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

NCT00694460 | Completed Phase 2

• 1 other identifier: M49P2
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Rabies; Japanese Encephalitis; Pre-Exposure Prophylaxis

Keywords

rabies vaccination; pre-exposure prophylaxis; rabies virus neutralizing antibody

Outcome Measures

Primary Outcomes (1)

• Rabies virus neutralizing antibody concentrations

  2 years

Secondary Outcomes (1)

• Japanese encephalitis virus neutralizing antibody titers

  2 years

Study Arms (5)

1

EXPERIMENTAL

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

2

EXPERIMENTAL

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

3

EXPERIMENTAL

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

4

EXPERIMENTAL

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

5

ACTIVE COMPARATOR

Biological: Two doses of JE vaccine

Interventions

Three 1 mL doses of Rabies vaccine and two JE vaccine 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)

1

Three 0.5 mL doses of Rabies vaccine and two JE vaccine 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)

2

Three 0.1mL doses of Rabies Vaccine and two JE vaccine 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)

3

Two 0.1mL doses of Rabies vaccine and two JE vaccine 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)

4

Two doses of JE vaccine 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)

5

Eligibility Criteria

• Age: 12 Months - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis: lead
• Novartis Vaccines: collaborator

Study Sites (1)

Tropical Medicine, Mahidol University

Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Rabies; Encephalitis, Japanese

Condition Hierarchy (Ancestors)

Rhabdoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections; Encephalitis, Arbovirus; Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infectious Encephalitis; Arbovirus Infections; Vector Borne Diseases; Mosquito-Borne Diseases; Flavivirus Infections; Flaviviridae Infections; Encephalitis; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases

Study Officials

• Novartis Vaccines

  Novartis Vaccines

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 30, 2008
• First Posted: June 10, 2008
• Study Start: August 1, 2002
• Primary Completion: August 1, 2004
• Study Completion: September 1, 2004
• Last Updated: June 10, 2008

Record last verified: 2008-06

Locations

TH (1)