Phase 1
Completed N=468
A Study to Evaluate the Reactogenicity, Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Investigational Supra-seasonal Universal Influenza Vaccines - Inactivated (SUIVs) (GSK3816302A) in Healthy Adults Aged 18 to 39 Years
Influenza, Human
Source: ClinicalTrials.gov NCT03275389 ↗
Enrolled (actual)
468
Serious AEs
3.6%
Results posted
May 2021
Primary outcomePrimary: Number of Subjects With Solicited Local Adverse Events (AEs) After First Dose Administration — 1; 3; 2; 2 Participants
Summary
The purpose of this study is to assess the reactogenicity, safety and immunogenicity of different formulations of GlaxoSmithKline (GSK) Biologicals' investigational supra-seasonal universal influenza vaccines (SUIVs) (unadjuvanted or adjuvanted) in 18 to 39 year-old healthy subjects. Subjects will be enrolled and vaccinated with one or 2 primary dose(s) followed by a booster dose one year later.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Solicited Local Adverse Events (AEs) After First Dose Administration |
1; 3; 2; 2; 1; 3 | — |
| PRIMARY Number of Subjects With Solicited Local AEs After Second Dose Administration |
0; 0; 1; 0; 0; 0 | — |
| PRIMARY Number of Subjects With Solicited Local AEs After Booster Dose Administration |
1; 1; 0; 0; 1; 1 | — |
| PRIMARY Number of Subjects With Solicited General AEs After First Dose Administration |
4; 6; 9; 2; 3; 8 | — |
| PRIMARY Number of Subjects With Solicited General AEs After Second Dose Administration |
3; 4; 4; 0; 4; 4 | — |
| PRIMARY Number of Subjects With Solicited General AEs After Booster Dose Administration |
6; 8; 4; 4; 9; 4 | — |
| PRIMARY Number of Subjects With Any Unsolicited AEs Post-vaccination Period |
27; 23; 23; 24; 24; 17 | — |
| PRIMARY Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Subjects With Any Medically-attended Adverse Events (MAEs) |
21; 16; 20; 23; 21; 14 | — |
| PRIMARY Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Subjects With Serious Adverse Events (SAEs). |
2; 1; 1; 2; 2; 2 | — |
| PRIMARY Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)- Day 1 |
45; 46; 47; 47; 48; 47 | — |
| PRIMARY Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by ELISA- Day 29 |
43; 40; 41; 40; 42; 42 | — |
| PRIMARY Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by ELISA- Day 85 |
39; 36; 34; 35; 39; 35 | — |
| PRIMARY Concentrations of Serum H1 Stalk Antibodies Measured by ELISA- Day 1 |
8887.9; 8719.3; 9691; 9121; 9948.6; 8555.5 | — |
| PRIMARY Concentrations of Serum H1 Stalk Antibodies Measured by ELISA- Day 29 |
112973.2; 45645; 116596.8; 61634.2; 46596.2; 67114.6 | — |
| PRIMARY Concentrations of Serum H1 Stalk Antibodies Measured by ELISA- Day 85 |
45351.6; 28437.5; 74639.7; 30419.3; 25718.6; 48775.9 | — |
| PRIMARY Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by Microneutralization (MN) Assay - Day 1 |
32; 34; 35; 36; 33; 40 | — |
| PRIMARY Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by MN Assay - Day 29 |
43; 40; 40; 40; 41; 41 | — |
| PRIMARY Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by MN Assay - Day 85 |
36; 35; 34; 31; 38; 35 | — |
| PRIMARY Titers for Serum H1 Stalk Antibodies Measured by MN Assay - Day 1 |
40.6; 45.4; 45.9; 45.8; 41.9; 45.1 | — |
| PRIMARY Titers for Serum H1 Stalk Antibodies Measured by MN Assay - Day 29 |
100.3; 109.3; 113.1; 105.6; 96.4; 89.8 | — |
| PRIMARY Titers for Serum H1 Stalk Antibodies Measured by MN Assay - Day 85 |
73; 98.9; 122.7; 59.6; 87.4; 109.8 | — |
| PRIMARY Percentage of Subjects With a ≥ 4-fold Increase of Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 29 |
