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

Seqirus

Status and phase: Enrolling; Phase 1

Conditions: Influenza, Human; Infection Viral; Infections; Virus Diseases; Respiratory Tract Infections

Treatments: Biological: Lowest dose A/H2N3c + high dose MF59; Biological: Low dose A/H2N3c + standard dose MF59; Biological: Low dose A/H2N3c + high dose MF59; Biological: High dose A/H2N3c + standard dose MF59; Biological: High dose A/H2N3c non-adjuvanted; Biological: Intermediate dose A/H2N3c + standard dose MF59

Study type: Interventional

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT05875961

V204_01

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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600 participants in 6 patient groups

Group A

Experimental group

Description:

Eligible subjects who have been randomized to receive two intramuscular vaccinations (3 weeks apart) of low dose A/H2N3c + standard dose MF59 adjuvant

Treatment:

Biological: Low dose A/H2N3c + standard dose MF59

Group B

Experimental group

Description:

Eligible subjects who have been randomized to receive two intramuscular vaccinations (3 weeks apart) of intermediate dose A/H2N3c + standard dose MF59 adjuvant

Treatment:

Biological: Intermediate dose A/H2N3c + standard dose MF59

Group C

Experimental group

Description:

Eligible subjects who have been randomized to receive two intramuscular vaccinations (3 weeks apart) of high dose A/H2N3c + standard dose MF59 adjuvant

Treatment:

Biological: High dose A/H2N3c + standard dose MF59

Group D

Experimental group

Description:

Eligible subjects who have been randomized to receive two intramuscular vaccinations (3 weeks apart) of high dose A/H2N3c non-adjuvanted

Treatment:

Biological: High dose A/H2N3c non-adjuvanted

Group E

Experimental group

Description:

Eligible subjects who have been randomized to receive two intramuscular vaccinations (3 weeks apart) of lowest dose A/H2N3c + high dose MF59 adjuvant

Treatment:

Biological: Lowest dose A/H2N3c + high dose MF59

Group F

Experimental group

Description:

Eligible subjects who have been randomized to receive two intramuscular vaccinations (3 weeks apart) of low dose A/H2N3c + high dose MF59 adjuvant

Treatment:

Biological: Low dose A/H2N3c + high dose MF59