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

September 3, 2012
January 14, 2013
September 2012
January 2013   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01680016 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Randomized, Open-label Study Comparing Two Different Rabies Vaccine Schedules in Chinese Children and Older Adults
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Rabies Disease
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
640
January 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
6 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01680016
V49_24
No
Novartis ( Novartis Vaccines )
Novartis Vaccines
Not Provided
Study Chair: Novartis Vaccines Novartis Vaccines
Novartis
January 2013

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