CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 661 enrolled
Drug / intervention
Rabies +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01662440
NCT01662440Phase 3Completed

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.

Novartis Vaccines·interventional·Posted Aug 10, 2012·Updated Dec 8, 2014

In Brief

A Phase 3 clinical trial evaluating Rabies, Japanese Encephalitis, and 1 other intervention for Rabies and Japanese Encephalitis. Completed, enrolled 661 participants across 3 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, Germany, Switzerland
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 10, 2012
Enrollment StartAug 1, 2012
Primary CompletionDec 1, 2012
Study CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 13.9 years ago

Interventions

Rabiesbiological

Subjects received three doses of Rabies, whole virus vaccine (inactivated, Germany).

Japanese Encephalitisbiological

Subjects received two doses of Japanese Encephalitis vaccine.

Placeboother

Subjects received either two, three, four or five doses of normal saline, 0.9% w/v sodium chloride depending on the vaccine group.