NCT01662440

Safety and Immunogenicity of 2 Different Vaccination Schedules of Rabies and Japanese Encephalitis Vaccines in Healthy Adult Subjects

A Phase III, Multicenter, Observer-blind, Safety and Immunogenicity Study of Rabies Vaccine and Japanese Encephalitis Vaccine Administered Concomitantly and/or Separately According to 1 of 2 Different Preexposure Prophylaxis Schedules to Healthy Adult Subjects.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 661 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Establish non-inferiority of the immune response and evaluate the safety and tolerability of Rabies and Japanese Encephalitis (JE) vaccines given concomitantly or alone and according to either of 2 schedules for preexposure prophylaxis.

Conditions

• Rabies
• Japanese Encephalitis

Interventions

Type	Name	Description
BIOLOGICAL	Rabies	Subjects received three doses of Rabies, whole virus vaccine (inactivated, Germany).
BIOLOGICAL	Japanese Encephalitis	Subjects received two doses of Japanese Encephalitis vaccine.
OTHER	Placebo	Subjects received either two, three, four or five doses of normal saline, 0.9% w/v sodium chloride depending on the vaccine group.

Timeline

• Start date: 2012-08-01
• Primary completion: 2012-12-01
• Completion: 2013-10-01
• First posted: 2012-08-10
• Last updated: 2014-12-08
• Results posted: 2014-12-08

Locations

3 sites across 3 countries: Austria, Germany, Switzerland