RECRUITING

A Study to Find and Confirm the Dose and Assess Safety, Reactogenicity and Immune Response of a Vaccine Against Pandemic H5N1 Influenza Virus in Healthy Younger and Older Adults

Conditions

Influenza, Human Influenza A virus Avian influenza Flu pandemic Healthy younger adults Healthy older adults Safety Reactogenicity Immunogenicity

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The aim of this study is to evaluate the safety, reactogenicity and immunogenicity of the Flu Pandemic messenger RNA (mRNA) vaccine (including dose-finding and dose-confirmation) administered in healthy adults 18 to 85 years of age.

Official Title

A PHASE 1/2, RANDOMIZED, PARTIALLY-BLIND, DOSE-FINDING/DOSE-CONFIRMATION STUDY TO EVALUATE THE SAFETY, REACTOGENICITY AND IMMUNOGENICITY OF THE MRNA-BASED INVESTIGATIONAL PANDEMIC H5 INFLUENZA VACCINE CANDIDATE ADMINISTERED IN HEALTHY YOUNGER AND OLDER ADULTS

Quick Facts

Study Start:2024-04-18

Study Completion:2026-01-16

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06382311

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* A male or female between and including 18 and 64 yoa (i.e., 64 years + 364 days; YAs) or between and including 65 and 85 yoa (i.e., 85 years + 364 days; OAs) at the time of the first study intervention administration. * 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). * Body mass index (BMI) more than or equal to (≥)18 kilogram per square meter (kg/m²) and less than or equal to (≤) 35kg/m². * Written informed consent obtained from the participant prior to performance of any study-specific procedure. * Healthy participants or medically stable patients as established by medical history, clinical examination, and screening safety laboratory assessments (Where applicable) 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 change in therapy or hospitalization for worsening disease during 3 months before enrollment. * Females of nonchildbearing potential may be enrolled in the study. * Females of childbearing potential may be enrolled in the study, if the participant: * has practiced adequate contraception for 1 month prior to study intervention administration, and * has a negative pregnancy test at Screening Visit (if applicable) and on the day of each study intervention administration, and * has agreed to continue adequate contraception for at least 1 month after completion of the last dose of study intervention.	* Where applicable, FDA toxicity grades will be exclusionary. * Planned administration of an influenza vaccine before Day 43 time point. * Current or past malignancy, unless completely resolved without clinically significant sequelae (e.g., no evidence of disease following successful treatment of basal cell carcinoma cases are allowed) for \>5 years. * Has any medical disease or psychiatric condition that, in the opinion of the investigator, precludes study participation because it would place the participant at an unacceptable risk of injury, would render them unable to meet the requirements of the protocol, or may interfere with successful completion of the study. * Has a bleeding disorder (e.g., factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following intramuscular (IM) injections. * Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection, based on medical history and physical examination (no laboratory testing required). However, in Phase 2, 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) (based on medical records, no laboratory testing required). * History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s) (including polyethylene glycol, aminoglycoside antibiotics and egg products). * History of uncontrolled neurological disorders or seizures, including Guillain-Barré syndrome and Bell's palsy, with the exception of febrile seizures during childhood. * Any history of dementia or any medical condition that moderately or severely impairs cognition. * 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 myocarditis or pericarditis, including cocaine abuse, cardiomyopathy, endomyocardial fibrosis, hypereosinophilic syndrome, hypersensitivity myocarditis, eosinophilic granulomatosis with polyangiitis and persistent myocardial infection. * Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study. * 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. * Administration of a vaccine not foreseen by the study protocol in the period starting 28 days before the study intervention administration or planned administration within 21 days after the (last) study intervention administration\. 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 3 months prior to the study intervention administration: * For corticosteroids, this will mean prednisone equivalent 20 mg/day. Inhaled, intra-articular and topical corticosteroids are allowed. If systemic corticosteroids have been administered short term (\<14 days) for treatment of an acute illness, participants should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 28 days before study vaccine administration. * Up to 3 months prior to study intervention administration: long-acting immune-modifying drugs including among others immunotherapy (e.g., TNF-inhibitors), monoclonal antibodies, antitumoral medication. * Administration of immunoglobulins and/or any blood products or plasma derivatives within 3 months before study intervention administration through end of study. * Concurrently 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 (drug/invasive medical device). * Participated in an A(H5) influenza vaccine study in the past or have a history of A(H5) influenza infection prior to dosing in this study. This includes influenza subtypes A(H5N1), A(H5N8), A(H5N6). * Pregnant or lactating female participant. * Female planning to become pregnant or planning to discontinue contraceptive precautions within 1 months after completion of the vaccination series. * Has a 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. * Any study personnel or their immediate dependents, family, or household members. * Participants with extensive tattoos covering deltoid region on both arms that would preclude the assessment of local reactogenicity. * Planned move during the study period that will prohibit participating in the study until study end. * Donation of blood 3 months prior to the study intervention administration and during the study period.

Inclusion Criteria

Exclusion Criteria

* A male or female between and including 18 and 64 yoa (i.e., 64 years + 364 days; YAs) or between and including 65 and 85 yoa (i.e., 85 years + 364 days; OAs) at the time of the first study intervention administration.
* 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).
* Body mass index (BMI) more than or equal to (≥)18 kilogram per square meter (kg/m²) and less than or equal to (≤) 35kg/m².
* Written informed consent obtained from the participant prior to performance of any study-specific procedure.
* Healthy participants or medically stable patients as established by medical history, clinical examination, and screening safety laboratory assessments (Where applicable) 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 change in therapy or hospitalization for worsening disease during 3 months before enrollment.
* Females of nonchildbearing potential may be enrolled in the study.
* Females of childbearing potential may be enrolled in the study, if the participant:
* has practiced adequate contraception for 1 month prior to study intervention administration, and
* has a negative pregnancy test at Screening Visit (if applicable) and on the day of each study intervention administration, and
* has agreed to continue adequate contraception for at least 1 month after completion of the last dose of study intervention.

