Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Quadrivalent Inactivated Influenza High Dose · 1 trial · 2 indications
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report form (CRF) in terms of diagnosis and onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs that occurred during that time were recorded as immediate unsolicited AEs in the CRF. Reported AEs for each arm were presented as pre-specified in the study protocol.
A solicited reaction (SR) was an "expected" adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF. Solicited injection site reactions included injection site pain, axillary swelling and tenderness, injection site erythema, injection site swelling, injection site induration, and injection site bruising. Reported AEs for each arm were presented as pre-specified in the study protocol.
A SR 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 CRF. Solicited systemic reactions included fever, headache, malaise, myalgia, arthralgia, shivering, fatigue, nausea and vomiting. Reported AEs for each arm were presented as pre-specified in the study protocol.
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Reported AEs for each arm were presented as pre-specified in the study protocol.
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 one of scientific and medical concern specific to the sponsor's study intervention or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor was done. Reported AEs for each arm were presented as pre-specified in the study protocol.
A MAAE was a new onset or a worsening of a condition that prompted the participant or participant's parent/legally acceptable representative to seek unplanned medical advice at a physician's office or emergency department including medical advice seeking during the study visit or routine medical care. Reported AEs for each arm were presented as pre-specified in the study protocol.
GMTs of anti-influenza and anti-COVID-19 antibodies were measured using hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Yamagata, and B/Victoria. Titers were expressed in terms of 1/dilution.
GMTs of anti-influenza and anti-COVID-19 antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Yamagata, and B/Victoria. Titers were expressed in terms of 1/dilution.
GMTs of anti-influenza and anti-COVID-19 antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. GMTRs were calculated as the ratio of GMTs post-vaccination (on Day 22) and pre-vaccination (on Day 1) i.e., Day 22/Day 01.
Anti-influenza and anti-COVID 19 antibodies were measured using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Percentage of participants with HAI titers \>=10 (1/dilution) are reported in the outcome measure.
Anti-influenza and anti-COVID-19 antibodies were measured by HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Seroconversion was defined as either a pre-vaccination HAI titer less than (\<)10 (1/dilution) and a post-vaccination titer \>=40 (1/dilution) or a pre-vaccination titer \>=10 (1/dilution) and a \>= four-fold increase in post-vaccination titer at Day 22.
Anti-influenza and anti-COVID 19 antibodies were measured using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Percentage of participants with HAI titers \>=40 (1/dilution) are reported in the outcome measure.
GMCs of Anti-S binding IgG antibodies were assessed using enzyme-linked immunosorbent assay (ELISA) method and were measured in binding antibody units/milliliter (BAU/mL).
GMCs of Anti-S binding IgG antibodies were assessed using ELISA method. GMCR was calculated as the ratio of GMC post-vaccination (on Day 22) and pre-vaccination (on Day 1) i.e., Day 22/Day 01.
Percentage of participants with \>=2-fold and \>=4-fold rise in Anti-S binding IgG antibodies at Day 22 (post-vaccination) are reported in this outcome measure. Percentage of participants with \>=2-fold rise are those for whom the computed value at Day 22 was \*2 compared to the computed value at Day 1 and percentage of participants with \>=4-fold rise are those for whom the computed value at Day 22 was \*4 compared to the computed value at Day 1.
| Arm | Type | Description |
|---|---|---|
| Group 1: Fluzone High-Dose (HD) Quadrivalent Influenza Vaccine and COVID-19 Vaccine | EXPERIMENTAL | Participants received an injection of 0.7 milliliters (mL), fluzone HD quadrivalent influenza vaccine, co-administered with 0.5 mL COVID-19 vaccine, intramuscularly (IM) on Day 1. |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | ACTIVE_COMPARATOR | Participants received a single injection of 0.7 mL fluzone HD quadrivalent influenza vaccine, IM on Day 1. |
| Group 3: COVID-19 Vaccine | ACTIVE_COMPARATOR | Participants received a single injection of 0.5 mL COVID-19 mRNA Vaccine, IM on Day 1. |
| Name | Type | Description |
|---|---|---|
| Quadrivalent Inactivated Influenza High Dose | BIOLOGICAL | Sterile suspension for injection in a pre-filled syringe Intramuscular injection |
| COVID-19 mRNA Vaccine (nucleoside modified) | BIOLOGICAL | Sterile suspension (white to off-white) in multidose vial Intramuscular injection |
Inclusion Criteria: * Aged greater than or equal to \>= 65 years of age on the day of inclusion. * In good health or with underlying medical condition(s) that were judged to be stable by the Investigator. A stable medical condition was defined as disease not requiring significant change in therapy ...
Quadrivalent Inactivated Influenza High Dose is used for influenza immunization in adults 65 years of age and older. It is an investigational high-dose quadrivalent influenza vaccine being studied for its ability to provide protection against influenza in this older adult population.
Quadrivalent Inactivated Influenza High Dose is being developed by Sanofi, a biopharmaceutical company traded on the stock exchange under the ticker symbol SNY. Sanofi is conducting clinical research to evaluate this high-dose influenza vaccine candidate.
Quadrivalent Inactivated Influenza High Dose is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. A Phase 2 clinical trial has been completed to evaluate its safety and immunogenicity.
Quadrivalent Inactivated Influenza High Dose was studied in a completed Phase 2 clinical trial registered as NCT04969276. This trial enrolled 306 participants aged 65 years and older in the United States and evaluated the vaccine when administered concomitantly or singly with a Moderna COVID-19 vaccine.
Quadrivalent Inactivated Influenza High Dose is a high-dose quadrivalent inactivated influenza vaccine, meaning it contains four influenza virus strains at a higher dose than standard influenza vaccines. It is specifically being studied for use in adults 65 years and older to potentially provide enhanced immune response.