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

Novartis

Status and phase: Completed; Phase 2

Conditions: Japanese Encephalitis; Pre-Exposure Prophylaxis; Rabies

Treatments: Biological: Two doses of JE vaccine; Biological: Three 0.5 mL doses of Rabies vaccine and two JE vaccine; Biological: Three 1 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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00694460

M49P2

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 12 to 18 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 5 patient groups

1

Experimental group

Treatment:

Biological: Three 1 mL doses of Rabies vaccine and two JE vaccine

2

Experimental group

Treatment:

Biological: Three 0.5 mL doses of Rabies vaccine and two JE vaccine

3

Experimental group

Treatment:

Biological: Three 0.1mL doses of Rabies Vaccine and two JE vaccine

4

Experimental group

Treatment:

Biological: Two 0.1mL doses of Rabies vaccine and two JE vaccine

5

Active Comparator group

Treatment:

Biological: Two doses of JE vaccine