88.4; 60; 87.8; 70; 52.4; 83.3 | — |
| PRIMARY Percentage of Subjects With a ≥ 4-fold Increase of Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 85 |
51.3; 44.4; 79.4; 37.1; 20.5; 80 | — |
| PRIMARY Percentage of Subjects With a ≥ 4-fold Increase of Anti-H1 Stalk Titer Measured by MN Assay - Day 29 |
40.5; 39.5; 31.6; 41; 36.8; 31.7 | — |
| PRIMARY Percentage of Subjects With a ≥ 4-fold Increase of Anti-H1 Stalk Titer Measured by MN Assay - Day 85 |
29.7; 38.2; 34.4; 15.2; 31.4; 41.2 | — |
| PRIMARY Percentage of Subjects With a ≥ 10-fold Increase of Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 29 |
58.1; 35; 61; 30; 21.4; 42.9 | — |
| PRIMARY Percentage of Subjects With a ≥ 10-fold Increase of Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 85 |
12.8; 5.6; 47.1; 17.1; 5.1; 25.7 | — |
| PRIMARY Percentage of Subjects With a ≥ 10-fold Increase of Anti-H1 Stalk Titer Measured by MN Assay - Day 29 |
7.1; 7.9; 10.5; 5.1; 7.9; 4.9 | — |
| PRIMARY Percentage of Subjects With a ≥ 10-fold Increase of Anti-H1 Stalk Titer Measured by MN Assay - Day 85 |
2.7; 8.8; 15.6; 3; 8.6; 8.8 | — |
| PRIMARY Mean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 29 |
12.4; 5.9; 12.6; 6.8; 4.7; 8.1 | — |
| PRIMARY MGI for Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 85 |
5; 3.4; 8.1; 3.4; 2.6; 6.3 | — |
| PRIMARY MGI for Anti-H1 Stalk Antibody Titer Measured by MN Assay - Day 29 |
2.4; 2.6; 2.4; 2.3; 2.3; 2 | — |
| PRIMARY MGI for Anti-H1 Stalk Antibody Titer Measured by MN Assay - Day 85 |
1.6; 2.2; 2.5; 1.1; 2; 2.5 | — |
| SECONDARY Adjusted GMCs for Anti-H1 HA Stalk Antibody Measured by ELISA |
112206.4; 47432.6; 73945.6; 61356.7; 45346.6; 50602.8 | — |
| SECONDARY Concentrations of Serum H1 Stalk Antibodies Measured by ELISA- Month 8 to 26 |
27068.3; 17155.9; 41759.7; 18915.3; 15092.4; 25279.1 | — |
| SECONDARY Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by ELISA- Month 8 to 26 |
39; 34; 30; 27; 36; 33 | — |
| SECONDARY Percentage of Subjects With a ≥ 4-fold Increase of Anti-H1 Stalk Antibody Concentration, Measured by ELISA - Month 8 to 26. |
23.1; 23.5; 53.3; 14.8; 5.6; 39.4 | — |
| SECONDARY Percentage of Subjects With a ≥ 10-fold Increase of Anti-H1 Stalk Antibody Concentration, Measured by ELISA - Month 8 to 26. |
7.7; 0; 23.3; 7.4; 0; 9.1 | — |
| SECONDARY MGI for Anti-H1 Stalk Antibody Measured by ELISA - Month 8 to 26 |
2.9; 2.3; 4.7; 2; 1.4; 3.3 | — |
| SECONDARY Concentrations of Anti-H2 and Anti-H18 Antibodies Measured by ELISA |
5848.2; 5975.5; 6882.1; 5968.7; 6704; 5513.6 | — |
| SECONDARY Number of Seropositive Subjects for Anti-H2 and Anti-H18 Antibodies Measured by ELISA |
45; 46; 47; 47; 48; 47 | — |
| SECONDARY Percentage of Subjects With a ≥ 4-fold Increase of Anti-H2 and Anti-H18 Antibody Concentration Measured by ELISA |
95.3; 62.5; 92.7; 82.5; 57.1; 90.5 | — |
| SECONDARY Percentage of Subjects With a ≥ 10-fold Increase of Anti-H2 and Anti-H18 Antibody Concentration Measured by ELISA |
67.4; 15; 68.3; 42.5; 16.7; 61.9 | — |
| SECONDARY MGI for Anti-H2 and Anti-H18 Antibodies Concentrations Measured by ELISA |
18.4; 5.3; 17.3; 9.9; 4.7; 12.3 | — |
| SECONDARY Titers for Anti-H1N1 Swine Influenza and Anti-IIV4-H1N1 Anti-bodies Measured by MN Assay |
58.8; 61; 62.9; 51.7; 53.7; 56.2 | — |
| SECONDARY Number of Seropositive Subjects for Anti-H1N1 Swine Influenza and Anti-IIV4-H1N1 Antibodies Measured by MN Assay |
40; 41; 43; 38; 42; 42 | — |
| SECONDARY Percentage of Subjects With a ≥ 4-fold Increase of Anti-H1N1 Swine Influenza and Anti-IIV4-H1N1 Antibody Titers Measured by MN Assay |
