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Influenza virus vaccine · 3 trials · 3 indications
Seroprotection was defined as a Reciprocal Hemagglutination Inhibition Titers of ≥ 40 Post-vaccination with Fluzone® Vaccine.
Seroprotection was defined as a titer ≥ 40 1/dil, and determined in participants with a valid serology result for the particular Flu strain, including results reported as less than lower limit of quantitation (LLOQ)
Seroconversion: For participants with a Day 0 pre-vaccination titer \< 10 (1/dil), titer ≥ 40 (1/dil) on Day 21. Significant Increase: For participants with a Day 0 pre-vaccination titer ≥ 10 (1/dil), ≥ 4-fold increase of titer on Day 21.
Solicited local (injection site) reactions: Tenderness, erythema (redness), and swelling Solicited systemic reactions: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Loss of Appetite, and Irritability.
| Arm | Type | Description |
|---|---|---|
| Fluzone® Vaccine-Primed Group | EXPERIMENTAL | Participants received 2 doses of Fluzone® vaccine at 2 months (in Study GRC 27) |
| Influenza Vaccine-Naive Group | ACTIVE_COMPARATOR | Participants who have never received influenza vaccine (and not in Study GRC27) |
| Group 1: Standard-dose Cell-based Influenza Vaccine | EXPERIMENTAL | Participants will receive a single dose of standard-dose cell-based influenza virus vaccine. |
| Group 2: High-dose Cell-based Influenza Vaccine | EXPERIMENTAL | Participants will receive a single dose of high-dose cell-based influenza virus vaccine. |
| Group 3: Licensed Fluzone® Influenza Vaccine | ACTIVE_COMPARATOR | Participants will receive a single dose of licensed Fluzone® influenza vaccine. |
| Group 1 | EXPERIMENTAL | Participants aged 6 to 12 Weeks at enrollment |
| Group 2 | EXPERIMENTAL | Participants aged 24 to 36 Weeks at enrollment |
| Name | Type | Description |
|---|---|---|
| Influenza Virus Vaccine | BIOLOGICAL | 0.25 mL, Intramuscular |
| Influenza virus vaccine - cell based (2007-2008 Formulation) | BIOLOGICAL | 0.5 mL, Intramuscular |
| Influenza virus vaccine - cell-based (2007-2008 Formulation) | BIOLOGICAL | 1.0 mL, Intramuscular |
| Influenza virus vaccine (2007-2008 Formulation) | BIOLOGICAL | 0.5 mL, Intramuscular |
| Influenza virus vaccine (2004-2005 Formulation) | BIOLOGICAL | 0.25 mL, Intramuscular |
Inclusion Criteria: * Participant is between 6 and 10 months of age on the day of inclusion (has reached 6-month but has not reached 11-month anniversary of birth). * Available for the duration of the study. * Born at full term of pregnancy (≥ 36 weeks) with a birth weight ≥ 2.5 kg * Parent/legal a...
Influenza virus vaccine is used for the prevention of influenza, a viral respiratory infection caused by orthomyxoviruses. It is being developed by Sanofi and is currently in Phase 3 clinical development. The vaccine is intended to stimulate an immune response against influenza viruses to reduce the risk of infection and associated complications.
Sanofi (ticker: SNY) is developing the Influenza virus vaccine. The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity in various populations, including healthy adults, children, and infants. Sanofi is a global biopharmaceutical company focused on vaccines and other healthcare products.
Influenza virus vaccine is in Phase 3 clinical development. It has completed three clinical trials, including one Phase 3 study, one Phase 2 study, and one Phase 1 study. The vaccine is investigational and has not yet been approved by regulatory authorities. It is being evaluated for safety and immunogenicity in different age groups.
Influenza virus vaccine has completed three clinical trials: NCT00845429, a Phase 2 study in healthy adults; NCT00858468, a Phase 1 study in children aged 2 to 6 months; and NCT00885105, a Phase 3 study in infants aged 6 months and older. All trials were conducted in the United States and have been completed.
Yes, Influenza virus vaccine is the same as Fluzone. One of the completed clinical trials, NCT00885105, specifically evaluates responses to Fluzone in infants. Fluzone is a brand name for an inactivated influenza vaccine developed by Sanofi, and it is being studied for use in pediatric populations.