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Early Rabies Vaccine Immunization in Primary School Children (I49P1)

Primary Purpose

Rabies Prevention

Status

Completed

Phase

Phase 3

Locations

Thailand

Study Type

Interventional

Intervention

rabies vaccine

About this trial

This is an interventional prevention trial for Rabies Prevention focused on measuring Rabies, PCECV, pre-exposure immunization, intradermal, children

Eligibility Criteria

5 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Phetchabun Province primary schools

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

2 primary ID doses

3 primary ID doses

Arm Description

two doses of rabies vaccines given intradermally on days 0 and 28

three doses of rabies vaccines given intradermally on days 0, 7, and 28

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)

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)

Full Information

NCT ID

NCT01107275

First Posted

April 16, 2010

Last Updated

April 19, 2010

Sponsor

Provincial Public Health Office, Phetchabun

1. Study Identification

Unique Protocol Identification Number

NCT01107275

Brief Title

Early Rabies Vaccine Immunization in Primary School Children

Acronym

I49P1

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)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2010

Overall Recruitment Status

Completed

Study Start Date

November 2002 (undefined)

Primary Completion Date

November 2004 (Actual)

Study Completion Date

November 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Provincial Public Health Office, Phetchabun

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rabies Prevention

Keywords

Rabies, PCECV, pre-exposure immunization, intradermal, children

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

703 (Actual)

8. Arms, Groups, and Interventions

Arm Title

2 primary ID doses

Arm Type

Experimental

Arm Description

two doses of rabies vaccines given intradermally on days 0 and 28

Arm Title

3 primary ID doses

Arm Type

Experimental

Arm Description

three doses of rabies vaccines given intradermally on days 0, 7, and 28

Intervention Type

Biological

Intervention Name(s)

rabies vaccine

Other Intervention Name(s)

PCECV, Rabipur

Intervention Description

intradermal vaccination

Primary Outcome Measure Information:

Title

rabies virus neuralizing antibody, assessed by RFFIT

Description

rabies virus neuralizing antibody concentrations were measured in serum samples using the rapid fluorescent focus inhibition test (RFFIT)

Time Frame

seven days after the first booster dose

Secondary Outcome Measure Information:

Title

rabies virus neuralizing antibody, assessed by RFFIT

Description

rabies virus neuralizing antibody concentrations were measured in serum samples using the rapid fluorescent focus inhibition test (RFFIT)

Time Frame

one year after the first booster dose

Title

rabies virus neuralizing antibody, assessed by RFFIT

Description

rabies virus neuralizing antibody concentrations were measured in serum samples using the rapid fluorescent focus inhibition test (RFFIT)

Time Frame

immediately before administration of the first booster dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

8 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thavatchai Kamoltham, MD

Organizational Affiliation

Provincial PHO

Official's Role

Principal Investigator

Facility Information:

Facility Name

Phetchabun Province primary schools

City

Phetchabun

Country

Thailand

12. IPD Sharing Statement

Citations:

PubMed Identifier

17643772

Citation

Kamoltham T, Thinyounyong W, Phongchamnaphai P, Phraisuwan P, Khawplod P, Banzhoff A, Malerczyk C. Pre-exposure rabies vaccination using purified chick embryo cell rabies vaccine intradermally is immunogenic and safe. J Pediatr. 2007 Aug;151(2):173-7. doi: 10.1016/j.jpeds.2007.02.044.

Results Reference

result

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Early Rabies Vaccine Immunization in Primary School Children

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