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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01196988 | Immunogenicity and Safety Study of GSK Biologicals' Influenza Vaccine When Administered in Children | PHASE3 | COMPLETED | 3,027 | — | — | Oct 4, 2010 | Jun 15, 2011 | Sep 21, 2018 | 59 | United States, Czechia +3 |
| NCT01204671 | Safety and Immunogenicity Study of GSK Biologicals' Seasonal Influenza Candidate Vaccine (GSK2321138A) | PHASE3 | COMPLETED | 4,659 | — | — | Oct 4, 2010 | Jun 6, 2011 | Sep 24, 2018 | 42 | United States, Germany +4 |
| NCT00985790 | Immunogenicity and Safety Study of a GlaxoSmithKline Biologicals' Candidate Influenza Vaccine in Healthy Children | PHASE2 | COMPLETED | 599 | — | — | Oct 8, 2009 | May 21, 2010 | Sep 21, 2018 | 2 | Mexico |
Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).
A seroconverted subject was defined as a vaccinated subject who had 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 four-fold increase in post-vaccination titer. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).
Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. HI antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.
A seroconverted subject was a vaccinated subject who had either a pre-vaccination hemagglutination inhibition (HI) antibody titer \< 1:10 and a post-vaccination titer above or equal (\>=) 1:40, or a pre-vaccination HI antibody titer \>= 1:10 and at least a 4-fold increase in post-vaccination HI antibody titer. Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.
Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 3 influenza strains assessed were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2) and Flu B/Brisbane/60/08 Victoria (VICT).The POST results were the primary outcome variables.
| Arm | Type | Description |
|---|---|---|
| GSK2321138A 1 Group | EXPERIMENTAL | Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28. |
| Fluarix Group | ACTIVE_COMPARATOR | Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28. |
| GSK2604409A Group | ACTIVE_COMPARATOR | Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28. |
| GSK2321138A 2 Group | EXPERIMENTAL | Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28. |
| GSK2321138A Lot 1 Group | EXPERIMENTAL | Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. |
| GSK2321138A Lot 2 Group | EXPERIMENTAL | Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. |
| GSK2321138A Lot 3 Group | EXPERIMENTAL | Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. |
| GSK2321138A Group | EXPERIMENTAL | Subjects aged between 18 and 47 months received the GSK2321138A. "Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm. |
| Name | Type | Description |
|---|---|---|
| Influenza vaccine GSK2321138A | BIOLOGICAL | intramuscular injections |
| FluarixTM | BIOLOGICAL | intramuscular injections |
| Influenza vaccine GSK2604409A | BIOLOGICAL | intramuscular injections |
| Fluarix™ | BIOLOGICAL | Intramuscular 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. * For non US countries: * \- Children, male or female, aged between 6 months and 17 years at the time of the first ...