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Monovalent A/H1N1 influenza vaccine · 5 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| low dose of antigen + low dose of adjuvant | EXPERIMENTAL | - |
| high dose of antigen + high dose of adjuvant | EXPERIMENTAL | - |
| high dose of antigen | EXPERIMENTAL | - |
| Group A (Seasonal TIV + 7.5mcg HA+ full dose MF59) | EXPERIMENTAL | - |
| Group B (Ajuvanted Seasonal TIV + 7.5mcg HA+ full dose MF59) | EXPERIMENTAL | - |
| Group C (7.5mcg HA+ full dose MF59) | EXPERIMENTAL | - |
| Group D (7.5mcg HA+ full dose MF59 + Seasonal TIV) | EXPERIMENTAL | - |
| Group E (3.75mcg HA+ ½ dose MF59+ Seasonal TIV) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Monovalent A/H1N1 influenza vaccine | BIOLOGICAL | This trial will be performed at multiple study sites in a population of healthy children and adolescent. Subjects will be randomized to receive 2 IM injections of low dose of antigen \& adjuvant, or high dose of antigen \& adjuvant, or high dose of antigen, according to the study groups. |
Inclusion Criteria: 1. Males and females 6 months of age to 17 years of age on the day of enrollment; 2. Subject's parents or legal guardians who have given written consent and the subjects has given assent consent, if applicable; 3. Individuals in good health; 4. Subjects, subject's parents or leg...
Monovalent A/H1N1 influenza vaccine is used for pandemic influenza and pandemic influenza disease. It is an investigational vaccine developed by Novartis AG (NVS) to protect against the swine-origin A/H1N1 influenza strain. The vaccine is currently in Phase 3 clinical development for these pandemic influenza indications.
Monovalent A/H1N1 influenza vaccine is being developed by Novartis AG, which trades under the ticker NVS. The company has conducted clinical trials of this investigational vaccine in healthy subjects ranging from 6 months of age to adults, with studies completed in multiple countries including Belgium, Germany, and the Dominican Republic.
Monovalent A/H1N1 influenza vaccine is in Phase 3 clinical development. It is an investigational vaccine, not yet approved by regulatory authorities. Novartis AG has completed four clinical trials for this vaccine, with three Phase 3 studies and one Phase 2 study, all of which have been completed.
Monovalent A/H1N1 influenza vaccine has completed four clinical trials. These include NCT00971100 and NCT00971542, Phase 3 studies in subjects aged 6 months to 17 years, and NCT00971906, a Phase 3 study in adults 18 years and older. NCT00992212 is a Phase 2 study in adults. All trials evaluated immunogenicity, safety, and tolerability.
Monovalent A/H1N1 influenza vaccine is designed to induce an immune response against the swine-origin A/H1N1 influenza virus. The clinical trials evaluated both adjuvanted and non-adjuvanted formulations of the vaccine to assess their immunogenicity, which measures the body's antibody response to the vaccine.
Monovalent A/H1N1 influenza vaccine is specifically formulated to target the pandemic A/H1N1 strain, unlike seasonal flu vaccines that cover multiple strains. One trial, NCT00992212, included subjects both vaccinated and not yet vaccinated against seasonal influenza 2009/10, indicating the vaccine is being studied separately from seasonal flu vaccination.