GSKVX000000034798, GSKVX000000048110, GSKVX000000048111, GSKVX000000070248, GSKVX000000070250, GSKVX000000070965 for Influenza (human)

Inclusion criteria

• {"criterion_text":"- Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiary, attendance to study contacts and study site visits, and ability to access and utilize a phone or other electronic communications) independently or with the assistance of a caregiver."}
• {"criterion_text":"- Written (physically, or digitally) informed consent obtained from the participant prior to performance of any study-specific procedure."}
• {"criterion_text":"- A male or female at least 18 YOA at the time of the screening (except for certain states in the US, where only adults as per local regulations will be eligible)."}
• {"criterion_text":"- 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, 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."}
• {"criterion_text":"- Female participants of non-childbearing potential may be enrolled in the clinical study."}
• {"criterion_text":"- Female participants of childbearing potential may be enrolled in the clinical study, if the participant: o\tHas practiced adequate contraception for at least 4 weeks prior to the study intervention administration, and o\tHas a negative urine pregnancy test within 24 hours prior to the study intervention administration, and o\tHas agreed to continue adequate contraception for at least 8 weeks after study intervention administration."}
• {"criterion_text":"- Body mass index (BMI) ≥18 kg/m² and ≤33 kg/m²."}

Exclusion criteria

• {"criterion_text":"- Where applicable, FDA toxicity grades will be exclusionary."}
• {"criterion_text":"- History of or current suspicion of myocarditis or pericarditis (including following administration of an mRNA vaccine); or idiopathic cardiomyopathy, or presence of any medical condition that increases the risk of myocarditis or pericarditis, including cocaine abuse, cardiomyopathy, endomyocardial fibrosis, Hyper Eosinophilic Syndrome (HES), hypersensitivity myocarditis, eosinophilic granulomatosis with polyangiitis and persistent myocardial infection."}
• {"criterion_text":"- Condition that in the judgment of the investigator would make intramuscular injection unsafe."}
• {"criterion_text":"- Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the clinical study."}
• {"criterion_text":"- History of confirmed influenza infection by local health authority-approved testing methods within 180 days prior to study intervention administration."}
• {"criterion_text":"- Use of any investigational or non-registered product (drug, vaccine or invasive medical device) other than the study intervention(s) during the period beginning 28 days before the dose of study intervention(s) (Day -28 to Day 1), or their planned use during the study period."}
• {"criterion_text":"- Administration of an influenza vaccine within 180 days before the study intervention administration or planned administration prior to Visit 4 (Day 29) during the study."}
• {"criterion_text":"- Administration of any non-live attenuated non-study vaccine in the period starting 14 days before the study intervention administration, or planned administration within 14 days after study intervention administration."}
• {"criterion_text":"- Administration of any live attenuated and/or mRNA non-study non-influenza vaccine in the period starting 28 days before the study intervention administration, or planned administration within 28 days after study intervention administration."}
• {"criterion_text":"- 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. o\tUp to 90 days prior to the study intervention administration: For systemic corticosteroids, this will mean prednisone equivalent ≥20 mg/day for adult participants for >14 days. Inhaled, intra-articular/intra-bursal, and topical corticosteroids are allowed. o\tUp to 90 days prior to the study intervention administration: Long-acting immune-modifying drugs including among others immunotherapy (e.g., TNF-inhibitors), monoclonal antibodies, antitumoral medication."}
• {"criterion_text":"- Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the study intervention, or planned administration during the study period."}
• {"criterion_text":"- Current or chronic conditions related with EXC#1"}
• {"criterion_text":"- Administration of antitumoral medication during the period starting 90 days before the study intervention or planned administration during the study period."}
• {"criterion_text":"- Concurrrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention."}
• {"criterion_text":"- Any study personnel or their immediate dependents, family, or household members."}
• {"criterion_text":"- History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures."}
• {"criterion_text":"- Participant is pregnant."}
• {"criterion_text":"- Participant is breastfeeding or will (re)start breastfeeding during the study."}
• {"criterion_text":"- 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)."}
• {"criterion_text":"- History of Guillain-Barré Syndrome within 6 weeks of receiving any vaccine."}
• {"criterion_text":"- Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study (e.g., life-threatening disease likely to limit survival to less than 1 year)."}
• {"criterion_text":"- Hypersensitivity to latex."}
• {"criterion_text":"- History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions."}
• {"criterion_text":"- History of hypersensitivity or allergic reaction to any previous influenza vaccine."}
• {"criterion_text":"- History of hypersensitivity or allergic reaction to any previous mRNA vaccine."}

