NCT00703521

Rabies Immunization Concomitant With JEV in Children

A Three-Year Clinical Study on Immunogenicity, Safety and Booster Response of Purified Chick Embryo Cell Rabies Vaccine (Pcecv) Administered Intramuscularly or Intradermally to 12- to 18-Month-Old Thai Children Concomitantly With Japanese Encephalitis Vaccine

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: 12 Months – 18 Months
• Healthy volunteers: Accepted

Summary

Background. The World Health Organization recommends pre-exposure vaccination (PreP) to protect children living in canine rabies endemic countries. Including PreP in national childhood immunization programs (EPI) is a viable option. Methods. In an open-label phase II clinical trial, 200 healthy toddlers were randomized to receive Purified Chick Embryo Cell Vaccine (PCECV) in a 3-dose Full-IM (1mL), Half-IM (0.5mL), 3-ID (0.1mL), or a 2-dose 2-ID (0.1mL) regimen, all in combination with two doses of Japanese Encephalitis (JEV), or JEV alone. One booster dose of PCECV (IM or ID) and JEV, or JEV alone was administered concomitantly one year after primary vaccination. Safety was evaluated after each injection. Blood was drawn on days 0 and 49, one year later prior to booster and on days 7 and 28 post-booster, and at two and three years post primary vaccination. All sera were analyzed for rabies and JE virus neutralizing antibodies (RVNA, JEVNA).

Conditions

• Rabies

Interventions

Type	Name	Description
BIOLOGICAL	Rabies vaccine	1.0 mL IM day 0,7,28 and 1 year

Timeline

• Start date: 2002-08-01
• Primary completion: 2002-10-01
• Completion: 2005-09-01
• First posted: 2008-06-23
• Last updated: 2008-10-24