drugset / Trial / NCT00989612
Study to Evaluate Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1)
NaSingle-groupOpen-labelPrevention
Summary
This trial will assess the immunogenicity and safety elicited by the adjuvanted GSK Biologicals' influenza investigational vaccine GSK2340274A in healthy Japanese adults aged 20-64 years.
Timeline
- Start
- 2009-10-01
- Primary completion
- 2010-04-19
- Completion
- 2010-04-19
Publications
- Ikematsu H, Nagai H, Kawashima M, Kawakami Y, Tenjinbaru K, Li P, Walravens K, Gillard P, Roman F. Characterization and long-term persistence of immune response following two doses of an AS03A-adjuvanted H1N1 influenza vaccine in healthy Japanese adults. Hum Vaccin Immunother. 2012 Feb;8(2):260-6. doi: 10.4161/hv.18469. Epub 2012 Feb 1.
- Ikematsu H, Nagai H, Kawashima M, Kawakami Y, Tenjinbaru K, Maeda A, Li P, Gillard P, Roman F. Immunogenicity and safety of a novel AS03(A)-adjuvanted H1N1 2009 pandemic influenza vaccine in adults in Japan. Hum Vaccin. 2010 Nov;6(11):888-93. doi: 10.4161/hv.6.11.12851. Epub 2010 Nov 1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GSK2340274A | Vaccine | 3.75 ug | Intramuscular |