Early Rabies Vaccine Immunization in Primary School Children

Study Overview
=================
Brief Summary
-----------------
700 male and female healthy school-children (age 5 to 8) in Thailand were randomized to receive 2 or 3 primary rabies vaccine doses (PCECV, Rabipur) given intradermally in a dose of 0.1mL into the skin in the deltoid region. In a subset of 100 children blood was taken for rabies virus neutralizing antibody determination on day 49. All subjects were randomized to receive 2 booster doses (the recommended vaccination schedule for pre-immunized individuals in case of an exposure) on days 0 and 3, one, three or five years later. Blood was taken before and after booster for up to one year.Safety and tolerability of the vaccine was assessed and persistence of immune response up to 1 year after the booster doses.

Official Title
-----------------
Compare Immunogenicity, Safety and Long-term Booster Response After Primary Vaccination With 2 Intradermal Doses Versus 3 Intradermal Doses of PCEC Rabies Vaccine (Rabipur) in Healthy School Children in Thailand (5-8 Years of Age)

Conditions
-----------------
Rabies Prevention

Intervention / Treatment
-----------------
* Biological: rabies vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Male and female 5-8 years old school children will be included in the study if: Their parents or legal guardians have given the written informed consent prior to study entry; They are in good health at time of study entry as determined by medical history, physical examination and clinical judgment of the investigator; They are available for all the visits scheduled in the study. Exclusion criteria: Subjects are not to be enrolled into the study if: They have a history of rabies immunization; They have an acute infectious disease at the time of study entry; They are under treatment with parenteral and/or oral steroids, immunosuppressive drugs, phenytoin or other specific anti-inflammatory drugs, or have taken chloroquine during the two month period before enrolment; They have a known immunodeficiency or an autoimmune disease; They have a known hypersensitivity to neomycin, tetracycline or amphotericin-B; They have planned surgery during the first study period (49 days); They are participating in any other trial of an investigational agent; They have any condition which in the opinion of the investigator, might interfere with the evaluation of the study objectives. The family plans to leave the area of the study site before the end of the study period.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 8 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2 primary ID doses<br>two doses of rabies vaccines given intradermally on days 0 and 28 | Biological: rabies vaccine<br>* intradermal vaccination<br>* Other names: PCECV, Rabipur;|
| Experimental: 3 primary ID doses<br>three doses of rabies vaccines given intradermally on days 0, 7, and 28 | Biological: rabies vaccine<br>* intradermal vaccination<br>* Other names: PCECV, Rabipur;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rabies virus neuralizing antibody, assessed by RFFIT | rabies virus neuralizing antibody concentrations were measured in serum samples using the rapid fluorescent focus inhibition test (RFFIT) | seven days after the first booster dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rabies virus neuralizing antibody, assessed by RFFIT | rabies virus neuralizing antibody concentrations were measured in serum samples using the rapid fluorescent focus inhibition test (RFFIT) | one year after the first booster dose | 
| rabies virus neuralizing antibody, assessed by RFFIT | rabies virus neuralizing antibody concentrations were measured in serum samples using the rapid fluorescent focus inhibition test (RFFIT) | immediately before administration of the first booster dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rabies, PCECV, pre-exposure immunization, intradermal, children