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Safety and Immunogenicity of an MF59-Adjuvanted Influenza Vaccine in Older Adults

Sponsor
Seqirus (Industry)
Overall Status
Completed
CT.gov ID
NCT04576702
Collaborator
(none)
471
Enrollment
21
Locations
4
Arms
11.9
Actual Duration (Months)
22.4
Patients Per Site
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This Phase 2, randomized, observer-blind, active controlled clinical study is evaluating the safety and immunogenicity of the investigational MF59-Adjuvanted Quadrivalent Subunit Inactivated Influenza Vaccine. Approximately 480 subjects are to be randomized into 1 of 4 possible treatment groups (investigational Influenza Vaccine or licensed Quadrivalent Influenza Vaccine comparators) at 120 participants per group. Every participant will receive an influenza vaccine injection on Day 1 and will be followed up for approximately 6 months following injection. The primary immunogenicity analysis is based on Day 29 serum.

Condition or Disease Intervention/Treatment Phase
  • Biological: Investigational aIIV4c
  • Biological: IIV4c type 1
  • Biological: aIIV4
  • Biological: RIV4 type 2
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
471 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
A Phase 2, Randomized, Stratified, Observer-Blind Clinical Study to Evaluate Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Subunit Inactivated Influenza Vaccine in Older Adults
Actual Study Start Date :
Oct 8, 2020
Actual Primary Completion Date :
Mar 19, 2021
Actual Study Completion Date :
Oct 6, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Investigational aIIV4c group

aIIV4c will be administered as a single dose intramuscularly on Day 1

Biological: Investigational aIIV4c
Investigational MF59 Adjuvanted Cell-derived Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
Active Comparator: licensed IIV4c type 1 group

IIV4c will be administered as a single dose intramuscularly on Day 1

Biological: IIV4c type 1
Licensed, Non-adjuvanted, Cell-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.
Active Comparator: licensed aIIV4 group

aIIV4 will be administered as a single dose intramuscularly on Day 1

Biological: aIIV4
Licensed, MF59-Adjuvanted, egg-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.
Active Comparator: licensed RIV4 type 2 group

RIV4 will be administered as a single dose intramuscularly on Day 1

Biological: RIV4 type 2
Licensed, Recombinant Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.

Outcome Measures

Primary Outcome Measures

  1. Immunogenicity Endpoint: Hemagglutination inhibition (HI) titers against vaccine A and B influenza strains [28 days post-vaccination]

Secondary Outcome Measures

  1. Safety Endpoint: The Percentage of Subjects With Solicited Local and Systemic Reactions [7 days post-vaccination]

  2. Safety Endpoint: The Percentage of Subjects with Unsolicited Adverse Events [28 days post-vaccination]

  3. Safety Endpoint: The Percentage of Subjects with Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) [180 days post-vaccination]

  4. Immunogenicity Endpoint: Microneutralization (MN) titers against vaccine A and B influenza strains [28 days post-vaccination]

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  1. Individuals 50 years of age and older on the day of informed consent.

  2. Individuals who have voluntarily given written consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.

  3. Individuals who can comply with study procedures including follow-up.

  4. Males, females of non-childbearing potential or females of childbearing potential who are using an effective birth control method, at least 30 days prior to informed consent, which they intend to use for at least 2 months after the study vaccination.

Exclusion Criteria:

  1. Females of childbearing potential who are pregnant, lactating, or who have not adhered to a specified set of contraceptive methods from at least 30 days prior to informed consent and who do not plan to do so until 2 months after the study vaccination.

  2. Progressive, unstable or uncontrolled clinical conditions.

  3. Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study.

  4. History of any medical condition considered an adverse event of special interest.

  5. Known history of Guillain Barré syndrome or another demyelinating disease such as encephalomyelitis and transverse myelitis.

  6. Clinical conditions representing a contraindication to intramuscular administration of vaccines or blood draw.

  7. Abnormal function of the immune system resulting from:

  8. Clinical conditions

  9. Systemic administration of corticosteroids (PO/IV/IM) at a dose of ≥ 20 mg/day of prednisone or equivalent for more than 14 consecutive days within 90 days prior to informed consent5.

  10. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent.

  11. Received immunoglobulins or any blood products within 180 days prior to informed consent.

  12. Received an investigational or non-registered medicinal product within 30 days prior to vaccination.

  13. Individuals who received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrolment in this study or who are planning to receive any vaccine within 28 days from the study vaccines.

  14. Study personnel or immediate family or household member of study personnel.

  15. Receipt of any influenza vaccine within 6 months prior to vaccination in this study, or plan to receive an influenza vaccine during the study period.

  16. Acute (severe) febrile illness

  17. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 4022 - Coastal Clinical Research, an AMR company Mobile Alabama United States 36608
2 4002 - Clinical Research Consortium, an AMR company Tempe Arizona United States 85283
3 4006 - Westside Center for Clinical Research Jacksonville Florida United States 32205
4 4013 - Jacksonville Center for Clinical Research Jacksonville Florida United States 32216
5 4021 - Research Centers of America, LLC Oakland Florida United States 33334
6 4023 - Advanced Clinical Research Boise Idaho United States 83642
7 4010 - Heartland Research Associates, LLC Newton Kansas United States 67114
8 4016 - Heartland Research Associates, LLC - An AMR Company Wichita Kansas United States 67207
9 4001 - Central Kentucky Research Associates, an AMR company Lexington Kentucky United States 40509
10 4014 - Medpharmi Kenner Louisiana United States 70065
11 4008 - The Center for Pharmaceutical Research, an AMR company Kansas City Missouri United States 64114
12 4024 - Sundance Clinical Research, LLC Saint Louis Missouri United States 63141
13 4009 - Meridian Clinical Research, LLC Omaha Nebraska United States 68134
14 4007 - Regional Clinical Research / United Medical Associates Binghamton New York United States 13901
15 4012 - M3 Wake Research, Inc. Raleigh North Carolina United States 27612
16 4004 - Sterling research Cincinnati Ohio United States 45219
17 4017 - Rapid Medical Research, Inc. Cleveland Ohio United States 44122
18 4011 - Lynn Health Science Institute Oklahoma City Oklahoma United States 73112
19 4005 - Clinical Trials of Texas, Inc. San Antonio Texas United States 78229
20 4018 - Martin Diagnostic Clinic Tomball Texas United States 77375
21 4020 - Advanced Clinical Research West Jordan Utah United States 84088

Sponsors and Collaborators

  • Seqirus

Investigators

  • Study Director: Clinical Program Director, Seqirus

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Seqirus
ClinicalTrials.gov Identifier:
NCT04576702
Other Study ID Numbers:
  • V200_10
First Posted:
Oct 6, 2020
Last Update Posted:
Mar 17, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Seqirus
Influenza
Vaccine
MF59
Adjuvant
Additional relevant MeSH terms:
Influenza, Human

Study Results

No Results Posted as of Mar 17, 2022