NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Prevention of Swine-Origin Influenza A H1N1
Date of first enrollment	02/03/2010
Target sample size	100
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : Cell-derived A/H1N1 Influenza HA Vaccine INN of investigational material : Therapeutic category code : 631 Vaccines Dosage and Administration for Investigational material : Intramuscular injection

Outcome(s)

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

Key inclusion & exclusion criteria

Age minimum	>= 61age old
Age maximum	Not applicable
Gender	Both
Include criteria	Healthy Japanese aged over 60 years
Exclude criteria	-Any serious chronic or progressive disease according to judgment of the investigator (including, but not limited to neoplasm, insulin dependent diabetes, cardiac, renal, hepatic or respiratory disease) -History of any anaphylaxis, serious vaccine reactions, or hypersensitivity to influenza viral proteins, to any excipients -Administration of swine influenza (A/H1N1) vaccine prior to Day 1 or documented confirmed or suspected swine influenza disease -History of progressive or sever neurological disorders -Known or suspected impairment/alteration of immune function