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QIV-HD by · 1 trial · 1 indication
An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of symptom and/or onset post-vaccination. Unsolicited AEs includes both serious and non-serious unsolicited AEs. A serious adverse event is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB.
A solicited reaction was an adverse reaction observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the CRB and considered as related to the administered vaccination. Solicited injection site reactions: pain, erythema, swelling, induration, and bruising. Solicited systemic reactions: fever, headache, malaise, myalgia, and shivering.
An unsolicited AE was an observed AE that does not fulfill the conditions prelisted in the CRB in terms of symptom and/or onset post-vaccination. Unsolicited AEs included both serious and non-serious unsolicited AEs. A serious adverse event is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: QIV-HD by IM | EXPERIMENTAL | Participants were randomized to receive a single 0.7-milliliter (mL) injection of QIV-HD by IM route on Day 0. |
| Cohort 1: QIV-HD by SC | EXPERIMENTAL | Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0. |
| Cohort 2: QIV-HD by IM | EXPERIMENTAL | Participants were randomized to receive a single 0.7 mL injection of QIV-HD by IM route on Day 0. |
| Cohort 2: QIV-HD by SC | EXPERIMENTAL | Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0. |
| Cohort 2: QIV-SD by SC | ACTIVE_COMPARATOR | Participants were randomized to receive a single 0.5 mL injection of QIV-SD by SC route on Day 0. |
| Name | Type | Description |
|---|---|---|
| QIV-HD by IM | BIOLOGICAL | IM, injected into the upper arm (deltoid area) |
| QIV-SD by SC | BIOLOGICAL | SC, injected into the upper arm (posterior region) |
| QIV-HD by SC | BIOLOGICAL | SC, injection into the upper arm (posterior region) |
Inclusion Criteria: * Aged \>= 65 years on the day of inclusion. * Informed consent form has been signed and dated. * Able to attend all scheduled visits and to comply with all study procedures. Exclusion Criteria: * Participation at the time of study enrollment (or in the 4 weeks preceding the s...
QIV-HD by is a high-dose quadrivalent influenza vaccine being developed for the prevention of influenza. It is intended for use in adults aged 65 years and older, a population at higher risk for influenza-related complications. The vaccine is designed to provide protection against four influenza virus strains.
QIV-HD by is being developed by Sanofi, a multinational pharmaceutical company. Sanofi's stock is traded under the ticker symbol SNY. The company is conducting clinical development of this high-dose quadrivalent influenza vaccine for use in older adults.
QIV-HD by is in Phase 1 clinical development. It is an investigational vaccine and has not yet been approved by regulatory authorities. The Phase 1 trial has been completed, and the vaccine remains in the early stages of clinical testing for safety and immunogenicity.
QIV-HD by has been studied in one completed Phase 1 clinical trial, identified as NCT03233217. This trial, titled "Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Patients ≥65 Years," enrolled 175 healthy volunteers aged 65 years and older in Japan. The study was randomized, double-blind, and actively controlled.
QIV-HD by is a high-dose quadrivalent influenza vaccine, meaning it contains a higher dose of antigen compared to standard-dose flu vaccines. It is designed to elicit a stronger immune response in older adults, who typically have a weaker response to standard vaccines. It targets four influenza strains.