NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Prophylaxis of new type of influenza virus infection
Date of first enrollment	20/09/2012
Target sample size	800
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 control material(s) Generic name etc : egg-derived influenza A (H5N1) vaccine 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	1) Japanese healthy adult volunteers
Exclude criteria	1) Subjects with a history of influenza A (H5N1) virus infection 2) Subjects who have received influenza A (H5N1) vaccine