UMIN ID: C000000241
Registered date:22/09/2005
Research on influenza vaccine immunogencity in infants.
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | influenza |
| Date of first enrollment | 2005/10/01 |
| Target sample size | 200 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Influenza HA vaccine is inoculated twice at 4 weeks interval. Side reaction survey at 48hours after vaccination and survey during epidemics of influenza are conducted. Inoculated dose: 0.1 mL for infants <1 year of age. 0.2mL for infants 1-3years of age. |
Outcome(s)
| Primary Outcome | HI titers before and after vaccination. |
|---|---|
| Secondary Outcome | Survey on side reaction after vaccination. Survey during epidemics of influenza. |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| Age maximum | 4years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1.Infants with a fever at the time of planned vaccination. 2.Infants with serious acute diseases. 3.Infants who has induced anaphylaxis by the substances of the vaccine. 4.Infants considered inappropriate to be inoculated vaccine. |
Related Information
| Primary Sponsor | The Research Foundation for Microbial Diseases of Osaka University |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Health and Labour Sciences Research Grants |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Shin Irie |
| Address | Japan |
| Telephone | 092-733-1001 |
| Affiliation | Medical Co. LTA Kyusyu Clinical Pharmacology Research Clinic Clinical Pharmacology Department |
| scientific contact | |
| Name | Shin Irie |
| Address | 2-13-16 Jigyo Chuo-ku, Fukuoka Japan |
| Telephone | 092-733-1001 |
| Affiliation | Medical Co. LTA Kyusyu Clinical Pharmacology Research Clinic Clinical Pharmacology Department |