Approval Probability
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High-Dose Quadrivalent Influenza Vaccine · 1 trial · 1 indication
GMTs of anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria Lineage), and B2 (B Yamagata Lineage). Titers were expressed in terms of 1/dilution.
GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). Titers were expressed in terms of 1/dilution.
GMTRs of anti-influenza antibodies were measured by using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). GMTRs were calculated as the ratio of GMTs post-vaccination (on Day 28) and pre-vaccination (on Day 0).
Anti-influenza antibodies were measured by HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). Seroconversion was defined as either a pre-vaccination HAI titer less than (\<) 10 (1/dilution) at Day 0 and a post-vaccination titer greater than or equal to (\>=) 40 (1/dilution) at Day 28 or a pre-vaccination titer \>=10 (1/dilution) at Day 0 and a \>= four-fold increase in post-vaccination titer at Day 28.
Antibody titer was measured by using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage).
Antibody titer was measured using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage).
An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not had any causal relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited systemic AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB.
A solicited reaction was an "expected" adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to the product administered. Solicited injection site reactions included pain, erythema, swelling, induration, and bruising. Solicited systemic reactions included fever, headache, malaise, myalgia and shivering.
An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not had any causal relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of diagnosis and/or onset window post-vaccination.
An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. AESIs was defined as event for which ongoing monitoring and rapid communication by the investigator to the sponsor was done.
| Arm | Type | Description |
|---|---|---|
| Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | EXPERIMENTAL | Participants received a single injection of 0.7 milliliters (mL) QIV-HD, intramuscularly (IM) at Day 0. |
| Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) | ACTIVE_COMPARATOR | Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0. |
| Name | Type | Description |
|---|---|---|
| High-Dose Quadrivalent Influenza Vaccine | BIOLOGICAL | Pharmaceutical form: Suspension for injection in pre-filled syringe, Route of administration: IM |
| Standard-Dose Quadrivalent Influenza Vaccine | BIOLOGICAL | Pharmaceutical form: Suspension for injection in pre-filled syringe, Route of administration: IM |
Inclusion criteria : * 65 years and older on the day of inclusion. * Able to attend all scheduled visits and complied with all study procedures. Exclusion criteria: * Participation at the time of study enrollment (or in the 4 weeks preceding the study vaccination) or planned participation during ...
High-Dose Quadrivalent Influenza Vaccine is used for the prevention of influenza in adults and children. It is an investigational vaccine being studied in healthy volunteers and in the general population to protect against seasonal flu. The vaccine is designed to provide immunity against four influenza virus strains.
Sanofi (ticker: SNY) is developing High-Dose Quadrivalent Influenza Vaccine. The company is conducting clinical trials to evaluate the vaccine's safety and effectiveness in preventing influenza across different age groups and geographic regions.
High-Dose Quadrivalent Influenza Vaccine is in Phase 3 clinical development. It is an investigational vaccine, meaning it has not yet been approved by regulatory authorities. Sanofi has completed four clinical trials, including three Phase 3 studies and one Phase 2 study, with a total enrollment of 24,250 participants.
High-Dose Quadrivalent Influenza Vaccine has completed four clinical trials. These include NCT01240746, a Phase 3 study in children in the United States; NCT03765437, a Phase 3 safety study in Vietnam; NCT04210349, a Phase 3 study in China; and NCT05048589, a Phase 2 feasibility study in Danish adults aged 65-79 years.
High-Dose Quadrivalent Influenza Vaccine is not the same as VaxigripTetra. VaxigripTetra is a standard-dose quadrivalent influenza vaccine, while High-Dose Quadrivalent Influenza Vaccine contains a higher antigen dose. They are distinct vaccine formulations developed by Sanofi for influenza prevention.