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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00306995 | Safety Study of Pandemic Candidate Influenza Vaccines in the Elderly Population | PHASE2 | COMPLETED | 385 | — | — | May 11, 2005 | Jul 4, 2006 | Feb 10, 2020 | 10 | Germany |
Anti-H9N2 antibody titers were expressed as Geometric Mean Titers (GMTs).
Anti-H9N2 antibody titers were expressed as Geometric Mean Titers (GMTs).
Seroconversion rate was defined as the percentage of vaccinees who had a pre-vaccination HI titer lower than (\<) 1:10 and a post-vaccination titre higher than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four-fold increase in post-vaccination titer
Seroconversion factor was defined as the fold increase in serum HI GMTs on day 10 compared to day 0.
Seroprotection rate was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 after vaccination (for each vaccine strain) that usually was accepted as indicating protection.
Seroprotection power was defined as the proportion of subjects who were unprotected prior to the vaccination (HI titer \< 1:40 on day 0) and had a protective post-vaccination titer of ≥ 1:40.
| Arm | Type | Description |
|---|---|---|
| SB218352_15 Group | EXPERIMENTAL | Male and female subjects over 60 years of age, healthy or with underlying disease, received 2 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0 and Day 21. |
| SB218352_8 Group | EXPERIMENTAL | Male and female subjects over 60 years of age, healthy or with underlying disease, received 2 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0 and Day 21. |
| SB218352_4 Group | EXPERIMENTAL | Male and female subjects over 60 years of age, healthy or with underlying disease, received 2 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0 and Day 21. |
| SB218352_2 Group | EXPERIMENTAL | Male and female subjects over 60 years of age, healthy or with underlying disease, received 2 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0 and Day 21. |
| SB218352_8AL Group | EXPERIMENTAL | Male and female subjects over 60 years of age, healthy or with underlying disease, received 2 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0 and Day 21. |
| SB218352_4AL Group | EXPERIMENTAL | Male and female subjects over 60 years of age, healthy or with underlying disease, received 2 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0 and Day 21. |
| SB218352_2AL Group | EXPERIMENTAL | Male and female subjects over 60 years of age, healthy or with underlying disease, received 2 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0 and Day 21. |
| Name | Type | Description |
|---|---|---|
| SB218352_15 | BIOLOGICAL | Non-adjuvanted pandemic influenza A formulation 1 vaccine |
| SB218352_8 | BIOLOGICAL | Non-adjuvanted pandemic influenza A formulation 2 vaccine |
| SB218352_4 | BIOLOGICAL | Non-adjuvanted pandemic influenza A formulation 3 vaccine |
| SB218352_2 | BIOLOGICAL | Non-adjuvanted pandemic influenza A formulation 4 vaccine |
| SB218352_8AL | BIOLOGICAL | Pandemic influenza A formulation 2 aluminium-adjuvanted vaccine |
| SB218352_4AL | BIOLOGICAL | Pandemic influenza A formulation 3 aluminium-adjuvanted vaccine |
| SB218352_2AL | BIOLOGICAL | Pandemic influenza A formulation 4 aluminium-adjuvanted vaccine |
Inclusion criteria: * Subjects who the investigator believes that they can and will comply with the requirements of the protocol * A male or female aged over 60 years at the time of vaccination. * Written informed consent obtained from the subject. Exclusion criteria: * Use of any investigational...