Phase 3
N=6,790
Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT02587221 ↗Enrolled (actual)
6,790
Serious AEs
7.0%
Results posted
Jun 2020
Primary outcome: Primary: Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on RT-PCR-confirmed Influenza Due to Any Strain Using Protocol Defined ILI Definition. — 122; 151 Number of cases
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV) (Biological); Non-Influenza Comparator (Boostrix) (Biological)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Seqirus
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on RT-PCR-confirmed Influenza Due to Any Strain Using Protocol Defined ILI Definition. |
122; 151 | — |
| PRIMARY Safety Endpoint: The Percentage of Subjects in the Solicited Safety Subset With Solicited Local and Systemic Adverse Events (AE) |
34.3; 32.2; 24.4; 19.6; 19.2; 16.3 | — |
| PRIMARY Safety Endpoint: Percentage of Subjects With Medically-attended Adverse Events (MAAEs) |
0.7; 0.4 | — |
| PRIMARY Safety Endpoint: Percentages of Subjects With Any Unsolicited AE |
21.5; 21.2 | — |
| PRIMARY Safety Endpoint: Percentages of Subjects With Serious Adverse Events (SAE), AEs Leading to Withdrawal, New Onset of Chronic Disease (NOCD), and Adverse Events of Special Interest (AESI) |
7.0; 6.9; 0.0; 0.0; 1.1; 1.1 | — |
| SECONDARY Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on RT-PCR-confirmed Influenza Due to Any Strain Using Modified CDC ILI Definition. |
83; 121 | — |
| SECONDARY Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Antigenically Matched to the Strains Selected for the Seasonal Vaccine Using Protocol Defined ILI Definition. |
7; 14 | — |
| SECONDARY Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Antigenically Matched to the Strains Selected for the Seasonal Vaccine Using Modified CDC ILI Definition. |
5; 13 | — |
| SECONDARY Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Regardless of Antigenic Match Using Protocol Defined ILI Definition. |
58; 81 | — |
| SECONDARY Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Regardless of Antigenic Match Using Modified CDC ILI Definition. |
44; 66 | — |
| SECONDARY Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Antigenically Unmatched to the Strains Selected for the Seasonal Vaccine Using Protocol Defined ILI Definition. |
51; 67 | — |
| SECONDARY Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Antigenically Unmatched to the Strains Selected for the Seasonal Vaccine Using Modified CDC ILI Definition. |
39; 53 | — |
| SECONDARY Immunogenicity Endpoint: Geometric Mean Hemagglutination Inhibition (HI) Titers (GMT) |
31.86; 36.19; 438.79; 29.43; 28.31; 27.56 | — |
| SECONDARY Immunogenicity Endpoint: Geometric Mean Ratio (GMR) of Post-vaccination HI Titer Over the Pre-vaccination HI Titer |
14.17; 0.89; 22.65; 1.08; 6.58; 0.97 | — |
| SECONDARY Immunogenicity Endpoint: Percentages of Subjects With an HI Titer ≥1:40 |
96.2; 46.7; 95.6; 41.7; 79.2; 21.5 | — |
| SECONDARY Immunogenicity Endpoint: Percentages of Subjects Who Achieved Seroconversion (SCR) |
78.0; 2.1; 84.6; 3.9; 60.8; 3.6 | — |
Summary
A Phase III, Randomized, Observer-Blind, Controlled, Multicenter Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age.
Eligibility Criteria
Inclusion Criteria
- Males and females ≥ 65 years old who are healthy or have co-morbidities
- Individuals who or whose legal guardian have voluntarily given written consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
- Ability to attend all scheduled visits and to comply with study procedures
Exclusion Criteria
- Hypersensitivity, including allergy to any component of vaccines foreseen in this study
- Abnormal function of the immune system.
- Receipt of any influenza vaccine within 6 months prior to enrolment in this study or who plan to receive influenza vaccine while participating in the study.
- Additional eligibility criteria may be discussed by contacting the site
Data sourced from ClinicalTrials.gov (NCT02587221). 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.