Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Adjuvanted H5N1 pandemic influenza vaccine · 3 trials · 1 indication
The optimal aH5N1c vaccine formulation was evaluated in terms of percentages of subjects achieving HI titers ≥40 against homologous A/H5N1 strain, three weeks after second vaccination with either low dose or high dose of aH5N1c vaccine, according to the Center for Biologics Evaluation and Research (CBER) criterion. The CBER criterion for the elderly population is met if the lower limit of the two-sided 95% confidence interval (CI) for the percentages of subjects achieving HI titer ≥40 meets or exceeds 60%.
Immunogenicity was measured in terms of the percentages of subjects achieving seroconversion or significant increase in HI titer against the vaccine strain, three weeks after receiving two injections of low dose or high dose of aH5N1c vaccine according to the CBER criterion. Seroconversion is defined as, a postvaccination titer ≥40 in subjects with a prevaccination HI titer \<10; or in subjects with prevaccination HI titer ≥10, a minimum four-fold rise in postvaccination HI antibody titer. The CBER criterion for the elderly population is met if the lower limit of the two-sided 95% CI for the percentages of subjects achieving seroconversion for HI antibody titer meets or exceeds 30%.
Safety was assessed as the number of subjects who reported solicited local and systemic adverse events following vaccination with either low or high dose of aH5N1c vaccine.
Safety was assessed using the number of subjects who reported any unsolicited adverse events, adverse events possibly or probably related to study vaccine, serious adverse events (SAEs), new onset of chronic diseases (NOCDs), medically attended AEs, AEs of special interest (AESIs), AEs leading to withdrawal from study following vaccination with aH5N1c vaccine
The optimal aH5N1c vaccine formulation was evaluated in terms of percentages of subjects achieving HI titers ≥40 against homologous A/H5N1 strain, three weeks after second vaccination with either low dose or high dose of aH5N1c vaccine, according to the Center for Biologics Evaluation and Research (CBER) criterion. CBER criterion for the adult population is met if the lower limit of the two-sided 95% confidence interval (CI) for the percentages of subjects achieving HI titer ≥40 meets or exceeds 70%.
Immunogenicity was measured in terms of the percentages of subjects achieving seroconversion or significant increase in HI titer against the vaccine strain, three weeks after receiving two injections of low dose or high dose of aH5N1c vaccine according to the CBER criterion. Seroconversion is defined as either a) in subjects with a prevaccination HI titer \<10, a postvaccination titer ≥40; or b) in subjects with prevaccination HI titer ≥10, a minimum four-fold rise in postvaccination HI antibody titer. CBER criterion for the adult population is met if the lower limit of the two-sided 95% CI for the percentages of subjects achieving seroconversion for HI antibody titer meets or exceeds 40%.
Safety was assessed using the number of subjects who reported solicited local and systemic AEs following vaccination with either low or high dose of aH5N1c vaccine.
Safety was assessed using the number of subjects who reported any unsolicited adverse events, adverse events possibly or probably related to study vaccine, serious adverse events (SAEs), new onset of chronic diseases (NOCDs), medically attended AEs, AEs of special interest (AESIs), AEs leading to withdrawal from study following vaccination with either low or high dose of aH5N1c vaccine.
The optimal aH5N1c vaccine formulation was evaluated in terms of percentages of subjects aged 6 to \<36 months, achieving HI titers ≥40 against homologous A/H5N1 strain, three weeks after second vaccination with either low dose or high dose of aH5N1c vaccine, according to the Center for Biologics Evaluation and Research (CBER) criterion. As there is no CBER criteria defined for children, immunogenicity was evaluated using CBER criterion applicable for adults (18-64 years). CBER criterion is met if the lower limit of the two-sided 95% confidence interval (CI) for the percentages of subjects achieving HI titer ≥40 meets or exceeds 70%.
The optimal aH5N1c vaccine formulation was evaluated in terms of percentages of subjects aged 3 to \<9 years, achieving HI titers ≥40 against homologous A/H5N1 strain, three weeks after second vaccination with either low dose or high dose of aH5N1c vaccine, according to the CBER criterion. As there is no CBER criteria defined for children, immunogenicity was evaluated using CBER criterion applicable for adults (18-64 years). CBER criterion is met if the lower limit of the two-sided 95% CI for the percentages of subjects achieving HI titer ≥40 meets or exceeds 70%.
The optimal aH5N1c vaccine formulation was evaluated in terms of percentages of subjects aged 9 to \<18 years, achieving HI titers ≥40 against homologous A/H5N1 strain, three weeks after second vaccination with either low dose or high dose of aH5N1c vaccine, according to the CBER criterion. As there is no CBER criteria defined for children, immunogenicity was evaluated using CBER criterion applicable for adults (18-64 years). CBER criterion is met if the lower limit of the two-sided 95% CI for the percentages of subjects achieving HI titer ≥40 meets or exceeds 70%.
