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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
  Purpose

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.


Condition Intervention Phase
Rabies Disease
 Biological: Rabies vaccine: Zagreb
Biological: Rabies Vaccine: Essen
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Rabies
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Enrollment: 640
Study Start Date: September 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1a

Children:

6 to 11 years and 12-17 years

 Biological: Rabies vaccine: Zagreb
4 doses: 2 doses given on Day 1, 1 dose given on Days 8 and 22
Experimental: 1b

Adults:

51-60 years and more than 60 years

 Biological: Rabies vaccine: Zagreb
4 doses: 2 doses given on Day 1, 1 dose given on Days 8 and 22
Active Comparator: 2a

Children:

6 to 11 years and 12-17 years

 Biological: Rabies Vaccine: Essen
5 doses: 1 dose given on Days 1, 4, 8, 15 and 29
Active Comparator: 2b

Adults:

51-60 years and more than 60 years

 Biological: Rabies Vaccine: Essen
5 doses: 1 dose given on Days 1, 4, 8, 15 and 29

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01680016

Locations
China, Guangxi
Guangxi Center for Disease Prevention and Control
Nanning, Guangxi, China, 530028
Sponsors and Collaborators
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines Novartis Vaccines
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01680016     History of Changes
Other Study ID Numbers: V49_24
Study First Received: September 3, 2012
Last Updated: January 14, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Novartis:
Rabies virus, postexposure, vaccine schedule, children, older adults

Additional relevant MeSH terms:
Rabies
Rhabdoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on May 19, 2013