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Also known as QIV-HD by IM
QIV-HD · 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...
Top 8 of 11 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 3 | PHASE3 | mRNA Seasonal Flu vaccine, Flu/COVID-19 mRNA combination vaccine |
| Sinovac Biotech Ltd. | SVA | 1 | PHASE3 | Quadrivalent influenza vaccine (split virion), inactivated |
| 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 |
QIV-HD is a high-dose quadrivalent influenza vaccine developed by Sanofi for the prevention of influenza, with its clinical program focused on adults aged 65 years and older. It is being studied in Japan as a higher-antigen formulation intended for older populations.
QIV-HD is developed by Sanofi, which trades under the ticker SNY. Sanofi is the sponsor of the vaccine's clinical development program, including the Phase 1 trial conducted in Japan in adults aged 65 years and older.
QIV-HD is in Phase 1 clinical development. It is an investigational vaccine and is not described as approved. One Phase 1 trial has been completed, and no active trials are currently listed for this asset.
QIV-HD has been evaluated in one completed Phase 1 trial, NCT03233217, titled Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Patients 65 Years and Older. The trial enrolled 175 participants in Japan, was randomized, double blind, and used an active control.
Yes. QIV-HD by IM is an alternative name for QIV-HD, the high-dose quadrivalent influenza vaccine developed by Sanofi. Both names refer to the same investigational asset studied in the completed Phase 1 trial NCT03233217.
The Phase 1 trial NCT03233217 was a randomized, double-blind, active-controlled study of QIV-HD in adults aged 65 years and older. It enrolled 175 participants in Japan, included healthy volunteers, and has been completed.