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Also known as Pandemrix (Influenza vaccine GSK2340272A)
Pandemrix · 2 trials · 1 indication
Titers were expressed as GMTs. The Pandemrix vaccine strain was A/Cal/7/09.
The Pandemrix vaccine strain was A/Cal/7/09. The cut-off was a titer of 1:10 and this titer was considered as seropositivity.
The Pandemrix vaccine strain was A/Cal/7/09. A subject seroconverted for haemagglutination inhibition (HI) antibodies was defined as a subject with either a prevaccination (Day 0) HI antibody titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a prevaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.
Seroconversion Factor (SCF) is defined as the fold increase in serum HI antibody GMTs post-vaccination compared to prevaccination (Day 0). The Pandemrix vaccine strain was A/Cal/7/09.
The Pandemrix vaccine strain was A/Cal/7/09. A seroprotected subject was defined as a subject with a serum HI antibody titer greater than or equal to 1:40.
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 |
|---|---|---|
| Placebo-Pandemrix-Fluarix Group | EXPERIMENTAL | Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42. |
| Fluarix-Pandemrix-Placebo Group | EXPERIMENTAL | Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42. |
| 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 (GSK investigational influenza GSK2340272A vaccine) | BIOLOGICAL | 2 doses intramuscular injections |
| Fluarix™ | BIOLOGICAL | 1 dose intramuscular injection |
| Placebo | BIOLOGICAL | 1 dose intramuscular injection |
| Pandemrix (Influenza vaccine GSK2340272A) | BIOLOGICAL | Intramuscular injection, 2 doses |
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 me...
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Pandemrix is an influenza vaccine developed for protection against pandemic influenza, specifically the H1N1 strain. It is a vaccine candidate studied in elderly adults aged 61 years and older. Its clinical program evaluated immune response and safety in this older population.
Pandemrix is developed by GSK plc, which trades under the ticker GSK. The vaccine is also referenced in company materials as GSK2340272A, reflecting its internal development code at GSK.
Pandemrix has been studied in Phase 3 clinical development. Its Phase 3 trial, NCT00971425, was completed, and a Phase 2 trial, NCT00968890, was also completed. It is an investigational vaccine candidate rather than a marketed product based on the available development record.
Pandemrix has been evaluated in two completed clinical trials. NCT00971425 was a Phase 3 study of a pandemic influenza H1N1 candidate vaccine conducted in Germany with 145 participants. NCT00968890 was a Phase 2 immunogenicity and safety study of GSK2340272A co-administered with Fluarix in Sweden with 168 participants.
Yes, Pandemrix is also known as GSK2340272A, and the full development name is Pandemrix (Influenza vaccine GSK2340272A). Other recorded names include Pandemrix (GSK investigational influenza GSK2340272A vaccine). These names refer to the same GSK pandemic influenza vaccine asset.
Pandemrix was studied in elderly adults, with both completed trials enrolling participants aged 61 years and older. The trials were randomized, double-blind, and controlled, and enrolled healthy volunteers. Total enrollment across the two studies was 313 participants, conducted in Germany and Sweden.