Safety and Immunogenicity of Two Intradermal Rabies Vaccine Regimens Administered With and Without Human Rabies Immunoglobulin in Subjects ≥ 1 Years of Age

Phase 3 Completed 885 enrolled Novartis Novartis Vaccines · collab

RandomizedParallel-groupOpen-labelPrevention

Summary

Demonstrate non-inferiority of the immune response between new versus the currently recommended intradermal regimens of rabies vaccine when administered with or without rabies immunoglobulins in healthy subjects ≥ 1 years of age.

Timeline

Start: 2014-06
Primary completion: 2014-10
Completion: 2015-08

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Human Rabies Immunoglobulin	Protein / enzyme biologic	20 iu/kg	Intramuscular
Comparator	Rabies vaccine	Vaccine	0.1 ml	Other

Safety and Immunogenicity of Two Intradermal Rabies Vaccine Regimens Administered With and Without Human Rabies Immunoglobulin in Subjects ≥ 1 Years of Age

Summary

Timeline

Drugs

Indications