NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	swine-origin Influenza A H1N1 Virus
Date of first enrollment	02/03/2010
Target sample size	120
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : Adjuvanted cell-derived, inactivated novel swine origin A/H1N1 monovalent subunit influenza virus vaccine INN of investigational material : Therapeutic category code : 631 Vaccines Dosage and Administration for Investigational material : intramuscular

Outcome(s)

Primary Outcome	Seroprotection, GMRs and Seroconversion rate at Weeks 0, 3 and 6
Secondary Outcome	AEs, vital signs, laboratory tests

Key inclusion & exclusion criteria

Age minimum	>=
Age maximum	<= 19age old
Gender	Both
Include criteria	Healthy Japanese aged 6 months to 19 years
Exclude criteria	- History of anaphylaxis, serious vaccine reactions, hypersensitivity to vaccine viral proteins or excipients - Administration of adjuvanted influenza vaccine or suspected influenza disease within 3 month prior to study start - Administration of any other vaccines within 4 weeks prior to enrollment expect for seasonal influenza vaccines within 1 week - History of progressive or severe neurological disorders