Primary endpoints

• {"endpoint_text":"- Antigen 1 antibody titer at Day 29","definition_or_measurement_approach":"Antibody titer measured at Day 29 (humoral immune response assay)."}
• {"endpoint_text":"- Fold increase in antigen 1 antibody titer from Day 1 to Day 29","definition_or_measurement_approach":"Fold change calculation comparing Day 1 (pre-dose) to Day 29 (post-dose) antibody titers."}
• {"endpoint_text":"- Antigen 1 antibody seroconversion from Day 1 to Day 29","definition_or_measurement_approach":"Seroconversion from Day 1 to Day 29 as measured by defined increase in antibody titer (per study immunogenicity assay; specific seroconversion definition not provided in dataset)."}
• {"endpoint_text":"- Antigen 1 antibody seroprotection at Day 1 and Day 29","definition_or_measurement_approach":"Seroprotection status measured at Day 1 and Day 29 by antibody titer threshold (specific threshold not provided in dataset)."}
• {"endpoint_text":"- Occurrence of solicited administration site or systemic events with onset within 7 days of study intervention","definition_or_measurement_approach":"Solicited local and systemic reactogenicity events reported within 7 days post-vaccination (collected via eDiary/subject questionnaires)."}
• {"endpoint_text":"- Occurrence of unsolicited AEs within 28 days of study intervention","definition_or_measurement_approach":"Unsolicited adverse events collected through Day 28 post-vaccination."}
• {"endpoint_text":"- Occurrence of SAEs within 6 months of study intervention","definition_or_measurement_approach":"Serious adverse events monitored and recorded up to 6 months post-vaccination."}
• {"endpoint_text":"- Occurrence of AESIs within 6 months of study intervention","definition_or_measurement_approach":"Adverse events of special interest assessed up to 6 months post-vaccination."}
• {"endpoint_text":"- Occurrence of MAAEs within 6 months of study intervention","definition_or_measurement_approach":"Medically attended adverse events assessed up to 6 months post-vaccination."}
• {"endpoint_text":"- Occurrence of any laboratory abnormalities pre-dose (Day 1), post-Dose (Day 3, Day 8, Day 29)","definition_or_measurement_approach":"Laboratory safety assessments at Day 1 (pre-dose) and post-dose on Days 3, 8 and 29; abnormalities recorded per laboratory reference ranges."}

Secondary endpoints

• {"endpoint_text":"- Antigen 2 antibody titer at Day 29","definition_or_measurement_approach":"Antibody titer for antigen 2 measured at Day 29."}
• {"endpoint_text":"- Fold increase in antigen 2 antibody titer from Day 1 to Day 29","definition_or_measurement_approach":"Fold change from Day 1 to Day 29 antibody titers for antigen 2."}
• {"endpoint_text":"- Antigen 2 antibody seroconversion from Day 1 to Day 29","definition_or_measurement_approach":"Seroconversion for antigen 2 from Day 1 to Day 29 as measured by immunogenicity assay (specific seroconversion criteria not provided)."}

Methods

• Site-based recruitment at clinical sites (Universitair Ziekenhuis Gent; University Of Antwerp) — local site contact details provided for Belgium.
• Website text (K2_Website text_CEVAC; K2_Website text pre-screening_CEV) — online recruitment information for potential participants.
• Social media advertising/materials (K2_Social Media_CEV, K2_Social Media_CEVAC).
• Mail recruitment and prescreening questionnaires (K2_Recruitment Mail_CEV, K2_Mail prescreening questionnaire_CEVAC, K2_Prescreening questionnaire_CEVAC).
• Flyers and posters (K2_Flyer text_CEVAC; K2_Poster_CEV; K2_Advertisement_CEV).
• Vaxxis reminder e-mails for screening and follow-up (K2_Vaxxis remindermail screening_CEVAC; K2_Vaxxis remindermail V1D1_CEVAC; V2D3; V3D8; V4D29; V5D181).
• Prescreening forms and procedures (K2_Generic prescreening form_CEVAC; K2_Prescreening questionnaire_CEVAC; K1_Recruitment procedure_CEV_Redacted).

Belgium

Earliest CTIS Part Ii Submission Date

07-10-2025

Latest Decision Or Authorization Date

13-10-2025

Processing Time Days

6

Number Of Sites

2

Number Of Participants

168

Primary sponsor

Full Name

GlaxoSmithKline Biologicals

Organisation Type

Pharmaceutical company

Country Of Registered Address

Belgium

Contract research organisations

Name

Medable Inc.

Responsibilities

Digital platform/app provider for eConsent/eDiary/remote data capture (contact email: sophia.goldstein@medable.com); sponsorDuties code: 7

Name

PPD Global Central Labs

Responsibilities

Central laboratory services (sponsorDuties code: 4)

Name

Q Squared Solutions LLC

Responsibilities

Laboratory/testing services (sponsorDuties code: 4)

Name

WCG Clinical Inc.

Responsibilities

Regulatory/ethics support and meetings coordination (sponsorDuties codes: 13; 15 - Investigator's meeting and Monitor's meeting organization)

Name

Syneos Health Ba Limited

Responsibilities

Clinical operations support (sponsorDuties code: 6)

Third parties

• {"country":"United States","full_name":"Medable Inc.","duties_or_roles":"sponsorDuties codes: 7","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Q Squared Solutions LLC","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"sponsorDuties codes: 13 and 15 (15: Investigator's meeting and Monitor's meeting organization)","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"Alsinova Belgium","duties_or_roles":"sponsorDuties codes: 10","organisation_type":"Pharmaceutical company"}
• {"country":"Italy","full_name":"Vismederi S.r.l.","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United Kingdom","full_name":"Syneos Health Ba Limited","duties_or_roles":"sponsorDuties codes: 6","organisation_type":"Pharmaceutical company"}