Last updated: 07/01/2025 15:20:10
A study to assess the safety and immune response of a vaccine against influenza in healthy younger and older adults
EudraCT ID
Not applicable
EU CT Number
Trial status
Study complete
Study complete
Trial overview
Official title: A Phase 1/2, randomized, dose-finding/dose-confirmation study to evaluate the reactogenicity, safety and immunogenicity of mRNA-based multivalent seasonal influenza vaccine candidates administered in healthy younger and older adults
Trial description: The purpose of this study is to find and confirm the dose and asses the reactogenicity, safety and immune response of GlaxoSmithKline’s (GSK) messenger RNA (mRNA)-based multivalent seasonal influenza vaccine (GSK4382276A) candidates administered in healthy younger and older adults (OA).
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Number of participants reporting any solicited administration site adverse events (AEs)
Timeframe: Day 1 to Day 7
Number of participants reporting any solicited systemic AEs
Timeframe: Day 1 to Day 7
Number of participants reporting any unsolicited AEs
Timeframe: Day 1 to Day 28
Number of participants reporting serious adverse events (SAEs)
Timeframe: Day 1 to Day 183
Number of participants reporting AEs of special interest (AESIs)
Timeframe: Day 1 to Day 183
Number of participants reporting medically attended events (MAEs)
Timeframe: Day 1 to Day 183
Number of participants reporting a shift from abnormal non-clinically significant and normal or missing laboratory value on Day 1 to clinically significant abnormal laboratory value on Day 8 for hematology, and clinical chemistry
Timeframe: At Day 8 compared to baseline (Day 1)
Number of participants reporting a shift from abnormal non-clinically significant and normal or missing laboratory value on Day 1 to clinically significant abnormal laboratory value on Day 29 for hematology, and clinical chemistry
Timeframe: At Day 29 compared to baseline (Day 1)
Geometric mean titer (GMT) of antigen 1 antibody titer
Timeframe: At Day 29
Geometric mean increase (GMI) of antigen 1 antibody titers from Day 1 to Day 29
Timeframe: From Day 1 (baseline) to Day 29
Percentage of participants with antigen 1 antibody seroconversion rate (SCR)
Timeframe: From Day 1 to Day 29
Percentage of participants with antigen 1 antibody seroprotection rate (SPR)
Timeframe: At Day 1
Percentage of participants with antigen 1 antibody SPR
Timeframe: At Day 29
GMT of antigen 2 antibody titer
Timeframe: At Day 29
GMI of antigen 2 antibody titer from Day 1 to Day 29
Timeframe: From Day 1 (baseline) to Day 29
Percentage of participants with antigen 2 antibody SCR
Timeframe: From Day 1 to Day 29
Secondary outcomes:
GMT of antigen 1 antibody titer
Timeframe: At Day 92
GMT of antigen 1 antibody titer
Timeframe: At Day 183
GMI of antigen 1 antibody titer from Day 1 to Day 92
Timeframe: From Day 1 (baseline) to Day 92
GMI of antigen 1 antibody titer from Day 1 to Day 183
Timeframe: From Day 1 (baseline) to Day 183
Percentage of participants with antigen 1 antibody SPR
Timeframe: At Day 183
GMT of antigen 2 antibody titer
Timeframe: At Day 92 and Day 183
GMI of antigen 2 antibody titer
Timeframe: From Day 1 to Day 92 and Day 1 to Day 183
Interventions:
Enrollment:
1275
Primary completion date:
2024-02-07
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Influenza, Human
Product
Not applicable
Collaborators
CureVac AG
Study date(s)
April 2023 to December 2024
Type
Interventional
Phase
1/2
Participation criteria
Sex
Female & Male
Age
18 - 85 Years
Accepts healthy volunteers
Yes
- A male or female between and including 18 and 50 years of age in Phase 1 and between and including 18 and 85 years of age (YA: 18-64; OA: 65-85) in Phase 2 at the time of the study intervention administration.
- Healthy participants or medically stable participants as established by medical history, clinical examination, and safety laboratory assessments. Participants with chronic medical conditions with or without specific treatment 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.
- Medical conditions
- Only in Phase 1: Any clinically significant* hematological, biochemical, urinalysis or (hemoglobin A1c) HbA1c laboratory abnormality.
Inclusion and exclusion criteria
Inclusion criteria:
- A male or female between and including 18 and 50 years of age in Phase 1 and between and including 18 and 85 years of age (YA: 18-64; OA: 65-85) in Phase 2 at the time of the study intervention administration.
