NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	preexposure prophylaxis against rabies
Date of first enrollment	16/07/2013
Target sample size	200
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : KD-357 INN of investigational material : Therapeutic category code : 631 Vaccines Dosage and Administration for Investigational material : Intramuscular administration of 1.0mL/dose on Days 0,7,and 28.(This is the standard pre-exposure schedule) control material(s) Generic name etc : Freeze-dried inactivated tissue culture rabies vaccine INN of investigational material : Therapeutic category code : 631 Vaccines Dosage and Administration for Investigational material : The subject receives a administration with 1.0mL (single dose) of the control drug twice with a four-week interval between doses via the subcutaneous route,and the subject receives an additional administration of 1.0mL six to twelve months later.

Outcome(s)

Primary Outcome	Rabies virus neutralizing antibody seropositive rate
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	<= 64age old
Gender	Both
Include criteria	(1)Subjects who are healthy Japanese between 20 and 65 inclusive at the time of obtaining informed consent. (2)Subjects who are able to give written informed consent.
Exclude criteria