A Randomized, Open-label Study Comparing Two Different Rabies Vaccine Schedules in Chinese Children and Older Adults

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Vaccines )

ClinicalTrials.gov Identifier:

NCT01680016

First received: September 3, 2012

Last updated: January 14, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

September 3, 2012

Last Updated Date

January 14, 2013

Start Date ^ICMJE

September 2012

Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Geometric Mean Concentration of Rabies virus neutralizing antibody (RVNA)titers [ Time Frame: Day 14 after vaccination ] [ Designated as safety issue: No ]
Non inferiority of the (2-1-1) postexposure schedule to that of the conventional (1-1-1-1-1) postexposure schedule, as measured by GMC of RVNA titers 14 days after vaccination in children and older adults.
Local and systemic reactions [ Time Frame: 7 days after vaccination ] [ Designated as safety issue: Yes ]
AEs/SAEs [ Time Frame: 43 days ] [ Designated as safety issue: Yes ]
Safety and tolerability of the two schedules as measured by AEs/SAEs and solicited event reporting

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01680016 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

RVNA titers ≥ 0.5 IU/mL [ Time Frame: 14 days after first vaccination ] [ Designated as safety issue: No ]
Percentages of subjects with RVNA titer ≥ 0.5 IU/mL 14 days after the first vaccination.
GMC and percentage of subjects with RVNA titer ≥ 0.5 IU/mL [ Time Frame: 42 days after first vaccination ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Randomized, Open-label Study Comparing Two Different Rabies Vaccine Schedules in Chinese Children and Older Adults

Official Title ^ICMJE

A Phase IIIb, Randomized, Open-label Study Comparing Two Different Rabies Vaccine Postexposure Schedules (Zagreb 2-1-1 and Rabipur® Essen 1-1-1-1-1) in Chinese Children and Older Adults

Brief Summary

This study will explore the safety and immunogenicity of two simulated postexposure rabies vaccination schedules (Zagreb 2-1-1 and Essen 1-1-1-1-1) in Chinese children and older adults.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Rabies Disease

Intervention ^ICMJE

Biological: Rabies vaccine: Zagreb
4 doses: 2 doses given on Day 1, 1 dose given on Days 8 and 22
Biological: Rabies Vaccine: Essen
5 doses: 1 dose given on Days 1, 4, 8, 15 and 29

Study Arm (s)

Experimental: 1a
Children:

6 to 11 years and 12-17 years

Intervention: Biological: Rabies vaccine: Zagreb
Experimental: 1b
Adults:

51-60 years and more than 60 years

Intervention: Biological: Rabies vaccine: Zagreb
Active Comparator: 2a
Children:

6 to 11 years and 12-17 years

Intervention: Biological: Rabies Vaccine: Essen
Active Comparator: 2b
Adults:

51-60 years and more than 60 years

Intervention: Biological: Rabies Vaccine: Essen

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

640

Completion Date

January 2013

Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Individuals between 6-17 years of age and 51 years of age or older
Individuals who are in good health
Willingness to provide consent, comply with study procedures and duration of follow-up

Exclusion Criteria:

Contraindications to vaccination with rabies vaccine
Elevated body temperature
Known hypersensitivity to the components of the vaccine
Previously received any rabies vaccine or immune globulin
Previous or planned treatment with antimalarial medications
History of psychiatric disease, immune disorder, bleeding disorder, drug/alcohol abuse, malignancy
Female subjects who are pregnant or unwilling to practice acceptable birth control methods
Individuals enrolled or plans to enroll in another investigational trial

Gender

Both

Ages

6 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT01680016

Other Study ID Numbers ^ICMJE

V49_24

Has Data Monitoring Committee

Responsible Party

Novartis ( Novartis Vaccines )

Study Sponsor ^ICMJE

Novartis Vaccines

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Novartis Vaccines

Information Provided By

Novartis

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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