9.3; 22.5; 7.7; 23.1; 24.4; 9.5 | — |
| SECONDARY Percentage of Subjects With a ≥ 10-fold Increase of Anti-H1N1 Swine Influenza and Anti-IIV4-H1N1 Antibody Titers Measured by MN Assay |
2.3; 2.5; 0; 0; 0; 0 | — |
| SECONDARY MGI for Anti-H1N1 Swine Influenza and Anti-IIV4-H1N1 Antibodies Titers Measured by MN Assay |
1.4; 1.7; 1.4; 1.7; 1.7; 1.4 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- Written informed consent obtained from the subject prior to performance of any study specific procedure.
- A male or female between, and including, 18 and 39 years of age at the time of the first vaccination.
- Healthy subjects without acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as established by medical history and clinical examination before first vaccination and laboratory screening tests (the latter being only applicable for subjects enrolled in Phase I).
- Subjects with no history of influenza vaccination within 6 months prior to first study vaccination and who are willing to forego any influenza vaccination during the entire study period.
- Female subjects of childbearing potential may be enrolled in the study, if the subject:
- Has practiced adequate contraception for 30 days prior to first vaccination, and
- Has a negative pregnancy test on the day of vaccination, and
- Has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series (last vaccination at Month 14).
Exclusion Criteria
- Use of any investigational or non-registered product other than the study vaccines during the period starting 30 days before the first dose of study vaccines, or planned use during the study period.
- Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
- Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting 6 months prior to the first vaccine dose. For corticosteroids, this will mean prednisone ≥ 20 mg/day, or equivalent. Inhaled and topical steroids are allowed.
- Administration of long-acting immune-modifying drugs within 6 months before first vaccination, or planned administration any time during the study period.
- Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose up to the blood sampling at Day 85 and in the period starting 30 days before booster vaccination at Month 14 up to the blood sample at Month 14 + 28 days.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.
- Previous vaccination against influenza within the 6 months preceding the first vaccination at Visit 1 or planned use of such vaccines during the study period.
- History of vaccination with a (pre)pandemic influenza vaccine other than an H1N1pdm09 vaccine or history of laboratory-confirmed influenza infection other than seasonal or H1N1pdm09 influenza.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of or current autoimmune disease.
- Subjects diagnosed with excessive daytime sleepiness or narcolepsy; or history of narcolepsy in a subject's parent or sibling.
- History of Guillain-Barré syndrome.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
- Hypersensitivity to latex.
- Acute disease and/or fever at the time of enrolment.
- Fever is defined as temperature ≥ 38.0°C / 100.4°F. The preferred location for measuring temperature in this study will be the oral cavity.
- Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
- For subjects with acute disease and/or fever at the time of enrolment, Visit 1 may be re-scheduled within the allowed time-window.
- Administration of immunoglobulins and/or any blood products during the period sta
Data sourced from ClinicalTrials.gov (NCT03275389). 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.