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Pandemic influenza vaccine GSK2340272A · 2 trials · 1 indication
The seropositivity cut-off value of the assay was equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
The seropositivity cut-off value of the assay was ≥ 1:10 in the sera of subjects seronegative before vaccination. The flu strain assesssed was Flu A/CAL/7/09.
Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The flu strain assessed was Flu A/CAL/7/09.
A seroconverted subject was defined as: For initially seronegative subjects \[antibody titer below (\<) 1:10 prior to vaccination\], antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/CAL/7/09.
Seroprotection was defined as the percentage of subjects with a serum HI titer ≥ 1:40, that usually is accepted as indicating protection. The flu strain assessed was Flu A/CAL/7/09.
Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.
Seropositivity was defined as H1N1 HI antibody titers greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).
Antibody titers are presented as geometric mean titers (GMTs), with a reference seropositivity cut-off value greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).
Seroconversion (SCR) was defined as the percentage of vaccinees that have either a pre-vaccination titer \< 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The strain assessed was Flu A/California/7/2009 (H1N1).
Seroprotection (SPR) was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 that usually is accepted as indicating protection. The strain assessed was Flu A/California/7/2009 (H1N1).
Seroconversion factor was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The strain assessed was Flu A/California/7/2009 (H1N1).
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | - |
| GSK 2340272A F1 Group | EXPERIMENTAL | Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 1 (F1) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry. |
| GSK 2340272A F2 Group | EXPERIMENTAL | Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 2 (F2) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry. |
| Name | Type | Description |
|---|---|---|
| Pandemic influenza vaccine GSK2340272A | BIOLOGICAL | Two primary intramuscular (IM) injections and a booster IM injection |
Inclusion Criteria: * Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol. * Children, male or female, aged between 3 and 17 years at the time of the first study vaccination. * Written infor...
Pandemic influenza vaccine GSK2340272A is an investigational vaccine being developed for influenza, specifically as a pandemic influenza candidate vaccine against the H1N1 strain. It is designed to prevent disease caused by the pandemic influenza virus. The vaccine is currently in clinical development and is not yet approved for public use.
Pandemic influenza vaccine GSK2340272A is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. GSK is conducting clinical trials to evaluate the safety and immunogenicity of this pandemic influenza candidate vaccine.
Pandemic influenza vaccine GSK2340272A is in Phase 3 clinical development. It has completed two clinical trials, including a Phase 3 study and a Phase 2 study, both of which are finished. The vaccine remains investigational and has not received regulatory approval.
Pandemic influenza vaccine GSK2340272A has completed two clinical trials. NCT00964158 is a Phase 3 study in Spain with 210 participants aged 3 years and older, evaluating safety and immunogenicity. NCT00971321 is a Phase 2 study in Spain with 157 participants aged 6 months and older, also assessing safety and immunogenicity.
Yes, Pandemic influenza vaccine GSK2340272A is the same as GSK2340272A. The full name includes the vaccine's indication, while GSK2340272A is the shorter identifier used in clinical trial registries. Both names refer to the same pandemic influenza candidate vaccine developed by GSK.