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

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

Tracking Information

• First Submitted Date: September 18, 2016
• First Posted Date: September 23, 2016
• Last Update Posted Date: September 5, 2021
• Actual Study Start Date: August 1, 2016
• Actual Primary Completion Date: November 13, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Post-marketing Study of KamRAB Administered as a Single Dose With Active Rabies Vaccine in Children Exposed to Rabies
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Rabies

Intervention

Drug: KamRAB - HRIG

wound infiltration or IM injection

Study Arms

Experimental: 20 IU/kg KamRAB + Active Anti-Rabies Vaccine

Intervention: Drug: KamRAB - HRIG

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 22, 2016): 30
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: November 13, 2019
• Actual Primary Completion Date: November 13, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 0 Years to 17 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02912845
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: Kamada, Ltd.
• Original Responsible Party: Same as current
• Current Study Sponsor: Kamada, Ltd.
• Original Study Sponsor: Same as current
• Collaborators: Kedrion S.p.A.
• Investigators: Not Provided
• PRS Account: Kamada, Ltd.
• Verification Date: February 2019