NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Prophylaxis of influenza infection
Date of first enrollment	23/06/2014
Target sample size	50
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : VN-0104(Seasonal influenza quadrivalent vaccine) INN of investigational material : Therapeutic category code : 631 Vaccines Dosage and Administration for Investigational material : Subcutaneous

Outcome(s)

Primary Outcome	Safety endpoints: adverse events, body temperature Immunology endpoints: HI antibody titer, SRH antibody titer, Neutralizing antibody titer
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	<= 65age old
Gender	Both
Include criteria	Japanese healthy adult volunteers
Exclude criteria	1) Subjects with history of seasonal influenza in the past 6 months 2) Subjects with history of seasonal influenza vaccination in the past 6 months