A phase 3 randomized, observer-blind, controlled study to evaluate the clinical efficacy of an mRNA- based seasonal influenza vaccine in older adults ≥65 years of age
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- GlaxoSmithKline Biologicals
- Enrollment
- 12,000
- Locations
- 47
- Primary Endpoint
- Occurrence of SAEs and AESIs up to the end of the corresponding influenza season (with at least 180 days of follow-up)
Study Overview
Brief Summary
To demonstrate the non-inferiority of the investigational study intervention in terms of relative efficacy as compared to the active comparator against laboratory-confirmed protocol-defined ILI caused by influenza subtypes/lineages contained in the investigational study intervention.
To evaluate the safety and reactogenicity of the study interventions
Eligibility Criteria
- Ages
- 65 years to 65+ years (65+ Years)
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiary, return for follow-up visits, attendance to study contacts, ability to access and utilize a phone or other electronic communications and collection of nasal self-swabs) independently or with the assistance of a caregiver.
- •Written or witnessed (physically or digitally) informed consent obtained from the participant/LAR(s) of the participant prior to performance of any study-specific procedure.
- •Healthy participants or medically stable patients as established by medical history and clinical examination. Participants with chronic medical conditions with or without specific treatment (e.g., chronic metabolic, cardiac, pulmonary, renal, hepatic, neurologic, and hematologic diseases) are allowed to participate in this study if considered by the investigator as medically stable. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during 3 months before enrollment.
- •A male participant or a female participant of non-childbearing potential at least 65 YOA at the time of the study intervention administration.
Exclusion Criteria
- •History of test-confirmed influenza infection within 180 days prior to study intervention administration.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). HIV-infected individuals may be enrolled if they have been stable on antiretroviral therapy for the past 6 consecutive months, i.e., their treatment has not been modified, their CD4 cell count is ≥ 200/mm³ and their viral load has been undetectable (i.e., HIV-RNA < 50 copies/mL).
- •History of myocarditis or pericarditis considered causally associated with the administration of an mRNA vaccine.
- •Acute or unstable chronic conditions [clinically significant pulmonary, cardiovascular, hepatic, metabolic/endocrine disorders, renal functional abnormality, or psychiatric conditions], as determined by medical history and clinical examination.
- •Administration of an influenza vaccine in the period starting 180 days before the study intervention administration or planned administration at any time during the study.
- •Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or planned use of long-acting immune-modifying treatments at any time up to the end of the study. Up to 90 days prior to the study intervention administration: o For systemic corticosteroids: prednisone equivalent ≥20 mg/day for >14 days. Inhaled, intra articular/intra-bursal, and topical steroids are allowed. o Long-acting immune-modifying drugs including among others immunotherapy (e.g., TNF-inhibitors), monoclonal antibodies, antitumoral medication.
- •For further exclusion criteria, kindly refer to the protocol (Section 5.2)
Arms & Interventions
Efluelda TIV-HD, suspension for injection in pre-filled syringe Trivalent influenza vaccine (split virion, inactivated), 60 micrograms HA/strain
Intervention: Efluelda TIV-HD, suspension for injection in pre-filled syringe Trivalent influenza vaccine (split virion, inactivated), 60 micrograms HA/strain (Drug)
Outcomes
Primary Outcomes
Occurrence of SAEs and AESIs up to the end of the corresponding influenza season (with at least 180 days of follow-up)
Occurrence of SAEs and AESIs up to the end of the corresponding influenza season (with at least 180 days of follow-up)
For additional primary end points, kindly refer to the protocol (Section 3)
For additional primary end points, kindly refer to the protocol (Section 3)
First occurrence, at least 14 days after dosing, of laboratory-confirmed cases of protocol-defined ILI caused by influenza A subtypes H1N1 or H3N2 or influenza B/Victoria
First occurrence, at least 14 days after dosing, of laboratory-confirmed cases of protocol-defined ILI caused by influenza A subtypes H1N1 or H3N2 or influenza B/Victoria
Occurrence of any solicited administration site and systemic events during the 7 days (including the day of study intervention administration) following study intervention administration (Day 1 to Day 7)
Occurrence of any solicited administration site and systemic events during the 7 days (including the day of study intervention administration) following study intervention administration (Day 1 to Day 7)
Occurrence of unsolicited AEs during the 28 days (including the day of study intervention administration) following study intervention administration (Day 1 to Day 28)
Occurrence of unsolicited AEs during the 28 days (including the day of study intervention administration) following study intervention administration (Day 1 to Day 28)
Secondary Outcomes
- First occurrence, at least 14 days after dosing, of laboratory-confirmed cases of protocol-defined ILI, caused by influenza A subtypes H1N1 or H3N2 or influenza B/Victoria
- First occurrence, at least 14 days after dosing, of cases of SID caused by influenza A or B
Investigators
EU GSK Clinical Trials Call Center
Scientific
GlaxoSmithKline Biologicals