Immunogenicity was measured in terms of the percentages of subjects aged 6 to \<36 months, achieving seroconversion or significant increase in HI titer against the vaccine strain, three weeks after receiving two injections of low dose or high dose of aH5N1c vaccine according to the CBER criteria. Seroconversion is defined as the percentages of subjects with a prevaccination HI titer \<10, a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, and a minimum four-fold rise in postvaccination HI antibody titer. CBER criterion is met if the lower limit of the two-sided 95% CI for the percentages of subjects achieving seroconversion for HI antibody titer meets or exceeds 40%.
Immunogenicity was measured in terms of the percentages of subjects aged 3 to \<9 years, achieving seroconversion or significant increase in HI titer against the vaccine strain, three weeks after receiving two injections of low dose or high dose of aH5N1c vaccine according to the CBER criteria. Seroconversion is defined as the percentages of subjects with a prevaccination HI titer \<10, a postvaccination titer ≥40; or subjects with prevaccination HI titer ≥10, and a minimum four-fold rise in postvaccination HI antibody titer. CBER criterion is met if the lower limit of the two-sided 95% CI for the percentages of subjects achieving seroconversion for HI antibody titer meets or exceeds 40%.
Immunogenicity was measured in terms of the percentages of subjects aged 9 to \<18 years, achieving seroconversion or significant increase in HI titer against the vaccine strain, three weeks after receiving two injections of low dose or high dose of aH5N1c vaccine according to the CBER criteria. Seroconversion is defined as the percentages of subjects with a prevaccination HI titer \<10, a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, and a minimum four-fold rise in postvaccination HI antibody titer. CBER criterion is met if the lower limit of the two-sided 95% CI for the percentages of subjects achieving seroconversion for HI antibody titer meets or exceeds 40%.
Safety was assessed using the number of subjects who reported solicited local and systemic adverse events following vaccination with either low or high dose of aH5N1c vaccine.
Safety was assessed using the number of subjects who reported solicited local and systemic adverse events following vaccination with either low or high dose of aH5N1c vaccine.
Safety was assessed using the number of subjects who reported any unsolicited adverse events, adverse events possibly or probably related to study vaccine, serious adverse events (SAEs), new onset of chronic diseases (NOCDs), medically attended AEs, AEs of special interest (AESIs), AEs leading to withdrawal from study following vaccination with either low or high dose of aH5N1c vaccine.
| Arm | Type | Description |
|---|---|---|
| aH5N1c - High dose | EXPERIMENTAL | - |
| aH5N1c - Low dose | EXPERIMENTAL | - |
| aH5N1c-High Dose | EXPERIMENTAL | Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart. |
| aH5N1c-Low dose | EXPERIMENTAL | Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart. |
| Name | Type | Description |
|---|---|---|
| Adjuvanted H5N1 pandemic influenza vaccine | BIOLOGICAL | Comparison of two doses of aH5N1c vaccine |
Inclusion Criteria: 1. Healthy elderly subjects ≥65 years, 2. Individuals willing to provide written informed consent, 3. Individuals in good health, 4. Individuals willing to allow for their serum samples to be stored beyond the study period. Exclusion Criteria: 1. Individuals not able to unders...
Adjuvanted H5N1 pandemic influenza vaccine is used for pandemic H5N1 influenza. It is an investigational vaccine being developed by Novartis AG (NVS) and is currently in Phase 2 clinical development. The vaccine is designed to protect against the H5N1 influenza strain, which has pandemic potential.
Adjuvanted H5N1 pandemic influenza vaccine is being developed by Novartis AG, which trades under the ticker NVS. The vaccine is currently in Phase 2 clinical development for pandemic H5N1 influenza. Novartis has conducted three completed clinical trials for this vaccine.
Adjuvanted H5N1 pandemic influenza vaccine is in Phase 2 clinical development. It is an investigational vaccine for pandemic H5N1 influenza and has not been approved by regulatory authorities. Three Phase 2 trials have been completed, with no active trials currently ongoing.
Adjuvanted H5N1 pandemic influenza vaccine has completed three Phase 2 trials: NCT01766921 in elderly subjects aged 65 years and older, NCT01776541 in healthy adults aged 18 years and older, and NCT01776554 in children aged 6 months and older. These trials assessed safety and immunogenicity of two vaccine doses.
Adjuvanted H5N1 pandemic influenza vaccine is a monoclonal antibody modality designed to target pandemic H5N1 influenza. It is formulated with an adjuvant to enhance the immune response. The vaccine is intended to stimulate the body's immune system to produce antibodies against the H5N1 influenza virus.
Adjuvanted H5N1 pandemic influenza vaccine is a specific formulation of an H5N1 influenza vaccine that includes an adjuvant. It is being developed by Novartis AG for pandemic H5N1 influenza. The vaccine is currently in Phase 2 clinical development and has been studied in three completed trials.