Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03391193 | Immunogenicity and Safety of a Multi-Dose Quadrivalent Influenza Vaccine | PHASE3 | COMPLETED | 301 | — | — | Dec 19, 2017 | Aug 25, 2018 | Apr 25, 2022 | 3 | Mexico |
Anti-hemagglutinin (HA) antibody titers against the 4 influenza strains are assessed by a hemagglutination inhibition (HAI) assay
Anti-HA antibody titers against the 4 influenza strains are assessed by an HAI assay. GMT ratio is assessed as the individual ratio of post-/pre-vaccination titers
Anti-HA antibody titers against the 4 influenza strains are assessed by an HAI assay. Seroconversion is defined as either post-vaccination titer ≥ 40 (1/dil), or pre-vaccination titer ≥ 10 (1/dil) and ≥ 4-fold increase in post-vaccination titer
| Arm | Type | Description |
|---|---|---|
| Multi-dose Quadrivalent Influenza Vaccine | EXPERIMENTAL | Quadrivalent influenza vaccine (split-virion, inactivated, 2017-2018 formulation, thiomersal containing) in multi-dose presentation. Participants aged 9 to 17 years will receive 1 dose and subjects aged 6 months to 8 years will receive 2 doses 28 days apart |
| Single-dose Quadrivalent Influenza Vaccine | ACTIVE_COMPARATOR | Quadrivalent influenza vaccine (split-virion, inactivated, 2017-2018 formulation, thiomersal free) in single-dose syringe presentation. Participants aged 9 to 17 years will receive 1 dose and subjects aged 6 months to 8 years will receive 2 doses 28 days apart |
| Name | Type | Description |
|---|---|---|
| Multi-dose Quadrivalent Influenza Vaccine | BIOLOGICAL | 0.5 mL, intramuscular |
| Single-dose Quadrivalent Influenza Vaccine | BIOLOGICAL | 0.5 mL, intramuscular |
Inclusion Criteria: * Aged 6 months to 17 years on the day of inclusion * Assent form has been signed and dated by the subject aged 7 to 17 years, and informed consent form has been signed and dated by the parent(s) or another legally acceptable representative and by an independent witness, if requ...