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Phase 2 Completed N=1,256 Randomized Quadruple-blind Prevention

A Study to Assess the Safety and Immune Response of a Vaccine Against Influenza in Healthy Younger and Older Adults

Influenza, Human
Source: ClinicalTrials.gov NCT05823974 ↗
Enrolled (actual)
1,256
Serious AEs
1.5%
Results posted
Jul 2025
Primary outcomePrimary: Number of Participants Reporting Any Solicited Administration Site Adverse Events (AEs) — 0; 2; 2; 2 Participants

Summary

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).

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants Reporting Any Solicited Administration Site Adverse Events (AEs)
0; 2; 2; 2; 3; 4
PRIMARY
Number of Participants Reporting Any Solicited Systemic AEs
3; 12; 8; 10; 11; 10
PRIMARY
Number of Participants Reporting Any Unsolicited AEs
7; 10; 5; 7; 6; 12
PRIMARY
Number of Participants Reporting Serious Adverse Events (SAEs)
0; 0; 0; 0; 0; 1
PRIMARY
Number of Participants Reporting AEs of Special Interest (AESIs)
1; 0; 0; 0; 0; 0
PRIMARY
Number of Participants Reporting Medically Attended Events (MAEs)
3; 3; 4; 3; 2; 7
PRIMARY
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
0; 0; 0; 0; 0; 1
PRIMARY
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
0; 0; 0; 0; 0; 0
PRIMARY
Geometric Mean Titer (GMT) of Antigen 1 Antibody Titer
469.49; 335.19; 247.82; 359.26; 380.39; 331.81
PRIMARY
Geometric Mean Increase (GMI) of Antigen 1 Antibody Titers From Day 1 to Day 29
12.83; 9.16; 6.77; 9.81; 10.39; 9.06
PRIMARY
Percentage of Participants With Antigen 1 Antibody Seroconversion Rate (SCR)
78.9; 68.2; 59.1; 65.2; 57.1; 70.8
PRIMARY
Percentage of Participants With Antigen 1 Antibody Seroprotection Rate (SPR)
60.0; 63.6; 50.0; 65.2; 61.9; 37.5
PRIMARY
Percentage of Participants With Antigen 1 Antibody SPR
94.1; 93.3; 86.7; 95.0; 100; 81.3
PRIMARY
GMT of Antigen 2 Antibody Titer
3413.56; 3012.57; 2965.07; 3738.95; 3441.57; 4274.50
PRIMARY
GMI of Antigen 2 Antibody Titer From Day 1 to Day 29
6.99; 5.12; 5.18; 7.30; 6.65; 7.98
PRIMARY
Percentage of Participants With Antigen 2 Antibody SCR
73.9; 63.6; 63.2; 76.2; 86.4; 78.9
SECONDARY
GMT of Antigen 1 Antibody Titer
124.39; 118.75; 100.46; 98.64; 134.12; 96.19
SECONDARY
GMT of Antigen 1 Antibody Titer
124.39; 118.75; 100.46; 98.64; 134.12; 96.19
SECONDARY
GMI of Antigen 1 Antibody Titer From Day 1 to Day 92
6.95; 5.38; 3.96; 4.75; 5.05; 4.52
SECONDARY
GMI of Antigen 1 Antibody Titer From Day 1 to Day 183
3.55; 3.39; 2.87; 2.82; 3.83; 2.75
SECONDARY
Percentage of Participants With Antigen 1 Antibody SPR
94.1; 93.3; 86.7; 95.0; 100; 81.3
SECONDARY
GMT of Antigen 2 Antibody Titer
3413.56; 3012.57; 2965.07; 3738.95; 3441.57; 4274.50
SECONDARY
GMI of Antigen 2 Antibody Titer
4.24; 3.74; 3.68; 4.64; 4.27; 5.31

Eligibility 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 ( 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 ( =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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05823974). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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