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

Last updated: January 21, 2025
Sponsor: Seqirus
Overall Status: Completed

Phase

1

Condition

Respiratory Syncytial Virus (Rsv) Infection

Treatment

High dose A/H2N3c + standard dose MF59

Low dose A/H2N3c + high dose MF59

Low dose A/H2N3c + standard dose MF59

Clinical Study ID

NCT05875961
V204_01
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Individuals of 18 years of age and older on the day of informed consent who were notborn in 1968.

  • Individuals who have voluntarily given written informed consent after the nature ofthe study has been explained according to local regulatory requirements, prior tostudy entry.

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

  • Males, females of non-childbearing potential or females of childbearing potentialwho are using an effective birth control method, at least 30 days prior to informedconsent, which they intend to use for at least 2 months after the last studyvaccination.

Exclusion

Exclusion Criteria:

  • Females of childbearing potential who are pregnant, lactating, or who have notadhered to a specified set of contraceptive methods from at least 30 days prior tostudy entry and who do not plan to do so until 2 months after the last studyvaccination.

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

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

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

  • Clinical conditions representing a contraindication to intramuscular vaccination andblood draws.

  • Abnormal function of the immune system resulting from:

  1. Clinical conditions.

  2. Systemic administration of corticosteroids at a dose of ≥20 mg/day ofprednisone or equivalent for more than 14 consecutive days within 90 days priorto informed consent. Topical, inhaled and intranasal corticosteroids arepermitted. Intermittent use (one dose in 30 days) of intra-articularcorticosteroids are also permitted.

  3. Administration of antineoplastic and immunomodulating agents or radiotherapywithin 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 priorto informed consent.

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

  • Any other clinical condition that, in the opinion of the investigator, mightinterfere with the results of the study or pose additional risk to the subject dueto participation in the study.

  • Individuals who received any other vaccines (with the exception of COVID-19vaccines) 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 orplan to receive any COVID-19 vaccine within 14 days from study vaccination.

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

Study Design

Total Participants: 600
Treatment Group(s): 6
Primary Treatment: High dose A/H2N3c + standard dose MF59
Phase: 1
Study Start date:
June 15, 2023
Estimated Completion Date:
November 15, 2024

Connect with a study center

  • De La Salle Medical and Health Sciences Institute

    Dasmariñas, Cavite 4114
    Philippines

    Site Not Available

  • West Visayas State University Medical Center

    Iloilo City,
    Philippines

    Site Not Available

  • Manila Doctors Hospital

    Manila,
    Philippines

    Site Not Available

  • Quirino Memorial Medical Center

    Quezon City,
    Philippines

    Site Not Available

  • Silang Specialists Medical Center

    Silang,
    Philippines

    Site Not Available

  • Meridian Clinical Research

    Rockville, Maryland 20854
    United States

    Site Not Available

  • Meridian Clinical Research

    Lincoln, Nebraska 68510
    United States

    Site Not Available

  • Meridian Clinical Research

    Omaha, Nebraska 58134
    United States

    Site Not Available

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