Early Rabies Vaccine Immunization in Primary School Children

NCT ID: NCT01107275

Last Updated: 2010-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 703 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-11-30
• Study Completion Date: 2008-11-30

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.

Conditions

Rabies Prevention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

2 primary ID doses

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

Group Type: EXPERIMENTAL

rabies vaccine

Intervention Type: BIOLOGICAL

intradermal vaccination

3 primary ID doses

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

Group Type: EXPERIMENTAL

rabies vaccine

Intervention Type: BIOLOGICAL

intradermal vaccination

Interventions

rabies vaccine

intradermal vaccination

Intervention Type: BIOLOGICAL

Other Intervention Names

PCECV, Rabipur

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Provincial Public Health Office, Phetchabun

OTHER_GOV

Sponsor Role: lead

Responsible Party

Ministry of health

Principal Investigators

Thavatchai Kamoltham, MD

Role: PRINCIPAL_INVESTIGATOR

Provincial PHO

Locations

Phetchabun Province primary schools

Phetchabun, Phetchabun, Thailand

Countries

Thailand

References

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.

Reference Type: RESULT

PMID: 17643772 (View on PubMed)

Other Identifiers

I49P1

Identifier Type: -

Identifier Source: org_study_id