Study to Evaluate Immunogenicity, Safety and Tolerability of Adjuvanted and Non-Adjuvanted H2N3 Influenza Vaccines in Adults

NCT05875961
clinicaltrials.gov
Phase
Phase 1
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Recruitment status
Completed
clinicaltrials.gov
Participants
600
clinicaltrials.gov
Lead sponsor
Seqirus
clinicaltrials.gov
Start date
2023-06-15
clinicaltrials.gov
Number of sites
7
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Summary
This Phase 1, randomized, observer-blind, dose-ranging clinical study is evaluating 6 different formulations of MF59-adjuvanted and non-adjuvanted H2N3 influenza vaccine. Approximately 600 healthy adult subjects are to be randomized into 1 of 6 possible treatment groups with 100 subjects per group, stratified by age group (born after or before 1968). Each subject will receive an influenza vaccine injection on Day 1 and Day 22. Subjects will be followed up for approximately 12 months after the second vaccine injection. The primary immunogenicity analysis is based on the Day 1, Day 8, Day 22, Day 29, and Day 43 serology data. The primary safety analysis is based on solicited local and systemic adverse events (AEs) reported within 10 days after each vaccination, unsolicited AEs reported within 3 weeks after each vaccination, and serious AEs (SAEs), medically attended AEs (MAAEs), AEs leading to withdrawal from the study, and AEs of special interest (AESIs) reported throughout the study.
clinicaltrials.gov
Short title
Study to Evaluate Immunogenicity, Safety and Tolerability of Adjuvanted and Non-Adjuvanted H2N3 Influenza Vaccines in Adults
clinicaltrials.gov
Official title
A Phase 1, Randomized, Observer-Blind, Multi-Center, Dose Ranging Study to Evaluate the Immunogenicity, Safety and Tolerability of Different Formulations of an Adjuvanted or Non-Adjuvanted Cell Culture-derived A/H2N3 Subunit Influenza Virus Vaccine in Healthy Subjects 18 Years and Above
clinicaltrials.gov

Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Completed
clinicaltrials.gov
Phase
Phase 1
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Study type
Interventional
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Completion date
2024-11-15
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First posted
2023-05-25
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Registry last updated
2025-01-22
clinicaltrials.gov
Primary completion date
2024-11-15
clinicaltrials.gov
Start date
2023-06-15
clinicaltrials.gov

Actual participants
600
clinicaltrials.gov
Participants
600
clinicaltrials.gov
Participant count basis
Actual
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Protocol amendments
3
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Number of sites
7
clinicaltrials.gov

Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Seqirus
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Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT05875961
clinicaltrials.gov
ClinicalTrials.gov ID
NCT05875961
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Randomised
Model
Parallel groups
Purpose
Prevention
Masking
Triple masking
Masked roles
Participants, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Geometric mean titer (GMT) of hemagglutination inhibition (HI) antibodies against homologous H2N3 strain - Day 1

