MedTrace Logo

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

NCT01662440 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 661

Last updated 2014-12-08

Study results available
· View outcomes & findings →

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

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.

Sponsors & Collaborators

  • Novartis Vaccines

    lead INDUSTRY

Principal Investigators

  • Novartis Vaccines and Diagnostics · Novartis Vaccines

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2012-12-31
Completion
2013-10-31

Countries

  • Austria
  • Germany
  • Switzerland

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01662440 on ClinicalTrials.gov