine	-
2	Three 0.5 mL doses of Rabies vaccine and two JE vaccine	-
3	Three 0.1mL doses of Rabies Vaccine and two JE vaccine	-
4	Two 0.1mL doses of Rabies vaccine and two JE vaccine	-
5	Two doses of JE vaccine	-

Primary Outcome Measures

Name	Time	Method
Rabies virus neutralizing antibody concentrations	2 years

Secondary Outcome Measures

Name	Time	Method
Japanese encephalitis virus neutralizing antibody titers	2 years

Trial Locations

Locations (1)

Tropical Medicine, Mahidol University; 🇹🇭 Bangkok, Thailand