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Post-marketing Study of KamRAB Administered as a Single Dose With Active Rabies Vaccine in Children Exposed to Rabies

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ClinicalTrials.gov Identifier: NCT02912845
Recruitment Status : Completed
First Posted : September 23, 2016
Last Update Posted : September 5, 2021
Sponsor:
Collaborator:
Kedrion S.p.A.
Information provided by (Responsible Party):
Kamada, Ltd.

Tracking Information
First Submitted Date  ICMJE September 18, 2016
First Posted Date  ICMJE September 23, 2016
Last Update Posted Date September 5, 2021
Actual Study Start Date  ICMJE August 1, 2016
Actual Primary Completion Date November 13, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2016)
  • Frequency and severity of local and systemic adverse events occurring within 14 days of KamRAB treatment [ Time Frame: Within 14 days from treatment ]
  • Frequency and severity of local and systemic SAEs occurring within 84 days of KamRAB treatment [ Time Frame: Within 84 days of treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Post-marketing Study of KamRAB Administered as a Single Dose With Active Rabies Vaccine in Children Exposed to Rabies
Official Title  ICMJE Post-marketing Study of KamRAB Administered as a Single Dose With Active Rabies Vaccine in Children Exposed to Rabies
Brief Summary The primary purpose of this study is to confirm the safety of KamRAB (Human Rabies Immunoglobulin) in children ages 0 months to <17 years, when administered as part of post-Rabies Exposure Prophylaxis (PEP).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rabies
Intervention  ICMJE Drug: KamRAB - HRIG
wound infiltration or IM injection
Study Arms  ICMJE Experimental: 20 IU/kg KamRAB + Active Anti-Rabies Vaccine
Intervention: Drug: KamRAB - HRIG
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
Actual Enrollment  ICMJE
 (submitted: September 22, 2016)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 13, 2019
Actual Primary Completion Date November 13, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy children (male and female) ages 0 months to <17 years.
  • Have been exposed or possibly exposed to rabies.
  • Are indicated to receive post-exposure prophylaxis (PEP) against rabies infection.
  • Have documented informed consent from the child's parent(s) or legal guardian(s) and assent from the child if appropriate.

Exclusion Criteria:

  • History of previous administration of rabies vaccine or human rabies immune globulin (HRIG)
  • Rabies exposure or possible rabies exposure more than seven days prior to initiation of PEP, or timing of exposure unknown
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02912845
Other Study ID Numbers  ICMJE KamRAB-004
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kamada, Ltd.
Study Sponsor  ICMJE Kamada, Ltd.
Collaborators  ICMJE Kedrion S.p.A.
Investigators  ICMJE Not Provided
PRS Account Kamada, Ltd.
Verification Date February 2019

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