drugset / Trial / NCT01079273
Clinical Study to Evaluate Antibody and Cell Mediated Immunity of A/H1N1 Influenza Vaccine in Healthy Subjects
NaSingle-groupOpen-label
Summary
The purpose of this study is explore the antibody and cell mediated immune responses to one injection of Focetria™ pandemic influenza vaccine in healthy adults aged 18-60 years.
Timeline
- Start
- 2009-12
- Primary completion
- 2010-11
- Completion
- 2010-11
Publications
- Results Faenzi E, Zedda L, Bardelli M, Spensieri F, Borgogni E, Volpini G, Buricchi F, Pasini FL, Capecchi PL, Montanaro F, Belli R, Lattanzi M, Piccirella S, Montomoli E, Ahmed SS, Rappuoli R, Del Giudice G, Finco O, Castellino F, Galli G. One dose of an MF59-adjuvanted pandemic A/H1N1 vaccine recruits pre-existing immune memory and induces the rapid rise of neutralizing antibodies. Vaccine. 2012 Jun 8;30(27):4086-94. doi: 10.1016/j.vaccine.2012.04.020. Epub 2012 Apr 19.
- Ahmed SS, Volkmuth W, Duca J, Corti L, Pallaoro M, Pezzicoli A, Karle A, Rigat F, Rappuoli R, Narasimhan V, Julkunen I, Vuorela A, Vaarala O, Nohynek H, Pasini FL, Montomoli E, Trombetta C, Adams CM, Rothbard J, Steinman L. Antibodies to influenza nucleoprotein cross-react with human hypocretin receptor 2. Sci Transl Med. 2015 Jul 1;7(294):294ra105. doi: 10.1126/scitranslmed.aab2354.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Focetria | Vaccine | 7.5 ug | Intramuscular |
| Comparator | Focetria | Vaccine | 0.5 ml | Intramuscular |
| Comparator | Focetria | Vaccine | 9.75 mg | Intramuscular |