    Timeframe: Day 1

    GMT (HI) prevaccination

  2. GMT of HI antibodies against homologous H2N3 strain - Day 8

    Timeframe: Day 8

    GMT (HI) 1 week postvaccination 1

  3. GMT of HI antibodies against homologous H2N3 strain Day 22

    Timeframe: Day 22

    GMT (HI) 3 weeks postvaccination 1

  4. GMT of HI antibodies against homologous H2N3 strain - Day 29

    Timeframe: Day 29

    GMT (HI) 1 week postvaccination 2

  5. GMT of HI antibodies against homologous H2N3 strain - Day 43

    Timeframe: Day 43

    GMT (HI) 3 weeks postvaccination 2

  6. GMT of microneutralization (MN) antibodies against homologous H2N3 strain - Day 1

    Timeframe: Day 1

    GMT (MN) prevaccination

  7. GMT of MN antibodies against homologous H2N3 strain - Day 8

    Timeframe: Day 8

    GMT (MN) 1 week postvaccination 1

  8. GMT of MN antibodies against homologous H2N3 strain - Day 22

    Timeframe: Day 22

    GMT (MN) 3 weeks postvaccination 1

  9. GMT of MN antibodies against homologous H2N3 strain - Day 29

    Timeframe: Day 29

    GMT (MN) 1 week postvaccination 2

  10. GMT of MN antibodies against homologous H2N3 strain - Day 43

    Timeframe: Day 43

    GMT (MN) 3 weeks postvaccination 2

  11. Geometric mean fold increase (GMFI) of HI antibodies against homologous H2N3 strain - Day 8

    Timeframe: Day 8

    GMFI (HI) 1 week postvaccination 1 compared to prevaccination

  12. GMFI of HI antibodies against homologous H2N3 strain - Day 22

    Timeframe: Day 22

    GMFI (HI) 3 weeks postvaccination 1 compared to prevaccination

  13. GMFI of HI antibodies against homologous H2N3 strain - Day 29

    Timeframe: Day 29

    GMFI (HI) 1 week postvaccination 2 compared to prevaccination

  14. GMFI of HI antibodies against homologous H2N3 strain - Day 43

    Timeframe: Day 43

    GMFI (HI) 3 weeks postvaccination 2 compared to prevaccination

  15. GMFI of MN antibodies against homologous H2N3 strain - Day 8

    Timeframe: Day 8

    GMFI (MN) 1 week postvaccination 1 compared to prevaccination

  16. GMFI of MN antibodies against homologous H2N3 strain - Day 22

    Timeframe: Day 22

    GMFI (MN) 3 weeks postvaccination 1 compared to prevaccination

  17. GMFI of MN antibodies against homologous H2N3 strain - Day 29

    Timeframe: Day 29

    GMFI (MN) 1 week postvaccination 2 compared to prevaccination

  18. GMFI of MN antibodies against homologous H2N3 strain - Day 43

    Timeframe: Day 43

    GMFI (MN) 3 weeks postvaccination 2 compared to prevaccination

  19. Percentages of subjects with HI titers ≥1:40 against homologous H2N3 strain - Day 1

    Timeframe: Day 1

    % ≥1:40 (HI) prevaccination

  20. Percentages of subjects with HI titers ≥1:40 against homologous H2N3 strain - Day 8

    Timeframe: Day 8

    % ≥1:40 (HI) 1 week postvaccination 1

  21. Percentages of subjects with HI titers ≥1:40 against homologous H2N3 strain - Day 22

    Timeframe: Day 22

    % ≥1:40 (HI) 3 weeks postvaccination 1

  22. Percentages of subjects with HI titers ≥1:40 against homologous H2N3 strain - Day 29

    Timeframe: Day 29

    % ≥1:40 (HI) 1 week postvaccination 2

  23. Percentages of subjects with HI titers ≥1:40 against homologous H2N3 strain - Day 43

    Timeframe: Day 43

    % ≥1:40 (HI) 3 weeks postvaccination 2

  24. Percentages of subjects with MN titers ≥1:40 against homologous H2N3 strain - Day 1

    Timeframe: Day 1

    % ≥1:40 (MN) prevaccination

  25. Percentages of subjects with MN titers ≥1:40 against homologous H2N3 strain - Day 8

    Timeframe: Day 8

    % ≥1:40 (MN) 1 week postvaccination 1

And 15 more, listed on the interactive page.

  1. GMT of ELLA titers as a measure of anti-neuraminidase (NA) immunogenicity

    Timeframe: Day 1, Day 8, Day 22, Day 29, Day 43

    GMT (ELLA) prevaccination, 1 and 3 weeks postvaccination

  2. GMFI of ELLA titers as a measure of anti-NA immunogenicity

    Timeframe: Day 8, Day 22, Day 29, Day 43

    GMFI (ELLA) 1 and 3 weeks postvaccination compared to prevaccination

  3. Percentage of subjects with ≥4-fold increase in ELLA titer as a measure of anti-NA immunogenicity

    Timeframe: Day 8, Day 22, Day 29, Day 43

    % ≥4-fold increase (ELLA) 1 and 3 weeks postvaccination compared to prevaccination

