Japanese Encephalitis, Pre-Exposure Prophylaxis, Rabies
Conditions
Keywords
rabies vaccination, pre-exposure prophylaxis, rabies virus neutralizing antibody
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.
Interventions
BIOLOGICALThree 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)
BIOLOGICALThree 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)
BIOLOGICALThree 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)
BIOLOGICALTwo 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)
BIOLOGICALTwo 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)
Sponsors
Novartis Vaccines
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Months to 18 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rabies virus neutralizing antibody concentrations | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Japanese encephalitis virus neutralizing antibody titers | 2 years |
Countries
Thailand
Outcome results
None listed