Clinical trial NCT00694460: Evalution of Immunogenicity, Safety and Booster Response of a Rabies Vaccine Administered Concomitantly With Japanese Encephalitis Vaccine in Toddlers
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rabies
Japanese Encephalitis
Pre-Exposure Prophylaxis
Keywords: rabies vaccination
pre-exposure prophylaxis
rabies virus neutralizing antibody
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Novartis Vaccines
First posted: 2008-06-10
Enrollment: 200
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Rabies virus neutralizing antibody concentrations
timeFrame: 2 years
Secondary outcomes:
measure: Japanese encephalitis virus neutralizing antibody titers
timeFrame: 2 years
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Tropical Medicine, Mahidol University
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines
role: STUDY_CHAIR
References: