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Also known as Fluzone®
2009-2010 Trivalent Influenza Virus Vaccine · 1 trial · 1 indication
Solicited injection site reactions (6-23 Months): Tenderness, Redness and Swelling; Solicited systemic reactions: Fever, Abnormal crying, Drowsiness, Loss of appetite, Vomiting and Irritability Grade 3 Tenderness: cries when injected limb is moved; Redness and Swelling: ≥5 cm; Fever: \>103.1°F; Abnormal crying: \>3 hours; Drowsiness: Sleeping most of the time; Loss of appetite: refuses ≥3 feeds/meals; Vomiting: ≥6 episodes/24 hours; Irritability: inconsolable. (24-59 Months): Pain, Redness and Swelling; Fever, Headache, Malaise and Myalgia. Grade 3: Pain, Incapacitating; Redness and Swelling: ≥5 cm; Fever: \>102.1°F, Headache, Malaise and Myalgia: Significant, prevents daily activity. (Adults): Pain, Redness, Induration, and Ecchymosis; Fever, Headache, Malaise, Myalgia and Shivering. Grade 3: Pain: significant, prevents daily activities; Redness, Swelling, Induration and Ecchymosis: \>10 cm; Fever \>102.1°F; Headache, Malaise, Myalgia \& Shivering: Significant, prevents daily activity.
Immunogenicity outcomes were assessed in serum samples by Hemagglutination inhibition (HAI) assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10.
Immunogenicity outcomes were assessed in serum samples by Hemagglutination inhibition (HAI) assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10.
| Arm | Type | Description |
|---|---|---|
| Study Group 1 | EXPERIMENTAL | Participants will receive the 2009-2010 Trivalent Influenza Vaccine (TIV) (Pediatric dose have no preservatives) |
| Study Group 2 | ACTIVE_COMPARATOR | Participants will receive the 2008-2009 Trivalent Influenza Vaccine (TIV) |
| Study Group 3 | ACTIVE_COMPARATOR | Participants will receive the Quadrivalent Influenza Vaccine (QIV) |
| Name | Type | Description |
|---|---|---|
| 2009-2010 Trivalent Influenza Virus Vaccine | BIOLOGICAL | 0.25 mL, Intramuscular (participants at 6 to 35 months of age - Pediatric Dose); Others 0.5 mL, Intramuscular. |
| 2008-2009 Trivalent Influenza Virus Vaccine | BIOLOGICAL | 0.25 mL, Intramuscular; 0.5 mL, Intramuscular. |
| Quadrivalent Influenza Virus Vaccine | BIOLOGICAL | 0.5 mL, Intramuscular |
Inclusion Criteria : * Subject is ≥ 6 months to \< 5 years of age or 18 years of age or older on the day of inclusion. * Parent/legal guardian (if the subject is ≥ 6 months to \< 5 years of age) or adult subject (if 18 years of age or older) is willing and able to attend scheduled visits and to com...
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| Sinovac Biotech Ltd. | SVA | 1 | PHASE3 | Quadrivalent influenza vaccine (split virion), inactivated |
| Moderna, Inc. | MRNA | 2 | PHASE3 | mRNA-1018-H5, mRNA-1010, Fluarix Trivalent |
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| 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 |
The 2009-2010 Trivalent Influenza Virus Vaccine is an investigational vaccine developed by Sanofi for the prevention of influenza. It is a trivalent formulation, meaning it is designed to cover three influenza virus strains for the 2009-2010 season. It was studied in children and adults, including healthy volunteers as young as 6 months old.
The 2009-2010 Trivalent Influenza Virus Vaccine is being studied for the prevention of influenza, a contagious respiratory illness caused by influenza viruses. The clinical program enrolled healthy volunteers, including children and adults, in the United States. Its development targets seasonal influenza rather than a single non-seasonal strain.
Sanofi develops the 2009-2010 Trivalent Influenza Virus Vaccine. Sanofi is a global pharmaceutical company that trades under the ticker SNY. The company is the sponsor of the clinical program evaluating this trivalent influenza vaccine in children and adults.
The 2009-2010 Trivalent Influenza Virus Vaccine is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by the FDA. The Phase 2 study has been completed, and no trials of this vaccine are currently active.
The 2009-2010 Trivalent Influenza Virus Vaccine was evaluated in one completed Phase 2 trial, NCT00988143, titled A Study of Influenza Virus Vaccines in Children and Adults. The trial enrolled 600 participants in the United States, included healthy volunteers from 6 months of age, and used an active-controlled, randomized design.