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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: April 22, 2014
Last verified: April 2014
Results First Received: January 7, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Rabies
Interventions: Biological: Zagreb
Biological: Essen

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were enrolled at Mengshan CDC

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All enrolled subjects were included in the trial

Reporting Groups
  Description
Zagreb(≥6 to ≤17 Years) ≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1, 8 and 22
Essen(≥6 to ≤17 Years) ≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
Zagreb(≥51 Years) ≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
Essen(≥51 Years) ≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29

Participant Flow:   Overall Study
    Zagreb(≥6 to ≤17 Years)     Essen(≥6 to ≤17 Years)     Zagreb(≥51 Years)     Essen(≥51 Years)  
STARTED     121     122     201     200  
COMPLETED     115     114     196     195  
NOT COMPLETED     6     8     5     5  
Adverse Event                 0                 0                 1                 4  
The Subject went out of The Trial                 1                 0                 3                 0  
Protocol Violation                 0                 1                 0                 0  
Withdrawal by Subject                 5                 7                 1                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Enrolled set:All subjects who had signed an informed consent, undergone screening procedure(s) and were randomized

Reporting Groups
  Description
Zagreb Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
Essen Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
Total Total of all reporting groups

Baseline Measures
    Zagreb     Essen     Total  
Number of Participants  
[units: participants]
  322     322     644  
Age  
[units: years]
Mean ± Standard Deviation
     
Children (≥6 to ≤17 Years)     11  ± 3.0     10.8  ± 2.9     10.9  ± 3.0  
Older Adults (≥51 Years)     62.1  ± 6.5     61.9  ± 6.8     62.0  ± 6.6  
Gender, Customized  
[units: Subjects]
     
Female (≥6 to ≤17 Years)     49     76     125  
Male (≥6 to ≤17 Years)     72     46     118  
Female (≥51 Years)     118     123     241  
Male (≥51 Years)     83     77     160  



  Outcome Measures
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1.  Primary:   Non-inferiority in Immune Response of the Zagreb Postexposure Schedule of Rabipur to That of the Conventional Essen Postexposure Schedule of Rabipur as Measured by GMC of RVNA Titer 14 Days After First Vaccination in Children Aged ≥6 to ≤17 Years.   [ Time Frame: Before vaccination (day 1) and 14 days after first vaccination (day 15) ]

2.  Primary:   Non-inferiority in Immune Response of the Zagreb Postexposure Schedule of Rabipur to That of the Conventional Essen Postexposure Schedule of Rabipur as Measured by GMC of RVNA Titer 14 Days After the First Vaccination in Older Adults Aged ≥51 Years   [ Time Frame: Before vaccination (day 1) and 14 days after first vaccination (day 15). ]

3.  Primary:   Number of Children Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur   [ Time Frame: Days 1 to 7 postvaccination ]

4.  Primary:   Number of Older Adults Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur   [ Time Frame: Days 1 to 7 postvaccination ]

5.  Primary:   Number of Children Who Reported Unsolicited Adverse Events (AEs)   [ Time Frame: From V1/day 1 (postvaccination) through V7/study termination day 43 ]

6.  Primary:   Number of Older Adults Who Reported Unsolicited Adverse Events (AEs)   [ Time Frame: from V1/day 1 (postvaccination) through V7/study termination day 43 ]

7.  Secondary:   Percentages of Children With RVNA Titers ≥0.5 IU/mL 14 Days After First Vaccination of Rabipur   [ Time Frame: Before vaccination (day 1) and 14 days after first vaccination (day 15). ]

8.  Secondary:   Percentages of Older Adults With RVNA Titers ≥0.5 IU/mL 14 Days After First Vaccination of Rabipur   [ Time Frame: Before vaccination (day 1) and 14 days after first vaccination (day 15). ]

9.  Secondary:   Percentages of Children With RVNA Titers ≥0.5 IU/mL 42 Days After First Vaccination of Rabipur   [ Time Frame: Before vaccination (day 1) and 42 days after first vaccination (day 43). ]

10.  Secondary:   Percentages of Older Adults With RVNA Titers ≥0.5 IU/mL 42 Days After First Vaccination of Rabipur   [ Time Frame: Before vaccination (day 1) and 42 days after first vaccination (day 43). ]

11.  Secondary:   GMCs of RVNA Titer 42 Days After First Vaccination in Children.   [ Time Frame: Before vaccination (day 1) and 42 days after first vaccination (day 43) ]

12.  Secondary:   GMCs of RVNA Titer 42 Days After the First Vaccination in Older Adults.   [ Time Frame: Before vaccination (day 1) and 42 days after first vaccination (day 43) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Posting Director
Organization: Novartis Vaccines and Diagnostics
e-mail: RegistryContactVaccinesUS@novartis.com


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
Results First Received: January 7, 2014
Last Updated: April 22, 2014
Health Authority: China: Food and Drug Administration