Phase 3
Completed N=1,778
Phase 3 Safety and Immunogenicity Study of aQIV in Elderly Adults
Influenza, Human
Source: ClinicalTrials.gov NCT03314662 ↗
Enrolled (actual)
1,778
Serious AEs
4.7%
Results posted
Jul 2020
Primary outcomePrimary: Immunogenicity Endpoint: The Geometric Mean Titer (GMT) and GMT Ratio for the Four Strains Included in the Vaccine, Non-inferiority Analysis. — 65.01; NA; NA; 75.16 Geometric mean titer
◆ Published Evidence
Established
43citations · ~7 / year
Immunogenicity and safety of MF59-adjuvanted quadrivalent influenza vaccine versus standard and alternate B strain MF59-adjuvanted trivalent influenza vaccines in older adults.
Summary
This phase 3 study is a randomized, double-blinded, comparator controlled, parallel-group, multicenter study of aQIV versus the US-licensed 2017-2018 adjuvanted trivalent influenza vaccine (aTIV-1, Fluad), and versus an adjuvanted trivalent influenza vaccine (aTIV-2), containing the alternate B strain.
Linked Publications
-
Immunogenicity and safety of MF59-adjuvanted quadrivalent influenza vaccine versus standard and alternate B strain MF59-adjuvanted trivalent influenza vaccines in older adults.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Immunogenicity Endpoint: The Geometric Mean Titer (GMT) and GMT Ratio for the Four Strains Included in the Vaccine, Non-inferiority Analysis. |
65.01; NA; NA; 75.16; 294.91; NA | — |
| PRIMARY Immunogenicity Endpoint: The Difference Between the Seroconversion Rate (SCR) for the Four Strains Included in the Vaccine, Non-inferiority Analysis |
35.21; 39.45; 37.41; 39.33; 39.70; 37.18 | — |
| PRIMARY Immunogenicity Endpoint: The Percentage of Subjects Achieving SCR for Hemagglutination Inhibition (HI) Antibody for the Four Strains Included in the Vaccine. |
35.21; 39.45; 37.41; 39.33; 39.70; 37.18 | — |
| PRIMARY Immunogenicity Endpoint: The Percent of Subjects Achieving an HI Antibody Titer ≥ 1:40 for the Four Strains Included in the Vaccines. |
69.38; 71.79; 68.82; 93.92; 94.72; 94.92 | — |
| SECONDARY Immunogenicity Endpoint: Geometric Mean Titers (GMT) Against Homologous Strains |
19.07; NA; NA; 18.77; 57.07; NA | — |
| SECONDARY Immunogenicity Endpoint: Geometric Mean Ratio (GMR) of Post Vaccination HI Titer Over the Pre-vaccination HI Titer Against Homologous Strains |
2.99; NA; NA; 3.40; 3.36; NA | — |
| SECONDARY Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 Against Homologous Strains |
33.26; NA; NA; 31.07; 69.38; NA | — |
| SECONDARY Immunogenicity Endpoint: The Percentage of Subjects With SCR Against Homologous Strains |
35.21; NA; NA; 38.43; 39.33; NA | — |
| SECONDARY Safety Endpoint: Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following Vaccination |
385; 170; 167; 231; 107; 110 | — |
| SECONDARY Safety Endpoint: Number of Subjects With Unsolicited AEs |
136; 50; 68 | — |
| SECONDARY Safety Endpoint: Number of Subjects With Serious AEs (SAEs), AEs Leading to Withdrawal From the Study, New Onset of Chronic Diseases (NOCDs) and AEs of Special Interest (AESIs) |
37; 28; 18; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Males and females ≥ 65 years old who are healthy or have co-morbidities
- Individuals who or whose legal representative(s) 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 including diary card completion and follow-up
Exclusion Criteria
- History of behavioral or cognitive impairment or psychiatric condition
- Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study
- Abnormal function of the immune system
- Receipt of any influenza vaccine within 6 months prior to enrollment in this study, or plan to receive influenza vaccine prior to the Day 22 blood collection
- Any other clinical condition that, in the opinion of the Investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study
Additional eligibility criteria may be discussed by contacting the site.
Data sourced from ClinicalTrials.gov (NCT03314662) and the linked publication. 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. Informational only — not medical advice.