Phase 3
N=2,100
Study to Assess the Immune Response and the Safety Profile of a High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Compared to a Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) in Japanese Adults 60 Years of Age and Older
Influenza Immunization · Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT04498832 ↗Enrolled (actual)
2,100
Serious AEs
0.3%
Results posted
Feb 2022
Primary outcome: Primary: Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 28 — 309.0; 110.0; 540.0; 239.9 titers
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- High-Dose Quadrivalent Influenza Vaccine, (Zonal Purified, Split Virus) 2020-2021 Strains (QIV-HD) (Biological); Local Standard-Dose Inactivated Quadrivalent Influenza Vaccine, 2020-2021 Strains (QIV-SD) (Biological)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 28 |
309.0; 110.0; 540.0; 239.9; 354.8; 139.2 | — |
| PRIMARY Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens: Superiority Analysis |
77.6; 47.9; 75.4; 47.3; 79.2; 47.8 | — |
| SECONDARY GMTs of Influenza Vaccine Antibodies at Day 0 and Day 28 |
14.5; 14.9; 309.0; 110.0; 54.9; 54.6 | — |
| SECONDARY Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine Antibodies |
21.33; 7.33; 13.14; 5.86; 13.23; 5.85 | — |
| SECONDARY Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens |
77.6; 47.9; 76.4; 48.2; 75.4; 47.3 | — |
| SECONDARY Percentage of Participants With HAI Titers >=40 (1/Dilution) Against Influenza Antigens |
16.1; 18.2; 85.1; 67.6; 52.3; 51.7 | — |
| SECONDARY Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs) |
0; 1 | — |
| SECONDARY Number of Participants Reporting Solicited Injection Site and Systemic Reactions |
503; 334; 86; 328; 82; 185 | — |
| SECONDARY Number of Participants Reporting Unsolicited Adverse Events (AEs) |
71; 85 | — |
| SECONDARY Number of Participants Reporting Serious Adverse Events (SAEs) |
2; 5 | — |
Summary
Primary Objective:
To demonstrate that QIV-HD induced an immune response (as assessed by hemagglutination inhibition [HAI] geometric mean titers [GMTs] and seroconversion rates) that was superior to responses induced by QIV-SD for the 4 virus strains at 28 days post-vaccination in all participants.
Secondary Objective:
* To describe the immune response induced by QIV-HD and QIV-SD by HAI measurement method in all participants.
* To describe the safety profile of all participants in each study group.
Eligibility Criteria
Inclusion criteria
- Aged greater than or equal to (>=) 60 years 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 the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.
- Receipt of any vaccination with live vaccines within the past 27 days preceding the study vaccination or any vaccination with inactivated vaccines within the past 6 days preceding the study vaccination, or planned receipt of any vaccine prior to Visit 02.
- Previous vaccination against influenza (in the preceding 6 months) with either the study vaccine or another vaccine.
- Receipt of immune globulins, blood or blood-derived products in the past 3 months.
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
- Known systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the study or to a vaccine containing any of the same substances.
- Thrombocytopenia or bleeding disorder, contraindicating IM vaccination based on Investigator's judgment.
- Alcohol or substance abuse that, in the opinion of the Investigator might interfere with the study conduct or completion.
- Chronic illness that, in the opinion of the Investigator, was at a stage where it might interfere with study conduct or completion.
- Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e.,parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.
- Personal or family history of Guillain-Barré syndrome.
- Neoplastic disease or any hematologic malignancy (except localized skin or prostate cancer that is stable at the time of vaccination in the absence of therapy and participants who have a history of neoplastic disease and have been disease free for >=5 years).
- Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature >=37.5 degree Celsius). A prospective participant was not be included in the study until the condition had resolved or the febrile event had subsided.
- History of convulsions.
- Any condition that in the opinion of the Investigator could interfere with the evaluation of the vaccine.
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Data sourced from ClinicalTrials.gov (NCT04498832). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.