A Phase II, Pilot, Randomized, Open-Label, Single-Center Study to Evaluate Immunogenicity, Safety and Booster Response of 3 Full Intramuscular Doses Versus 3 Half Intramuscular Doses Versus 3 Intradermal Doses Versus 2 Intradermal Doses of PCEC Rabies Vaccine Administered Concomitantly With Japanese Encephalitis Vaccine as a Pre-Exposure Regimen in 12 to 18 Months Old Toddlers in Thailand.

NCT00694460 Phase 2 COMPLETED

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.

Details

Lead sponsor	Novartis
Phase	Phase 2
Status	COMPLETED
Enrolment	200
Start date	2002-08
Completion	2004-09

Conditions

• Rabies
• Japanese Encephalitis
• Pre-Exposure Prophylaxis

Interventions

• Three 1 mL doses of Rabies vaccine and two JE vaccine
• Three 0.5 mL doses of Rabies vaccine and two JE vaccine
• Three 0.1mL doses of Rabies Vaccine and two JE vaccine
• Two 0.1mL doses of Rabies vaccine and two JE vaccine
• Two doses of JE vaccine

Primary outcomes

• Rabies virus neutralizing antibody concentrations — 2 years

Countries

Thailand