A Study on the Efficacy of a Vaccine Against Influenza in Adults ≥65 Years of Age
ConditionInfluenza, Human
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age65+
SponsorGlaxoSmithKline
About this trial
This study will compare an investigational mRNA flu vaccine with a licensed flu vaccine in adults 65 years of age and older. Participants will receive one injection and will be followed during the flu season. The study will measure prevention of laboratory-confirmed flu illness, side effects, and immune responses.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol independently or with the assistance of a caregiver.
Written or witnessed (physically or digitally) informed consent obtained from the participant/Legally acceptable representative [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 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 or female participant at least 65 YOA at the time of the study intervention administration.
Disqualifiers
History of test-confirmed influenza infection within 180 days prior to study intervention administration.
Any confirmed or suspected immunosuppressive or immunodeficient condition. HIV-infected individuals may be enrolled if they have been stable on antiretroviral therapy for the past 6 consecutive months, their CD4 cell count is ≥ 200/mm³ and their viral load has been undetectable.
Hypersensitivity to latex.
History of myocarditis or pericarditis considered causally associated with mRNA vaccine.
Trial design
Design model
Parallel
Treatments tested in this trial
mRNA Seasonal Flu vaccine
Combination productSingle-dose intramuscular administration of the season-adapted investigational mRNA Seasonal Flu vaccine.
Licensed Influenza Vaccine
Combination productSingle-dose intramuscular administration of an age-appropriate and season-adapted licensed influenza vaccine used as the active comparator.
Treatment groups
54,000 Participants
are divided into 2 treatment groupsGroup A: mRNA Seasonal Flu VaccineExperimental treatment 1 intervention
Group B: Active ComparatorActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Laboratory-confirmed protocol-defined influenza-like illness (ILI) assessed by incidence rate ratio
First occurrence of laboratory-confirmed protocol-defined ILI caused by influenza A subtypes and B lineage. Protocol-defined ILI is defined as the simultaneous occurrence of at least 1 respiratory symptom and at least 1 systemic symptom. Respiratory symptoms include nasal congestion, sore throat, new or increased sputum, new or increased cough, new or increased dyspnea, or wheezing. Systemic symptoms include temperature \>37.2°C/99°F or feverishness, fatigue, myalgia, or headache. The endpoint will be assessed using an incidence rate approach. Relative vaccine efficacy will be calculated as 100 × (1 - incidence rate ratio).
Time frame
From Day 15 through the end of the influenza Season2
Number of Participants with Solicited Administration Site Adverse Events (AEs)
The solicited administration site AEs considered are pain, redness, swelling and lymphadenopathy. Lymphadenopathy is defined as localized axillary, cervical or supraclavicular swelling or tenderness ipsilateral to the injection arm.
Time frame
From Day 1 to Day 73
Number of Participants with Solicited Systemic AEs
The solicited systemic AEs considered are fever, headache, fatigue, myalgia, arthralgia and chills. Fever is defined as temperature greater than or equal to (\>=) 38 °C/100.4 °F regardless the location of measurement.
Time frame
From Day 1 to Day 74
Number of Participants with Unsolicited AEs
An unsolicited AE is an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events.
Time frame
From Day 1 to Day 28Secondary outcomes
1
Laboratory-confirmed protocol-defined ILI assessed for relative vaccine efficacy by incidence rate ratio
First occurrence of laboratory-confirmed protocol-defined ILI caused by influenza A subtypes and B lineage. This endpoint will assess the incidence rate of the investigational mRNA Seasonal Flu vaccine compared with the licensed influenza vaccine comparator.
Time frame
From Day 15 through the end of the influenza Season2
Severe Influenza Disease (SID) assessed by incidence rate ratio
First occurrence of severe influenza disease caused by influenza A or B. Severe influenza disease includes serious influenza-related outcomes such as pneumonia, hospitalization, or death associated with laboratory-confirmed influenza.
Time frame
From Day 15 through the end of the influenza Season3
Laboratory-confirmed Centers for Disease Control and Prevention-defined ILI assessed by incidence rate ratio
First occurrence of laboratory-confirmed Centers for Disease Control and Prevention-defined ILI caused by influenza A subtypes and B lineage.
Time frame
From Day 15 through the end of the influenza Season4
Laboratory-confirmed modified Centers for Disease Control and Prevention-defined ILI assessed by incidence rate ratio
First occurrence of laboratory-confirmed modified Centers for Disease Control and Prevention-defined ILI caused by influenza A subtypes and B lineage.
Time frame
From Day 15 through the end of the influenza SeasonSponsors and contacts
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Source ClinicalTrials.gov