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Phase 2 Completed N=833 Randomized Quadruple-blind Prevention

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

Influenza, Human
Source: ClinicalTrials.gov NCT06431607 ↗
Enrolled (actual)
833
Serious AEs
1.8%
Results posted
Mar 2026
Primary outcomePrimary: Part 1 YA: Geometric Mean Titer (GMT) of Antigen 1 Antibody Titer — 12.40; 54.78; 83.98; 98.65 Titers

Summary

The purpose of this study is to assess the safety and immune response of GlaxoSmithKlines (GSK) messenger RNA (mRNA)-based multivalent vaccine (GSK4382276A) candidate against influenza, administered in healthy younger adults (YA) and older adults (OA).

Outcome Measures

OutcomeResultp-value
PRIMARY
Part 1 YA: Geometric Mean Titer (GMT) of Antigen 1 Antibody Titer
12.40; 54.78; 83.98; 98.65; 70.86; 14.79
PRIMARY
Part 2 YA: GMT of Antigen 1 Antibody Titer
132.71; 108.18; 172.12; 105.82; 578.89; 755.99
PRIMARY
Part 1 OA: GMT of Antigen 1 Antibody Titer
56.14; 49.53; 61.63; 71.94; 47.87; 79.97
PRIMARY
Part 2 OA: GMT of Antigen 1 Antibody Titer
104.98; 156.42; 231.42; 230.39; 666.48; 1028.40
PRIMARY
Part 1 YA: Geometric Mean Increase (GMI) of Antigen 1 Antibody Titers
0.91; 6.16; 7.26; 7.56; 4.28; 1.02
PRIMARY
Part 2 YA: GMI of Antigen 1 Antibody Titers
11.58; 8.59; 6.59; 4.89; 2.79; 3.29
PRIMARY
Part 1 OA: GMI of Antigen 1 Antibody Titers
2.96; 4.74; 3.11; 3.47; 2.14; 5.17
PRIMARY
Part 2 OA: GMI of Antigen 1 Antibody Titers
8.01; 8.30; 8.26; 6.61; 2.21; 3.33
PRIMARY
Part 1 YA: Percentage of Participants With Antigen 1 Antibody Seroconversion Rate (SCR)
0; 52.3; 69.8; 64.6; 45.7; 0
PRIMARY
Part 2 YA: Percentage of Participants With Antigen 1 Antibody SCR
76.3; 62.8; 66.7; 44.9; 42.1; 47.4
PRIMARY
Part 1 OA: Percentage of Participants With Antigen 1 Antibody SCR
40.0; 53.2; 31.4; 39.1; 18.4; 56.5
PRIMARY
Part 2 OA: Percentage of Participants With Antigen 1 Antibody SCR
63.3; 63.6; 74.7; 61.8; 24.3; 41.9
PRIMARY
Part 1 YA: Percentage of Participants With Antigen 1 Antibody Seroprotection Rate (SPR)
23.9; 13.6; 20.9; 25.0; 30.4; 23.9
PRIMARY
Part 2 YA: Percentage of Participants With Antigen 1 Antibody SPR
82.9; 87.2; 94.7; 85.9; 100; 100
PRIMARY
Part 1 OA: Percentage of Participants With Antigen 1 Antibody SPR
60.9; 66.0; 61.5; 69.6; 58.0; 76.1
PRIMARY
Part 2 OA: Percentage of Participants With Antigen 1 Antibody SPR
78.5; 90.9; 97.5; 94.8; 100; 100
PRIMARY
Part 1 YA: Percentage of Participants With Antigen 1 Antibody SPR
20.0; 65.9; 76.7; 81.3; 73.9; 26.1
PRIMARY
Part 2 YA: Percentage of Participants With Antigen 1 Antibody SPR
82.9; 87.2; 94.7; 85.9; 100; 100
PRIMARY
Part 1 OA: Percentage of Participants With Antigen 1 Antibody SPR
60.9; 66.0; 61.5; 69.6; 58.0; 76.1
PRIMARY
Part 2 OA: Percentage of Participants With Antigen 1 Antibody SPR
78.5; 90.9; 97.5; 94.8; 100; 100
SECONDARY
Part 1 YA: GMT of Antigen 2 Antibody Titer
156.45; 1296.33; 2400.60; 3058.88; 187.25; 264.10
SECONDARY
Part 2 YA: GMT of Antigen 2 Antibody Titer
950.09; 131.47; 202.44; 83.26; 799.38; 413.77
SECONDARY
Part 1 OA: GMT of Antigen 2 Antibody Titer
1359.58; 1464.19; 1860.40; 1600.51; 179.53; 974.84
SECONDARY
Part 2 OA: GMT of Antigen 2 Antibody Titer
739.45; 116.25; 241.50; 70.51; 733.35; 589.57
SECONDARY
Part 1 YA: GMI of Antigen 2 Antibody Titer
1.25; 12.45; 15.29; 15.30; 1.44; 1.24
SECONDARY
Part 2 YA: GMI of Antigen 2 Antibody Titer
7.55; 0.88; 7.29; 2.47; 5.40; 2.96
SECONDARY
Part 1 OA: GMI of Antigen 2 Antibody Titer
7.42; 9.34; 11.63; 9.62; 1.42; 3.60
SECONDARY
Part 2 OA: GMI of Antigen 2 Antibody Titer
5.06; 1.04; 8.05; 1.87; 4.00; 2.71
SECONDARY
Part 1 YA: Percentage of Participants With Antigen 2 Antibody SCR
0; 85.0; 95.0; 95.2; 4.5; 0
SECONDARY
Part 2 YA: Percentage of Participants With Antigen 2 Antibody SCR
70.3; 2.6; 64.9; 7.7; 59.5; 28.2
