Phase 2
Completed N=833
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
| Outcome | Result | p-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.
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.