Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pandemrix · 1 trial · 1 indication
A seroconverted subject is a subject who had either a pre-vaccination reciprocal hemagglutination inhibition (HI) titer \< 10 and a postvaccination reciprocal titer \>= 40, or a pre-vaccination reciprocal HI titer \>= 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.
A seroprotected subject was a subject with reciprocal HI titers \>= 40 against the vaccine homologous virus. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.
The GMFR is defined as the Geometric Mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.
| Arm | Type | Description |
|---|---|---|
| Pandemrix+Fluarix and Pandemrix+Placebo | EXPERIMENTAL | Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm. |
| Pandemrix+Placebo and Pandemrix+Fluarix | EXPERIMENTAL | Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm. |
| Name | Type | Description |
|---|---|---|
| Pandemrix (Influenza vaccine GSK2340272A) | BIOLOGICAL | Intramuscular injection, 2 doses |
| Fluarix™ | BIOLOGICAL | Intramuscular injection, 1 dose |
| Placebo | BIOLOGICAL | Intramuscular injection, 1 dose |
Inclusion Criteria: * Male or female subjects 61 years of age or older at the time of the first vaccination * Subjects who the investigator believes that they can and will comply with the requirements of the protocol. * Written informed consent obtained from the subject. * Satisfactory baseline med...
Pandemrix is an investigational vaccine being studied for influenza. It is a monoclonal antibody modality developed by GSK plc. The drug is currently in Phase 2 clinical development, and it is not approved for use. It is being evaluated for its immunogenicity and safety in elderly populations.
Pandemrix is developed by GSK plc, a biopharmaceutical company listed on the stock exchange under the ticker GSK. The drug is currently in Phase 2 clinical development for influenza. GSK is conducting clinical trials to evaluate the vaccine's safety and immunogenicity.
Pandemrix is in Phase 2 clinical development. It is an investigational vaccine for influenza and has not been approved by regulatory authorities. The drug is being studied in a completed Phase 2 trial to assess its immunogenicity and safety in elderly subjects.
Pandemrix has one completed clinical trial, NCT00968890, titled 'Immunogenicity and Safety of Vaccine GSK2340272A (H1N1) and GSK Biologicals Fluarix™ Vaccine When Co-administered in Elderly.' This Phase 2 trial enrolled 168 participants in Sweden, with healthy volunteers aged 61 years and older.
Pandemrix is also known as GSK2340272A. In clinical trial NCT00968890, the vaccine is referred to as GSK2340272A (H1N1). This alternative name is used in the study title and may appear in scientific literature and regulatory documents.