SECONDARY
Part 1 OA: Percentage of Participants With Antigen 2 Antibody SCR
60.0; 78.3; 79.2; 95.0; 0; 50.0
SECONDARY
Part 2 OA: Percentage of Participants With Antigen 2 Antibody SCR
56.4; 0; 71.8; 7.5; 48.7; 22.5
SECONDARY
Part 1 YA: Number of Participants Reporting Any Solicited Administration Site Adverse Events (AEs)
25; 31; 30; 33; 21; 2
SECONDARY
Part 2 YA: Number of Participants Reporting Any Solicited Administration Site AEs
46; 23; 3; 0; 3; 1
SECONDARY
Part 1 OA: Number of Participants Reporting Any Solicited Administration Site AEs
27; 31; 36; 35; 21; 6
SECONDARY
Part 2 OA: Number of Participants Reporting Any Solicited Administration Site AEs
42; 21; 3; 1; 5; 2
SECONDARY
Part 1 YA: Number of Participants Reporting Any Solicited Systemic AEs
6; 13; 12; 11; 4; 5
SECONDARY
Part 2 YA: Number of Participants Reporting Any Solicited Systemic AEs
26; 6; 30; 6; 33; 21
SECONDARY
Part 1 OA: Number of Participants Reporting Any Solicited Systemic AEs
12; 12; 16; 13; 9; 11
SECONDARY
Part 2 OA: Number of Participants Reporting Any Solicited Systemic AEs
17; 5; 21; 5; 28; 11
SECONDARY
Part 1 YA: Number of Participants Reporting Any Unsolicited AEs
4; 6; 6; 9; 5
SECONDARY
Part 2 YA: Number of Participants Reporting Any Unsolicited AEs
13; 13
SECONDARY
Part 1 OA: Number of Participants Reporting Any Unsolicited AEs
7; 4; 5; 6; 10
SECONDARY
Part 2 OA: Number of Participants Reporting Any Unsolicited AEs
9; 6
SECONDARY
Part 1 YA: Number of Participants Reporting Serious Adverse Events (SAEs)
0; 1; 1; 2; 2
SECONDARY
Part 2 YA: Number of Participants Reporting SAEs
0; 0
SECONDARY
Part 1 OA: Number of Participants Reporting SAEs
3; 2; 3; 1; 0
SECONDARY
Part 2 OA: Number of Participants Reporting SAEs
0; 0
SECONDARY
Part 1 YA: Number of Participants Reporting AEs of Special Interest (AESIs)
0; 0; 0; 0; 0
SECONDARY
Part 2 YA: Number of Participants Reporting AESIs
0; 0
SECONDARY
Part 1 OA: Number of Participants Reporting AESIs
0; 0; 0; 0; 0
SECONDARY
Part 2 OA: Number of Participants Reporting AESIs
0; 0
SECONDARY
Part 1 YA: Number of Participants Reporting Medically Attended Adverse Events (MAAEs)
4; 4; 4; 7; 4
SECONDARY
Part 2 YA: Number of Participants Reporting MAAEs
4; 2
SECONDARY
Part 1 OA: Number of Participants Reporting MAAEs
8; 5; 6; 5; 8
SECONDARY
Part 2 OA: Number of Participants Reporting MAAEs
7; 4

Eligibility Criteria

Inclusion Criteria

  • A male or female between and including 18 and 85 years of age (YAs: 18-64; OAs: 65-85) at the time of the study intervention administration.
  • 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, 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 significant change in therapy or hospitalization for worsening disease during 3 months before enrolment.
  • Body mass index (BMI) >=18 Kilograms per meter square (kg/m²) and less than or equal to ( ) 5 years before the study intervention administration (excluding effectively treated basal cell skin cancer).
  • 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 cluster of differentiation 4 (CD4) cell count is >= 200/ cubic millimeter (mm³) and their viral load has been undetectable (i.e., HIV-RNA lesser than ( =20 mg/day. Inhaled, intraarticular and topical steroids are allowed.
  • 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.
  • 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 participant.
  • Bedridden participants.
  • Female participant planning to become pregnant or planning to discontinue contraceptive precautions within the 1-month post-dosing period.
  • History of chronic alcohol consumption and/or drug abuse in the past 5 years 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06431607). 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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