Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SB218352_15 · 1 trial · 2 indications
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...
SB218352_15 is a monoclonal antibody being developed for influenza, a viral infection of the respiratory tract. It is currently in Phase 2 clinical development as a potential treatment for this infectious disease.
SB218352_15 is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in influenza.
SB218352_15 is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved for commercial use. One Phase 2 trial has been completed, and the drug is not currently in any active trials.
SB218352_15 has been studied in one completed Phase 2 clinical trial, identified as NCT00306995. This trial, titled 'Safety Study of Pandemic Candidate Influenza Vaccines in the Elderly Population,' enrolled 385 participants aged 60 years and older in Germany.
SB218352_15 is a distinct investigational monoclonal antibody. No alternative names for this drug have been reported in the available clinical trial information.