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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01885117 | Safety and Immunogenicity of One Dose of Seasonal Trivalent Influenza Virus Vaccine (TIVf, Purified Surface Antigen, Inactivated, Egg Derived) in Adults, Aged 18 Years and Above | PHASE3 | COMPLETED | 125 | — | — | Aug 1, 2013 | Sep 1, 2013 | Mar 12, 2014 | 1 | Germany |
Immunogenicity was assessed in terms of percentages of subjects in both age groups with SRH areas ≥25mm2 against each of the three vaccine strains, three weeks after receiving one dose of TIVf. The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm2 is \>70% for adults aged 18 to ≤60 years and \>60% for subjects aged ≥61 years.
Immunogenicity was assessed in terms of percentages of subjects in both age groups achieving seroconversion or significant increase by SRH area against each of the three vaccine strains ,three weeks after receiving one dose of TIVf. Seroconversion is defined as percentage of subjects with a pre vaccination SRH area ≤4mm2 achieving a post vaccination SRH area ≥25 mm2. Significant increase is defined as percentage of subjects with a pre vaccination SRH area \>4mm2 achieving at least 50% increase in post vaccination SRH area. The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm2 is \>40% for adults aged 18 to ≤60 years and \>30% for subjects aged ≥61 years.
The antibody responses were evaluated in terms of GMRs of post vaccination GMAs to pre vaccination GMAs against each of the three vaccine strains, three weeks after receiving one dose of TIVf. The related European Committee for Human Medicinal Products (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is \>2.5 for adults aged 18 to ≤60 years and \> 2.0 for subjects aged ≥61 years.
Immunogenicity was assessed in terms of percentages of subjects in both age groups with HI titers ≥40, against each of the three vaccine strains, three weeks after receiving one dose of TIVf. The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving HI titers ≥ 40 is \>70% for adults aged 18 to ≤60 years and \>60% for subjects aged ≥61 years.
Immunogenicity was assessed in terms of percentages of subjects in both age groups achieving seroconversion or significant increase in HI antibody titers after receiving one dose of TIVf. Seroconversion is defined as percentage of subjects with a pre vaccination HI titer \<10 to a post vaccination titer ≥40. Significant increase is defined as percentage of subjects with a pre vaccination HI titer ≥10 to at least a 4-fold increase in post vaccination HI antibody titers. The related European (CHMP) criterion for the assessment of immunogenicity is met if\>40 % for adults aged 18 to ≤60 years and\>30% for subjects aged ≥61 years achieve seroconversion or significant increase in post vaccination HI titers.
The antibody responses following one dose of TIVf were evaluated in terms of GMRs of post vaccination against pre vaccination geometric mean HI titers against each of the three vaccine strains, three weeks after receiving one dose of TIVf. The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is \>2.5 for adults aged 18 to ≤60 years and \> 2.0 for subjects aged ≥61 years.
The number of adult and elderly subjects reporting solicited local and systemic AEs and other solicited AEs after receiving one dose of TIVf are reported.
The number of subjects in both age groups reporting any unsolicited AEs (between Day 1 to 4), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal (throughout the study period), after receiving one dose of TIVf is reported.
| Arm | Type | Description |
|---|---|---|
| TIVf (18 to ≤ 60 years) | EXPERIMENTAL | Adult subjects aged 18 to ≤ 60 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere |
| TIVf (≥ 61 years) | EXPERIMENTAL | Adult subjects aged ≥ 61 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere |
| Name | Type | Description |
|---|---|---|
| TIVf | BIOLOGICAL | Trivalent Influenza Virus Vaccine (purified surface antigen, inactivated, egg-derived) |
Inclusion Criteria: * Male or female volunteer aged 18 years or older, mentally competent, who gave written informed consent prior to study entry; * Able to comply with all the study requirements; and * In good health as determined by the outcome of medical history, physical examination, and clinic...