Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Influenza A Virus Monovalent Vaccine · 2 trials · 2 indications
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...
Influenza A Virus Monovalent Vaccine is an investigational vaccine being studied for the prevention of influenza. It is a monovalent vaccine designed to protect against a single strain of the influenza A virus. The vaccine is currently in Phase 3 clinical development.
Influenza A Virus Monovalent Vaccine is being developed by GSK plc, a biopharmaceutical company traded on the New York Stock Exchange under the ticker GSK. The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity in adult and pediatric populations.
Influenza A Virus Monovalent Vaccine is in Phase 3 clinical development. It has completed two clinical trials, including a Phase 2 study in adults and a Phase 3 study in children. The vaccine remains investigational and has not been approved by regulatory authorities.
Influenza A Virus Monovalent Vaccine has completed two clinical trials. NCT00695669 was a Phase 2 study testing different vaccination regimens with an H5N1 vaccine with AS03 in adults aged 18-64 in Canada. NCT01310413 was a Phase 3 study of the monovalent H5N1 vaccine in children aged 6 months to under 18 years in the United States, Canada, and Thailand.
Influenza A Virus Monovalent Vaccine is a monovalent H5N1 vaccine. Clinical trials for this vaccine have evaluated H5N1 influenza vaccine formulations, including regimens with the AS03 adjuvant. The vaccine is designed to target the H5N1 influenza A virus strain.