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Also known as Influenza virus vaccine (2004-2005 Formulation), High-dose influenza virus vaccine, Influenza virus vaccine (2007-2008 Formulation), Fluzone® 2005-2006 Pediatric Formulation
Influenza virus vaccine · 5 trials · 1 indication
Seroprotection was defined as a Reciprocal Hemagglutination Inhibition Titers of ≥ 40 Post-vaccination with Fluzone® Vaccine.
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 |
|---|---|---|
| Group 1 | EXPERIMENTAL | Participants at 18 to 59 years of age |
| Group 2 | EXPERIMENTAL | Participants at 60 years of age or older |
| 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) |
| Name | Type | Description |
|---|---|---|
| Influenza virus vaccine (split virion, inactivated) | BIOLOGICAL | 0.1 mL, Intradermal |
| Influenza Virus Vaccine | BIOLOGICAL | 0.25 mL, Intramuscular |
| Influenza virus (split virion, inactivated) vaccine | BIOLOGICAL | 0.5 mL, Intramuscular |
| Influenza virus vaccine (2004-2005 Formulation) | BIOLOGICAL | 0.25 mL, Intramuscular |
Inclusion Criteria : * Aged 18 years or over on the day of inclusion * Informed consent form has been signed and dated * Able to attend all scheduled visits and to comply with all trial procedures * For a woman of childbearing potential, use of an effective method of contraception or abstinence fro...
Top 8 of 11 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 3 | PHASE3 | mRNA Seasonal Flu vaccine, Flu/COVID-19 mRNA combination vaccine |
| Sinovac Biotech Ltd. | SVA | 1 | PHASE3 | Quadrivalent influenza vaccine (split virion), inactivated |
| Moderna, Inc. | MRNA | 2 | PHASE3 | mRNA-1018-H5, mRNA-1010, Fluarix Trivalent |
| Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | CDTX | 1 | PHASE3 | CD388 |
| Traws Pharma, Inc. | TRAW | 2 | PHASE2 | TRX-100 |
| Sanofi SA Sponsored ADR | SNY | 4 | PHASE1 | H5N8 pandemic influenza vaccine (adjuvanted) |
| Hoffmann-La Roche | RHHBY | 2 | PHASE3 | Baloxavir Marboxil |
| AstraZeneca PLC | AZN | 1 | PHASE1 | AZD4117, AZD5315 |
Influenza virus vaccine is used to prevent influenza, the viral respiratory infection commonly called the flu. It is an infectious disease vaccine developed by Sanofi. The clinical program covers several formulations, including split virion, inactivated vaccine and high-dose presentations, tested in healthy volunteers and in infants from 6 months of age.
Influenza virus vaccine is developed by Sanofi, which trades under the ticker SNY. Sanofi's Fluzone brand appears in the clinical program, including a trial evaluating responses to Fluzone in infants. The vaccine candidates in this program have been studied across multiple Northern Hemisphere influenza seasons and formulations.
Influenza virus vaccine has been studied in Phase 3 clinical development, with five completed trials in the program. No trials are currently listed as active. The studies enrolled a total of 1,024 participants and included both Phase 2 and Phase 3 evaluations of immunogenicity and safety.
The program includes completed trials NCT01138397 and NCT01121822, which tested intradermal and intramuscular administration during the 2010-2011 Northern Hemisphere season. NCT00946179 evaluated the 2009-2010 split virion, inactivated formulation, and NCT00885105 assessed responses to Fluzone in infants aged 6 months and older.
Influenza virus vaccine is also known as Influenza virus (split virion, inactivated) vaccine, high-dose influenza virus vaccine, and by season-specific names such as the 2004-2005 and 2007-2008 formulations. Fluzone is the Sanofi brand name referenced in one of the clinical trials of this vaccine program.
The five completed trials were randomized and controlled, with enrollment ranging from 129 to 242 participants per study. Trials were conducted in Belgium, France, Switzerland, and the United States. Participants were healthy volunteers, including adults aged 18 years and older and infants from 6 months of age.