CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 118 enrolled
Drug / intervention
Active rabies vaccine (US-FDA approved)drug
Likely dose
Active rabies vaccine (US-FDA approved) 1.0 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02040090
NCT02040090Phase 3Completed
CompareCT.gov

A Prospective, Randomized, Double-Blind, Non Inferiority, Phase II/III Study of the Safety and Efficacy of Simulated Post-Exposure Prophylaxis With Kamada Human Rabies Immune Globulin (KamRAB) and Active Rabies Vaccine in Healthy Subjects

Kamada, Ltd.·interventional·Posted Jan 20, 2014·Updated Sep 29, 2021

In Brief

A Phase 3 clinical trial evaluating Active rabies vaccine (US-FDA approved) for Rabies. Completed, enrolled 118 participants across 1 site.

Detailed Summary

The purpose of this study is to: 1. Evaluate the safety and tolerability of KamRAB in comparison with Human rabies immune globulin (HRIG) comparator product. 2. To assess whether KamRAB interferes with the development of self active antibodies when given simultaneously with active rabies vaccine, as compared to the HRIG comparator product, also given in conjunction with the active rabies vaccine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRabies
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 20, 2014
Enrollment StartApr 1, 2013
Primary CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 12.5 years ago

Interventions

Active rabies vaccine (US-FDA approved)drug

A 1.0 ml dose of active vaccine (2.5 IU/ml), will be given on 5 occasions, on Days 0, 3, 7, 14, and 28 On day 0, the day when the HRIG is given, the first vaccine dose could be given within few minutes from the time of HRIG injection was given and never be administered into the same anatomical site as the HRIG.