Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01422512 | Safety and Immunogenicity of One Dose of a Surface, Antigen, Inactivated, Influenza Vaccine Produced in Mammalian Cell Culture Administered to Adult and Elderly Subjects | PHASE3 | COMPLETED | 126 | — | — | Sep 1, 2011 | Oct 1, 2011 | Oct 12, 2011 | 1 | Germany |
| NCT01357265 | Safety and Immunogenicity of One Dose of an Inactivated Trivalent Sub-unit Influenza Vaccine Administered to Non-elderly Adult and Elderly Subjects | PHASE2 | COMPLETED | 125 | — | — | May 1, 2011 | Jun 1, 2011 | Dec 7, 2011 | 6 | Italy |
| NCT00956449 | Safety and Immunogenicity of Influenza Vaccine (Surface Antigen, Inactivated) [Ph.Eur], Formulation 2009-2010, When Administered to Non-Elderly Adult and Elderly Subjects | PHASE2 | COMPLETED | 126 | — | — | Jun 1, 2009 | Jul 1, 2009 | Mar 28, 2017 | 1 | United Kingdom |
Antibody response to each influenza antigen as measured by hemagglutination inhibition (HI) at 21 days post-immunization in adult and elderly subjects in complinace with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines
To evaluate the antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) and/or HI at 21 days post-immunization in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines.
| Arm | Type | Description |
|---|---|---|
| cell culture derived TIV | EXPERIMENTAL | single dose of cell culture derived seasonal trivalent influenza vaccine (TIV) |
| 1 | OTHER | No comparator is administered, only one IM single dose of trivalent subunit inactivated influenza vaccine is administered during the vaccination visit |
| Name | Type | Description |
|---|---|---|
| seasonal influenza vaccine | BIOLOGICAL | Subjects received one single IM dose of trivalent Surface, Antigen, Inactivated, Influenza Vaccine Produced in Mammalian Cell Culture during the vaccination visit, according to the study protocol (follow-up period: until day 22) . |
Inclusion Criteria: 1. Males and female volunteers of 18 years of age or older, mentally competent, willing and able to give written informed consent prior to study entry 2. Individuals able to comply with all the study requirements 3. Individuals in good health as determined by the outcome of medi...