  4. GMT of HI antibodies against homologous H2N3 strain - Persistence

    Timeframe: Day 202, Day 387

    GMT (HI) 6 and 12 months postvaccination 2

  5. GMT of MN antibodies against homologous H2N3 strain - Persistence

    Timeframe: Day 202, Day 387

    GMT (MN) 6 and 12 months postvaccination 2

  6. GMT of ELLA titer as a measure of anti-NA immunogenicity- Persistence

    Timeframe: Day 202, Day 387

    GMT (ELLA) 6 and 12 months postvaccination 2

  7. GMFI of HI antibodies against homologous H2N3 strain - Persistence

    Timeframe: Day 202, Day 387

    GMFI (HI) 6 and 12 months postvaccination 2 compared to prevaccination

  8. GMFI of MN antibodies against homologous H2N3 strain - Persistence

    Timeframe: Day 202, Day 387

    GMFI (MN) 6 and 12 months postvaccination 2 compared to prevaccination

  9. GMFI of ELLA titer as a measure of anti-NA immunogenicity- Persistence

    Timeframe: Day 202, Day 387

    GMFI (ELLA) 6 and 12 months postvaccination 2 compared to prevaccination

  10. Percentages of subjects with HI titers ≥1:40 against homologous H2N3 strain - Persistence

    Timeframe: Day 202, Day 387

    % ≥1:40 (HI) 6 and 12 months postvaccination 2

  11. Percentages of subjects with MN titers ≥1:40, ≥1:80 and ≥1:160 against homologous H2N3 strain - Persistence

    Timeframe: Day 202, Day 387

    % ≥1:40, ≥1:80 and ≥1:160 (MN) 6 and 12 months postvaccination 2

  12. Percentages of subjects with seroconversion by HI against homologous H2N3 strain - Persistence

    Timeframe: Day 202, Day 387

    % seroconversion (HI) 6 and 12 months postvaccination 2, defined as a ≥4-fold increase in HI titer postvaccination in those with prevaccination titer ≥1:10, or a postvaccination HI titer ≥1:40 for subjects with baseline titer \<1:10

  13. Percentages of subjects with seroconversion by MN against homologous H2N3 strain - Persistence

    Timeframe: Day 202, Day 387

    % seroconversion (MN) 6 and 12 months postvaccination 2, defined as a ≥4-fold increase in MN titer postvaccination in those with prevaccination titer ≥LLOQ, or a postvaccination MN titer ≥4×LLOQ for subjects with baseline titer \<LLOQ

  14. Percentage of subjects with ≥4-fold increase in ELLA titer as a measure of anti-NA immunogenicity - Persistence

    Timeframe: Day 202, Day 387

    % ≥4-fold increase (ELLA) 6 and 12 months postvaccination 2 compared to prevaccination

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
Yes

  • Individuals of 18 years of age and older on the day of informed consent who were not born in 1968.
  • Individuals who have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
  • Individuals who can comply with study procedures including follow-up.
  • 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 last study vaccination.

  • 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 study entry and who do not plan to do so until 2 months after the last study vaccination.

  • A body mass index (BMI) ≥35 kg/m2.

  • Progressive, unstable, or uncontrolled clinical conditions as per investigator's assessment. Subjects must be stable and unchanged for a minimum of 3 months.

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

  • Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.

  • Abnormal function of the immune system resulting from:

    1. Clinical conditions.
    2. Systemic administration of corticosteroids at a dose of ≥20 mg/day of prednisone or equivalent for more than 14 consecutive days within 90 days prior to informed consent. Topical, inhaled and intranasal corticosteroids are permitted. Intermittent use (one dose in 30 days) of intra-articular corticosteroids are also permitted.
    3. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent.

  • History of any medical condition considered an adverse event of special interest (AESI).

  • Received immunoglobulins with immunomodulating effects or any blood products within 180 days prior to informed consent.

  • Received an investigational or non-registered medicinal product within 30 days prior to informed consent.

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

  • 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.

  • Individuals who received any other vaccines (with the exception of COVID-19 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.

  • Receipt of any (investigational or licensed) COVID-19 vaccine within 14 days (non-replicating vaccines) or 28 days (replicating vaccines) prior to enrollment or plan to receive any COVID-19 vaccine within 14 days from study vaccination.

  • A known history of Guillain-Barre Syndrome or other demyelinating diseases such as encephalomyelitis and transverse myelitis.

Sources for eligibility
clinicaltrials.gov

  • Meridian Clinical ResearchRockville, United States
  • Meridian Clinical ResearchLincoln, United States
  • Meridian Clinical ResearchOmaha, United States
  • West Visayas State University Medical CenterIloilo City, Philippines
  • Manila Doctors HospitalManila, Philippines
  • Quirino Memorial Medical CenterQuezon City, Philippines
  • Silang Specialists Medical CenterSilang, Philippines
Sources for sites
clinicaltrials.gov

Related records

Drugs (4)

Collaborators (1)

Lead sponsors (1)

Conditions (3)

Targets (4)