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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02427750 | A Study to Evaluate Safety and Immunogenicity of Trivalent Influenza Vaccine, Formulation 2015 Southern Hemisphere, When Administered to Healthy Adult Subjects. | PHASE2 | COMPLETED | 126 | — | — | Apr 1, 2015 | May 1, 2015 | Oct 19, 2015 | 1 | Brazil |
Immunogenicity was assessed in terms of percentages of subjects in both age groups with SRH areas ≥25mm\^2 against each of the three vaccine strains, three weeks after receiving one dose of TIV. The related European Committee for Medicinal Products for Human Use (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm\^2 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 TIV. Seroconversion is defined as percentage of subjects with a pre vaccination SRH area ≤ 4mm\^2 achieving a post vaccination SRH area ≥ 25mm\^2. Significant increase is defined as percentage of subjects with a pre-vaccination SRH area \> 4mm\^2 achieving at least 50% increase in post vaccination SRH area. 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 SRH areas.
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 TIV. 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 in 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 TIV. 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 TIV. Seroconversion is defined as percentage of subjects with a pre vaccination HI titer \<10 and a post vaccination titer ≥40. Significant increase is defined as percentage of subjects with a pre vaccination HI titer ≥10 and 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 vaccination of TIV 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 TIV. 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 TIV are reported.
The number of subjects in both age groups reporting any unsolicited AEs between Day 1 to Day 4 after receiving one dose of TIV.
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 (Day 1 to Day 22), after receiving one vaccination of TIV is reported.
| Arm | Type | Description |
|---|---|---|
| Trivalent Influenza Vaccine | EXPERIMENTAL | One injection of Agrippal® |
| Name | Type | Description |
|---|---|---|
| Aggripal® | BIOLOGICAL | TIV |
Inclusion Criteria: 1. Individuals of 18 years of age and above on the day of informed consent. 2. Individuals who have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry. 3. Individuals who ca...