Safety and Immunogenicity Study of Rabies Vaccine and Japanese Encephalitis Vaccine Administered Together and/or Separately According to Different Schedules to Healthy 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 Pre-exposure Prophylaxis Schedules to Healthy Adult Subjects

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005173-23-DE

Enrollment

660

Registered

2012-01-25

Start date

2012-04-30

Completion date

Unknown

Last updated

2012-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Safety and Immunogenicity of Rabies Vaccine and Japanese Encephalitis Vaccine administered concomitantly and/or separately according to 1 of 2 different pre-exposure prophylaxis schedules to healthy adult subjects MedDRA version: 14.1 Level: PT Classification code 10037742 Term: Rabies System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1 Level: LLT Classification code 10023123 Term: Japanese encephalitis System Organ Class: 10021881 - Infections and infestations Med

Interventions

Trade Name: Rabipur Product Name: Rabipur Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Rabies virus (inactivated, strain Flury LEP) Other descriptive name: R

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Males and females between 18 and 65 years of age (inclusive) 2. Subjects who have given written consent after the nature of the study has been explained according to local regulatory requirements. 3. Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator. 4. Individuals who have access to a touch key telephone and are able to use the eDiary to record safety assessments as required by the protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 660 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. History of previous rabies/rabies immune globulin and/or JE immunization. 2. Any individuals with a contraindication or precaution against vaccination with Rabipur® or IXIARO® as highlighted in the package inserts of these products 3. Subjects currently receiving or planning to receive anti-malarial medications (e.g. Mefloquine) 14 days prior to Day 1 vaccination through Day 43.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the safety and tolerability of Rabies and JE vaccines given concomitantly or alone and according to either of 2 schedules for pre-exposure prophylaxis To compare descriptively the safety data collected by eDiary (via telephone) to the safety data recorded in paper diaries. Immunogenicity: Primary: 1. To establish non-inferiority of the immune response of Rabies vaccine (administered concomitantly with JE vaccine) accelerated schedule as compared to conventional schedule. 2. To establish non-inferiority of the immune response of JE vaccine (administered concomitantly with Rabies vaccine), accelerated schedule as compared to conventional schedule. ;Secondary Objective: 1. Establish non-inferiority of the Rabies vaccine immune response (with JE vaccine) versus Rabies vaccine alone in a Conventional vaccination schedule. 2. Establish non-inferiority of the immune response of JE vaccine (with Rabies vaccine) versus JE vaccine alone in a Conventional vaccination schedule. 3. Establish non-inferiority of the immune response of Rabies vaccine (with JE vaccine) given in an Accelerated schedule versus Rabies vaccine alone in a Conventional vaccination schedule. 4. Establish non-inferiority of the immune response of JE vaccine (with Rabies vaccine) in an Accelerated schedule versus JE vaccine alone in a Conventional vaccination schedule. 5. Evaluate antibody response kinetics in groups receiving Rabies vaccine measured by rapid fluorescent focus inhibition test (RFFIT) 6. Evaluate antibody response kinetics in groups receiving JE vaccine. ;Primary end point(s): Percentage of subjects with RVNA titer = 0.5 IU/mL Percentage of subjects with PRNT50 titer = 1:10 Safety Endpoints: Solicited local and systemic reactions, adverse event collection (including SAE collection), and concomitant medication collection.;Timepoint(s) of evaluation of this end point: For RVNA titer: 7 days after the last active vaccine administration. For PRNT50 t	—

Measure

Time frame

Main Objective: To evaluate the safety and tolerability of Rabies and JE vaccines given concomitantly or alone and according to either of 2 schedules for pre-exposure prophylaxis To compare descriptively the safety data collected by eDiary (via telephone) to the safety data recorded in paper diaries. Immunogenicity: Primary: 1. To establish non-inferiority of the immune response of Rabies vaccine (administered concomitantly with JE vaccine) accelerated schedule as compared to conventional schedule. 2. To establish non-inferiority of the immune response of JE vaccine (administered concomitantly with Rabies vaccine), accelerated schedule as compared to conventional schedule. ;Secondary Objective: 1. Establish non-inferiority of the Rabies vaccine immune response (with JE vaccine) versus Rabies vaccine alone in a Conventional vaccination schedule. 2. Establish non-inferiority of the immune response of JE vaccine (with Rabies vaccine) versus JE vaccine alone in a Conventional vaccination schedule. 3. Establish non-inferiority of the immune response of Rabies vaccine (with JE vaccine) given in an Accelerated schedule versus Rabies vaccine alone in a Conventional vaccination schedule. 4. Establish non-inferiority of the immune response of JE vaccine (with Rabies vaccine) in an Accelerated schedule versus JE vaccine alone in a Conventional vaccination schedule. 5. Evaluate antibody response kinetics in groups receiving Rabies vaccine measured by rapid fluorescent focus inhibition test (RFFIT) 6. Evaluate antibody response kinetics in groups receiving JE vaccine. ;Primary end point(s): Percentage of subjects with RVNA titer = 0.5 IU/mL Percentage of subjects with PRNT50 titer = 1:10 Safety Endpoints: Solicited local and systemic reactions, adverse event collection (including SAE collection), and concomitant medication collection.;Timepoint(s) of evaluation of this end point: For RVNA titer: 7 days after the last active vaccine administration. For PRNT50 t

—

Secondary

Measure	Time frame
Secondary end point(s): • RVNA GMT • PRNT50 GMT ;Timepoint(s) of evaluation of this end point: RVNA GMT and PRNT50 GMT: 28 days after the last active vaccine administration.	—

Countries

Austria, Germany, Switzerland

Contacts

Public ContactRegulatory Affairs Senior Manager

Novartis Pharma BV

charmaine.augustinus-lever@novartis.com31205640516

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026