Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00964158 | Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (H1N1) (GSK2340272A) | PHASE3 | COMPLETED | 210 | — | — | Sep 10, 2009 | Nov 27, 2010 | Feb 19, 2018 | 5 | Spain |
| NCT00971321 | Safety, Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (H1N1) (GSK2340272A) | PHASE2 | COMPLETED | 157 | — | — | Sep 10, 2009 | Nov 24, 2010 | Feb 25, 2019 | 5 | Spain |
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...