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Quadrivalent influenza vaccine Northern Hemisphere 2015-2016 · 1 trial · 1 indication
Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique.
Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique. Seroprotection was defined as titers ≥ 40 (1/dil) on Day 0 and Day 21.
Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique.
Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique. Seroconversion was defined as titers \< 10 (1/dil) on Day 0 and post-injection titer ≥ 40 (1/dil) on Day 21, and Significant increase was defined as titers ≥ 10 (1/dil) on Day 0 and ≥ 4-fold increase of post-injection titer on Day 21.
Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique.
The solicited reactions evaluated were Injection-site Induration (≥50 mm for at least 4 consecutive days), Injection-site Ecchymosis (injection site bruising), Pyrexia (recorded temperature \>38.0˚C for at least 1 day), Malaise, and Shivering (rigors).
Solicited Injection-site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Grade 3: Pain, Significant; prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis, \>100 mm. Grade 3 Solicited Systemic reactions: Fever, ≥ 39.0˚C; Headache, Malaise, Myalgia, and Shivering, Significant; prevents daily activity.
| Arm | Type | Description |
|---|---|---|
| QIV Group | EXPERIMENTAL | Subjects will receive one dose of the Quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 formulation |
| TIV Group | ACTIVE_COMPARATOR | Subjects will receive one dose of the Trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation |
| Name | Type | Description |
|---|---|---|
| Quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 | BIOLOGICAL | 0.5 mL, Intramuscular |
| Trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation | BIOLOGICAL | 0.5 mL, Intramuscular |
Inclusion Criteria: * Aged 18 to 60 years on the day of inclusion * Subjects aged 18 years: Assent form has been signed and dated by the subject or by an independent witness, and informed consent form has been signed and dated by at least one parent or another legally acceptable representative or b...
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|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 3 | PHASE3 | mRNA Seasonal Flu vaccine, Flu/COVID-19 mRNA combination vaccine |
| 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 |
| Sinovac Biotech Ltd. | SVA | 1 | PHASE1 | Cell-based Trivalent Split Influenza Virus Vaccine, Egg-based Trivalent Split Influenza Virus Vaccine |
It is a split virion, inactivated quadrivalent influenza vaccine formulated for the Northern Hemisphere 2015-2016 season. It is designed to protect against influenza and was studied in healthy adults aged 18 to 60 years. The vaccine is given by intramuscular injection and is also known as QIV (split virion, inactivated) Northern Hemisphere 2015-2016.
It is used for the prevention of influenza. The vaccine is intended to immunize against circulating influenza strains included in the Northern Hemisphere 2015-2016 formulation. Its clinical study enrolled healthy volunteers aged 18 to 60 years in South Korea.
Sanofi develops the Quadrivalent influenza vaccine Northern Hemisphere 2015-2016. Sanofi trades under the ticker SNY. The company is the sponsor of the clinical program for this seasonal influenza vaccine.
The Quadrivalent influenza vaccine Northern Hemisphere 2015-2016 is in Phase 3 development. One Phase 3 trial has been completed. The vaccine is investigational and is not described as approved.
The Quadrivalent influenza vaccine Northern Hemisphere 2015-2016 was evaluated in a completed Phase 3 trial, NCT02550197, titled Immunogenicity and Safety of a Quadrivalent Influenza Vaccine Given by Intramuscular Route in Subjects Aged 18 to 60 Years. The trial enrolled 300 participants in South Korea and was active-controlled and randomized.