Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
aTIV · 1 trial · 1 indication
Immunogenicity was assessed in terms of percentages of adult subjects ≥65 years of age with SRH areas ≥25mm2 against each of the three vaccine strains, three weeks after receiving one dose of aTIV. The related European Committee for Human Medicinal Products (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm2 is \>60%.
Immunogenicity was assessed in terms of percentages of adult subjects ≥65 years of age achieving seroconversion or significant increase in SRH area against each of the three vaccine strains, three weeks after receiving one dose of aTIV. 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\>30% of subjects achieve seroconversion or significant increase in post-vaccination SRH area.
The antibody responses following one dose of aTIV were evaluated in terms of geometric mean ratio GMRs of post vaccination GMAs to pre vaccination GMAs against each of the three vaccine strains, three weeks after receiving one dose of aTIV. The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is \> 2.0.
Immunogenicity was assessed in terms of percentages of adult subjects ≥65 years of age with HI titers ≥40, against each of the three vaccine strains, three weeks after receiving one dose of aTIV. The related European (CHMP) criterion for the assessment of immunogenicity is met if the of subjects achieving HI titers ≥ 40 is \>60%.
Immunogenicity was assessed in terms of percentages of adult subjects ≥65 years of age achieving seroconversion or significant increase in HI antibody titers after receiving one dose of aTIV. 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 \>30% of subjects achieve seroconversion or significant increase in post-vaccination HI titers.
The antibody responses following one dose of aTIV were evaluated in terms of GMRs of post vaccination geometric mean HI titers against each of the three vaccine strains, three weeks after receiving one dose of aTIV. The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is \> 2.0.
The number of adult subjects ≥65 years of age reporting solicited local and systemic adverse events and other solicited adverse events after receiving one dose of aTIV are reported.
The number of adult subjects ≥65 years of age subjects reporting any unsolicited adverse event (AEs) between Day 1 to 4 and serious adverse events (SAEs), medically attended AEs, AEs leading to withdrawal from the study between Day 1 to Day 22 after receiving one dose of aTIV are reported.
| Arm | Type | Description |
|---|---|---|
| aTIV | EXPERIMENTAL | Adult subjects ≥65 years of age received one dose of a trivalent, surface antigen, inactivated influenza vaccine including MF59C.1 adjuvant (aTIV), formulation 2013/2014 Northern Hemisphere |
| Name | Type | Description |
|---|---|---|
| aTIV | BIOLOGICAL | Adjuvanted Trivalent Influenza Virus Vaccine (surface antigen, inactivated, adjuvanted with MF59C.1, egg-derived) |
Inclusion Criteria: * Male or female volunteers aged 65 years or older, mentally competent, who gave written informed consent prior to study entry; * Were able to comply with all the study requirements; and * Were in good health as determined by the outcome of medical history, physical examination,...
aTIV is an investigational monoclonal antibody being studied for the prevention of Human Influenza. It is being developed by Novartis AG (NVS) and is currently in Phase 2 clinical development. The drug is intended for use in adults aged 65 years and older.
aTIV is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The drug is currently in Phase 2 clinical development for the prevention of Human Influenza.
aTIV is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for the prevention of Human Influenza in adults aged 65 years and older.
aTIV has been studied in one completed clinical trial, identified as NCT01879540. This Phase 2 trial evaluated the safety and immunogenicity of a subunit trivalent influenza vaccine in healthy adults aged 65 years and older. The trial was conducted in Belgium and enrolled 63 participants.
aTIV is an investigational monoclonal antibody being developed by Novartis AG (NVS) for the prevention of Human Influenza. It is currently in Phase 2 clinical development. The drug has been studied in a completed clinical trial involving healthy adults aged 65 years and older.