- Healthy participants or medically stable participants as established by medical history, clinical examination, and safety laboratory assessments. Participants with chronic medical conditions with or without specific treatment 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.
- Body mass index (BMI) >=18 kilograms per meter square (kg/m^2) and less than or equal to (<=) 35 kg/m^2.
- Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- Written informed consent obtained from the participant prior to performing any study-specific procedure.
- Female participants of non-childbearing potential may be enrolled in the study.
- Female participants of childbearing potential may be enrolled in the study if the participant:
- has practiced adequate contraception for 28 days prior to study intervention administration, and
- has a negative pregnancy test on the day of study intervention administration, and
- has agreed to continue adequate contraception for at least 1 month after study intervention administration
Exclusion criteria:
- Medical conditions
- Only in Phase 1: Any clinically significant* hematological, biochemical, urinalysis or (hemoglobin A1c) HbA1c laboratory abnormality. *The investigator should use the clinical judgment to decide which abnormalities are clinically significant.
- Participant tested positive for influenza by local health authority-approved testing methods within 180 days prior to Day 1.
- Current or past malignancy, unless completely resolved without clinically significant sequelae for >5 years.
- 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 participants have been stable on antiretroviral therapy for the past 6 consecutive months, i.e., their treatment has not been modified, their cluster of differentiation 4 (CD4) cell count is >=200/cubic millimeter (mm^3) and their viral load has been undetectable (i.e., HIV-RNA less than (<) 50 copies/milliliter [mL]) (based on medical records, no laboratory testing required).
- History of myocarditis or pericarditis less than or equal to 10 years prior to vaccine administration, including a history of myocarditis or pericarditis following vaccination with an mRNA coronavirus disease 2019 (COVID-19) vaccine.
- Participants with history of hypersensitivity or severe allergic reaction to any previous vaccine or hypersensitivity likely to be exacerbated by any component of the study intervention (including latex, polyethylene glycol, egg protein and aminoglycoside antibiotics).
- History of, or 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.
- Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
- Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study. Prior/Concomitant therapy
- Administration of an influenza vaccine (including any of the study investigational vaccines) within 180 days before enrollment or planned administration within 28 days (Day 29) after the study intervention administration.
- Phase 1: Administration of a vaccine not foreseen by the study protocol in the period starting 28 days (Day -28) before the study intervention administration or planned administration within 28 days (Day 29) after the study intervention administration. Phase 2: Administration of a vaccine not foreseen by the study protocol in the period starting 15 days (Day -15) before the study intervention administration or planned administration within 28 days (Day 29) after the study intervention administration. *In case emergency mass vaccination for an unforeseen public health threat is recommended and/or organized by public health authorities outside the routine immunization program, the time period described above can be reduced to 7 days if, necessary for that vaccine, provided it is used according to the local governmental recommendations and that the Sponsor is notified accordingly.
- Use of any investigational or non-registered product (drug, vaccine, or invasive medical device) other than the study intervention during the period beginning 30 days before the study intervention administration, or their planned use during the study period.
- Administration of long-acting immune-modifying drugs within 90 days before enrollment or planned use at any time during the study period.
- Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the study intervention administration, or planned administration during the study period. Administration of monoclonal antibodies specifically directed against the spike protein of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), for treatment of COVID-19 disease is allowed.
- Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the study intervention administration. For corticosteroids, this will mean prednisone equivalent >=20 milligrams (mg)/day. Inhaled, topical and intraarticular steroids are allowed. Other exclusions
- 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).
- Pregnant or lactating female.
- Bedridden participants.
- Female planning to become pregnant or planning to discontinue contraceptive precautions within the 1-month post-dosing period.
- Alcoholism or substance use disorder within the past 24 months based on the presence of 2 or more of the following abuse criteria: hazardous use, social/interpersonal problems related to use, neglect of major roles to use, withdrawal, tolerance, use of larger amounts or longer, repeated attempts to quit or control use, much time spent using, physical or psychological problems related to use, activities given up to use, craving.
- 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.
Trial location(s)
Location
GSK Investigational Site
East Greenwich, RI, United States, 02818
Status
Study Complete
Location
GSK Investigational Site
Newport News, VA, United States, 23606
Status
Study Complete
Location
GSK Investigational Site
Rockville, MD, United States, 20850
Status
Terminated/Withdrawn
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2024-02-07
Actual study completion date
2024-18-12
Plain language summaries
Summary of results in plain language
Available language(s): English, Afrikaans, Dutch (Belgium), French (Belgium), French (Canadian), Sesotho, Setswana, Spanish (United States), Zulu, Xhosa
To view plain language summaries on trialsummaries.com click here.
Additional information about the trial
Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website