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

• ClinicalTrials.gov Identifier: NCT00694460
• Recruitment Status: Completed
• First Posted: June 10, 2008
• Last Update Posted: June 10, 2008
• Sponsor: Novartis
• Collaborator: Novartis Vaccines
• Information provided by: Novartis

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Rabies; Japanese Encephalitis; Pre-Exposure Prophylaxis	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	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: 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.
• Study Start Date: August 2002
• Actual Primary Completion Date: August 2004
• Actual Study Completion Date: September 2004

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1	Biological: 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)
Experimental: 2	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)
Experimental: 3	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)
Experimental: 4	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)
Active Comparator: 5	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)

Outcome Measures

Primary Outcome Measures :

1. Rabies virus neutralizing antibody concentrations [ Time Frame: 2 years ]

Secondary Outcome Measures :

1. Japanese encephalitis virus neutralizing antibody titers [ Time Frame: 2 years ]

Eligibility Criteria

• Ages Eligible for Study: 12 Months to 18 Months (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

Thailand

Tropical Medicine, Mahidol University

Bangkok, Thailand, 10400

Sponsors and Collaborators

Novartis

Novartis Vaccines

Investigators

• Study Chair: Novartis Vaccines; Novartis Vaccines

More Information

• Responsible Party: Novartis, Novartis Vaccines
• ClinicalTrials.gov Identifier: NCT00694460
• Other Study ID Numbers: M49P2
• First Posted: June 10, 2008
• Last Update Posted: June 10, 2008
• Last Verified: June 2008

Keywords provided by Novartis:

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

Additional relevant MeSH terms:

Rabies; Encephalitis, Japanese; Encephalitis; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Rhabdoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Encephalitis, Arbovirus; Arbovirus Infections; Encephalitis, Viral; Central Nervous System Viral Diseases; Flavivirus Infections; Flaviviridae Infections; Infectious Encephalitis; Central Nervous System Infections; Vaccines; Immunologic Factors; Physiological Effects of Drugs