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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01310413 | Monovalent H5N1 Vaccine GSK1557484A in Children 6 Months to < 18 Years of Age | PHASE3 | COMPLETED | 842 | — | — | Mar 7, 2011 | Jan 26, 2014 | Nov 1, 2021 | 17 | United States, Canada +1 |
| NCT00695669 | A Trial to Test the Response to Different Vaccination Regimens With an H5N1 Vaccine With AS03 in Adults Aged 18-64 | PHASE2 | COMPLETED | 312 | — | — | Jun 5, 2008 | Jan 8, 2009 | Jul 31, 2018 | 3 | Canada |
A seroprotected subject against the a/Indonesia/5/2005 (A/INDO) virus strain was defined as a subject with H5N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (\>=) the seroprotection cut-off of 1:40.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal hemagglutination inhibition (HI) titer less than (\<) 1:10 and a post-vaccination (at Day 14 post Dose 2) reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination (at Day 14 post Dose 2) titer.
Titers are presented as geometric mean titers (GMTs). The Confidence Interval for this outcome was 98.75%.
A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40.
| Arm | Type | Description |
|---|---|---|
| Influenza A (H5N1) adjuvanted 6-<36M Group | EXPERIMENTAL | Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm). |
| Influenza A (H5N1) Virus monovalent vaccine 3-<9Y Group | EXPERIMENTAL | Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm). |
| Influenza A (H5N1) Virus monovalent vaccine 9-<18Y Group | EXPERIMENTAL | Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm). |
| Placebo 6-<36M Group | PLACEBO_COMPARATOR | Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm). |
| Placebo 3-<9Y Group | PLACEBO_COMPARATOR | Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm). |
| Placebo 9-<18Y Group | PLACEBO_COMPARATOR | Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm). |
| Placebo/Influenza A (H5N1) adjuvanted Group | EXPERIMENTAL | Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-\<36M, Placebo 3-\<9Y or Placebo 9-\<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-\<36M, Placebo 3-\<9Y and Placebo 9-\<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 of was administered in the deltoid region of the non-dominant arm and Dose 2 in the deltoid region of the dominant arm. |
| Influenza A (H5N1) 1 Group | EXPERIMENTAL | Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm. |
| Influenza A (H5N1) 2 Group | EXPERIMENTAL | Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm. |
| Influenza A (H5N1) 3 Group | EXPERIMENTAL | Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm. |
| Influenza A (H5N1) 4 Group | EXPERIMENTAL | Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm. |
| Name | Type | Description |
|---|---|---|
| Influenza A (H5N1) Virus monovalent vaccine | BIOLOGICAL | All subjects will receive 2 doses administered as an intramuscular (IM) injection. |
| Saline placebo | BIOLOGICAL | All subjects will receive 2 doses administered as an intramuscular (IM) injection. |
Inclusion Criteria: * A male or female child \>= 6 months and \< 18 years of age at the time of first vaccination. * Written informed consent obtained from the subject's parent/guardian. * Documentation of assent for children 9 to \< 18 years of age (or as deemed mandatory by local practice). * Sat...