NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Prophylaxis of new type of influenza infection
Date of first enrollment	03/08/2012
Target sample size	600
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : KIB-PCI INN of investigational material : Therapeutic category code : 631 Vaccines Dosage and Administration for Investigational material : intramuscular

Outcome(s)

Primary Outcome	SRH antibody titer against H5 antigen
Secondary Outcome	HI antibody titer against H5 antigen Neutralizing antibody titer against H5N1 influenza virus

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	<= 64age old
Gender	Both
Include criteria	healthy adult Japanese volunteers
Exclude criteria	1)Subjects with history of H5N1 influenza 2)Subjects with history of H5N1 influenza vaccination