* Where applicable, FDA toxicity grades will be exclusionary.
* Planned administration of an influenza vaccine before Day 43 time point.
* Current or past malignancy, unless completely resolved without clinically significant sequelae (e.g., no evidence of disease following successful treatment of basal cell carcinoma cases are allowed) for \>5 years.
* Has any medical disease or psychiatric condition that, in the opinion of the investigator, precludes study participation because it would place the participant at an unacceptable risk of injury, would render them unable to meet the requirements of the protocol, or may interfere with successful completion of the study.
* Has a bleeding disorder (e.g., factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following intramuscular (IM) injections.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection, based on medical history and physical examination (no laboratory testing required). However, in Phase 2, 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) (based on medical records, no laboratory testing required).
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s) (including polyethylene glycol, aminoglycoside antibiotics and egg products).
* History of uncontrolled neurological disorders or seizures, including Guillain-Barré syndrome and Bell's palsy, with the exception of febrile seizures during childhood.
* Any history of dementia or any medical condition that moderately or severely impairs cognition.
* 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 myocarditis or pericarditis, including cocaine abuse, cardiomyopathy, endomyocardial fibrosis, hypereosinophilic syndrome, hypersensitivity myocarditis, eosinophilic granulomatosis with polyangiitis and persistent myocardial infection.
* Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
* 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.
* Administration of a vaccine not foreseen by the study protocol in the period starting 28 days before the study intervention administration or planned administration within 21 days after the (last) study intervention administration\*.
* 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 3 months prior to the study intervention administration:
* For corticosteroids, this will mean prednisone equivalent 20 mg/day. Inhaled, intra-articular and topical corticosteroids are allowed. If systemic corticosteroids have been administered short term (\<14 days) for treatment of an acute illness, participants should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 28 days before study vaccine administration.
* Up to 3 months prior to study intervention administration: long-acting immune-modifying drugs including among others immunotherapy (e.g., TNF-inhibitors), monoclonal antibodies, antitumoral medication.
* Administration of immunoglobulins and/or any blood products or plasma derivatives within 3 months before study intervention administration through end of study.
* Concurrently 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 (drug/invasive medical device).
* Participated in an A(H5) influenza vaccine study in the past or have a history of A(H5) influenza infection prior to dosing in this study. This includes influenza subtypes A(H5N1), A(H5N8), A(H5N6).
* Pregnant or lactating female participant.
* Female planning to become pregnant or planning to discontinue contraceptive precautions within 1 months after completion of the vaccination series.
* Has a 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.
* Any study personnel or their immediate dependents, family, or household members.
* Participants with extensive tattoos covering deltoid region on both arms that would preclude the assessment of local reactogenicity.
* Planned move during the study period that will prohibit participating in the study until study end.
* Donation of blood 3 months prior to the study intervention administration and during the study period.

Contacts and Locations

Study Contact

US GSK Clinical Trials Call Center

CONTACT

877-379-3718

GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466

GSKClinicalSupportHD@gsk.com

Study Locations (Sites)

GSK Investigational Site

Anniston, Alabama, 36207

United States

GSK Investigational Site

Little Rock, Arkansas, 72204

United States

GSK Investigational Site

Fort Collins, Colorado, 80525

United States

GSK Investigational Site

Fort Myers, Florida, 33912

United States

GSK Investigational Site

West Palm Beach, Florida, 33409

United States

GSK Investigational Site

Chamblee, Georgia, 30043

United States

GSK Investigational Site

El Dorado, Kansas, 67042

United States

GSK Investigational Site

Lenexa, Kansas, 66219

United States

GSK Investigational Site

Lexington, Kentucky, 40509

United States

GSK Investigational Site

Kansas City, Missouri, 64114

United States

GSK Investigational Site

Omaha, Nebraska, 68144

United States

GSK Investigational Site

Las Vegas, Nevada, 89102

United States

GSK Investigational Site

Rochester, New York, 14609

United States

GSK Investigational Site

Greensboro, North Carolina, 27405

United States

GSK Investigational Site

Winston-Salem, North Carolina, 27103

United States

GSK Investigational Site

Edmond, Oklahoma, 73013

United States

GSK Investigational Site

Yukon, Oklahoma, 73099

United States

GSK Investigational Site

Philadelphia, Pennsylvania, 19111

United States

GSK Investigational Site

Austin, Texas, 78705

United States

GSK Investigational Site

Norfolk, Virginia, 23502

United States

GSK Investigational Site

Seattle, Washington, 98104

United States

Collaborators and Investigators

Sponsor: GlaxoSmithKline

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-18

Study Completion Date2026-01-16

Study Record Updates

Study Start Date2024-04-18

Study Completion Date2026-01-16

Terms related to this study

Keywords Provided by Researchers

Influenza A virus
Avian influenza
Flu pandemic
Healthy younger adults
Healthy older adults
Safety
Reactogenicity
Immunogenicity

Additional Relevant MeSH Terms

Influenza, Human