Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...