Phase II/III Study of the Safety and Effectiveness of HRIG With Active Rabies Vaccine in Healthy … (NCT02040090) | Clinical Trial Compass
CompletedPhase 2/3
Phase II/III Study of the Safety and Effectiveness of HRIG With Active Rabies Vaccine in Healthy Subjects
United States118 participantsStarted 2013-04
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Able and willing to sign an informed consent.
* Healthy male or female subjects of 18 - 75 years of age inclusive who have not previously been immunized against rabies.
* Ability to comply with completion of a home diary.
* No previous exposure to Rabies epidemic, Rabies vaccine and/or Rabies Immune globulin.
* No significant abnormalities in serum hematology, serum chemistry and serum immunogenic markers (C3, C4 and C50) according to the Principal Investigator's judgment.
* No significant abnormalities in urinalysis according to the Principal Investigator's judgment.
* No significant abnormalities in ECG per investigator judgment.
* Non-pregnant, non-lactating female subjects, whose screening pregnancy test is negative and who are using contraceptive methods deemed reliable by the investigator, or who are more than 5 years post-menopausal or surgically sterilized.
* Male subjects must be using at least one effective contraceptive method before study start and throughout the entire duration of the study.
Exclusion Criteria:
* History or laboratory evidence of immunoglobulin A deficiency.
* A history of previous administration of rabies vaccine or HRIG.
* History of live virus vaccine administration, e.g., measles vaccine, within the last 3 months.
* History of anaphylactic or anaphylactoid hypersensitivity reactions to chicken egg; history of mild allergic reactions to chicken egg, e.g., skin rash only, is not an exclusion criterion
* History of hyper…
What they're measuring
1
The Difference Between KamRAB and HRIG Comparator, in the Proportions of Subjects With Serum Anti-rabies IgG Antibody Concentration ≥ 0.5 IU/mL