Approval Probability
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Adjusted LOA
ML Risk
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...
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Pandemic influenza vaccine GSK2340272A is an investigational vaccine developed by GSK plc for protection against pandemic influenza, specifically the H1N1 strain. It is a vaccine candidate studied in healthy volunteers and is not an approved product. GSK lists it as being in Phase 3 development for influenza.
Pandemic influenza vaccine GSK2340272A is made by GSK plc, which trades under the ticker GSK. The vaccine is developed by GSK Biologicals, the company's vaccine division. GSK is the sole developer named for this pandemic influenza candidate.
Pandemic influenza vaccine GSK2340272A is in Phase 3 development. Its clinical program includes two completed trials, one Phase 2 and one Phase 3, with a combined enrollment of 367 participants. The vaccine remains investigational and is not an approved product.
Pandemic influenza vaccine GSK2340272A has been studied in two completed trials. NCT00971321 was a Phase 2 safety and immunogenicity study in 157 participants in Spain. NCT00964158 was a Phase 3 safety and immunogenicity study in 210 participants in Spain. Both trials enrolled healthy volunteers.
Pandemic influenza vaccine GSK2340272A is being developed for the prevention of pandemic influenza, specifically the H1N1 strain. It is intended for use in healthy volunteers, with trials enrolling participants from 6 months of age in the Phase 2 study and from 3 years of age in the Phase 3 study.
The two completed trials of Pandemic influenza vaccine GSK2340272A were randomized and controlled, evaluating safety and immunogenicity in healthy volunteers in Spain. The Phase 2 trial NCT00971321 enrolled 157 participants and the Phase 3 trial NCT00964158 enrolled 210 participants. Neither trial used a double-blind design.