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Cell culture-derived influenza vaccine · 2 trials · 1 indication
The vaccine efficacy of CCI and IVV vaccines was estimated relative to Placebo group as the number of subjects prevented against virus-confirmed symptomatic influenza illness caused by each of three vaccine-like virus strains.
To assess the safety and tolerability in terms of number of adult and elderly subjects reporting solicited adverse events following one dose of the cTIV or the TIV vaccine .
| Arm | Type | Description |
|---|---|---|
| CCI | EXPERIMENTAL | Subjects received one dose of cell culture-derived influenza vaccine. |
| IVV | EXPERIMENTAL | Subjects received one dose of the trivalent egg-derived influenza vaccine. |
| Placebo | PLACEBO_COMPARATOR | Subjects received one dose of phosphate buffered solution (PBS). |
| cTIV\cTIV (adults) | ACTIVE_COMPARATOR | Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study. |
| cTIV\TIV (adults) | ACTIVE_COMPARATOR | Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study. |
| cTIV\cTIV (elderly) | ACTIVE_COMPARATOR | Subjects (≥61 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study. |
| cTIV\TIV (elderly) | ACTIVE_COMPARATOR | Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study. |
| TIV\TIV (adults) | ACTIVE_COMPARATOR | Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study. |
| TIV\cTIV (adults) | ACTIVE_COMPARATOR | Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study. |
| TIV\TIV (elderly) | ACTIVE_COMPARATOR | Subjects (≥61 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study. |
| TIV\cTIV (elderly) | ACTIVE_COMPARATOR | Subjects (≥61 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study. |
| Name | Type | Description |
|---|---|---|
| Cell culture-derived influenza vaccine | BIOLOGICAL | One dose (0.5 mL) of cell culture-derived influenza vaccine, administered in the deltoid muscle. |
| Egg-derived influenza virus vaccine | BIOLOGICAL | One dose (0.5 mL) of the trivalent egg-derived influenza virus vaccine, administered in the deltoid muscle. |
| Placebo | BIOLOGICAL | One dose (0.5 mL) of phosphate buffered solution. |
| Cell culture derived influenza vaccine | BIOLOGICAL | as a single IM injection of 0.5 ml in the deltoid muscle, preferably of the non-dominant arm |
| egg-derived influenza subunit vaccine | BIOLOGICAL | as a single IM injection of 0.5 ml in the deltoid muscle, preferably of the non-dominant arm |
Inclusion Criteria: 1. subjects 18 to 49 years of age; 2. in good health as determined by medical history and physical examination; 3. able and willing to provide written informed consent prior to any study procedure; 4. able to comply with all study procedures, including availability and willingne...
Cell culture-derived influenza vaccine is an investigational vaccine being developed for the prevention of influenza. It is currently in Phase 3 clinical development. The vaccine is intended for use in adults and elderly populations to provide protection against seasonal influenza infection.
Cell culture-derived influenza vaccine is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting Phase 3 clinical trials to evaluate the vaccine's safety, tolerability, and immunogenicity in adult and elderly populations.
Cell culture-derived influenza vaccine is currently in Phase 3 clinical development. It is an investigational vaccine and has not yet been approved by regulatory authorities. Two Phase 3 clinical trials have been completed, involving a total of 13,639 participants, to assess the vaccine's efficacy and safety profile.
Cell culture-derived influenza vaccine has been evaluated in two completed Phase 3 clinical trials. The first trial, NCT00306527, compared the safety, tolerability, and immunogenicity of influenza vaccines in adults and elderly, enrolling 2,235 participants in Poland. The second trial, NCT00630331, assessed the efficacy of two influenza vaccines versus placebo in 11,404 healthy adults across the United States, Finland, and Poland.
No, Cell culture-derived influenza vaccine is not a monoclonal antibody. It is classified as a vaccine, specifically a cell culture-derived influenza vaccine, designed to stimulate the immune system to produce antibodies against influenza viruses. The modality listed for this product is monoclonal antibody, but the product itself is a vaccine.
The clinical trials for Cell culture-derived influenza vaccine used a placebo-controlled design. In the Phase 3 efficacy study, NCT00630331, the vaccine was compared against placebo in healthy adult subjects. The trials were randomized but not double-blinded, and they enrolled healthy volunteers aged 18 years and older.