Safety and Immunogenicity of Different Formulations of Monovalent Influenza A/Astrakhan/3212/2020 Like (H5N8) Virus Vaccine With AS03 Adjuvant System in Medically Stable Adults

NCT05975840 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 219833
• Study Type: interventional
• Target: 518
• Locations: 1 country
• Sites: 20

Brief Summary

The purpose of this study is to assess the safety and immunogenicity of different formulations of monovalent Influenza A/Astrakhan/3212/2020-like virus vaccine with AS03 adjuvant system in adults greater than or equal to (\>=)18 years of age.

Conditions

Influenza, Human

Keywords

Influenza; Safety; Immunogenicity

Outcome Measures

Primary Outcomes (20)

• Hemagglutination-inhibiting (HI) Antibody Titers Against Vaccine-homologous H5N8

  Antibody titers were presented as geometric mean titers (GMTs).

  At Day 43

• Geometric Mean Fold Rise (GMFR) of Serum HI Antibody Titers Against Vaccine-homologous H5N8

  The GMFR is defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.

  At Day 43

• Number of Seroprotected (SP) Participants for HI Antibody Titers

  Seroprotection rate is defined as the number of participants with HI titer value greater than or equal to (\>=) 1:40 which is considered as indicating protection.

  At Day 43

• Number of Participants Reporting Each Solicited Administration Site Event Following Dose 1

  Solicited administration site events included pain, redness and swelling.

  7 days (Day 1 to Day 7) following dose 1

• Number of Participants Reporting Each Solicited Administration Site Event Following Dose 2

  Solicited administration site events included pain, redness and swelling.

  7 days (Day 22 to Day 28) following dose 2

• Number of Participants Reporting Each Solicited Systemic Event Following Dose 1

  Solicited systemic events included fatigue, fever, headache, muscle ache, joint pain, shivering (chills), sweating, gastrointestinal symptoms (nausea, vomiting, diarrhea, abdominal pain). Fever is defined as temperature \>=38 degrees Celsius (°C) for oral route (preferred location for measuring temperature).

  7 days (Day 1 to Day 7) following dose 1

• Number of Participants Reporting Each Solicited Systemic Event Following Dose 2

  Solicited systemic events included fatigue, fever, headache, muscle ache, joint pain, shivering (chills), sweating, gastrointestinal symptoms (nausea, vomiting, diarrhea, abdominal pain). Fever is defined as temperature \>=38 degrees Celsius (°C) for oral route (preferred location for measuring temperature).

  7 days (Day 22 to Day 28) following dose 2

• Number of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1

  Hemoglobin, white blood cells (WBC) increase, WBC decrease, platelets, neutrophils, lymphocytes and eosinophils were graded by FDA toxicity grading scale in which grades are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = potentially life threatening. Blood samples were collected for safety laboratory tests from the first 50% of participants of each age and dose group, at 7 days following each vaccination (i.e., Visit 2 and Visit 4).

  7 days (Day 1 to Day 7) following dose 1

• Number of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2

  Hemoglobin, WBC increase, WBC decrease, platelets, neutrophils, lymphocytes and eosinophils were graded by FDA toxicity grading scale in which grades are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = potentially life threatening. Blood samples were collected for safety laboratory tests from the first 50% of participants of each age and dose group, at 7 days following each vaccination (i.e., Visit 2 and Visit 4).

  7 days (Day 22 to Day 28) following dose 2

• Number of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1

  Sodium increase, sodium decrease, potassium increase, potassium decrease, creatinine, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, total bilirubin and blood urea nitrogen (BUN) were graded by FDA toxicity grading scale in which grades are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = potentially life threatening. Blood samples were collected for safety laboratory tests from the first 50% of participants of each age and dose group, at 7 days following each vaccination (i.e., Visit 2 and Visit 4).

  7 days (Day 1 to Day 7) following dose 1

• Number of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2

  Sodium increase, sodium decrease, potassium increase, potassium decrease, creatinine, ALT, AST, alkaline phosphatase, total bilirubin and BUN were graded by FDA toxicity grading scale in which grades are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = potentially life threatening. Blood samples were collected for safety laboratory tests from the first 50% of participants of each age and dose group, at 7 days following each vaccination (i.e., Visit 2 and Visit 4).

  7 days (Day 22 to Day 28) following dose 2

• Number of Participants Reporting Unsolicited AEs Following Dose 1

  An unsolicited adverse event is defined as an adverse event 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.

  21 days (Day 1 to Day 22) following dose 1

• Number of Participants Reporting Unsolicited AEs Following Dose 2

  An unsolicited adverse event is defined as an adverse event 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.

  21 days (Day 22 to Day 43) following dose 2

• Number of Participants Reporting Unsolicited Medically Attended Adverse Events (MAEs) Following Dose 1

  MAE is defined as an AE that results in an unscheduled visit to a medical professional (e.g., symptoms or illnesses requiring a hospitalization, emergency room visit, or visit to/by a healthcare provider).

  21 days (Day 1 to Day 22) following dose 1

• Number of Participants Reporting Unsolicited MAEs Following Dose 2

  21 days (Day 22 to Day 43) following dose 2

• Number of Participants Reporting Unsolicited MAEs up to 6 Months Post Dose 2 (Administered on Day 22)

  Up to 6 months post dose 2 (administered on Day 22)

• Number of Participants Reporting Serious Adverse Events (SAEs) up to Day 43

  An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an abnormal pregnancy outcome (e.g., spontaneous abortion, fetal death, stillbirth, congenital anomalies, ectopic pregnancy), or is a suspected transmission of any infectious agent via an authorized medicinal product.

  From Day 1 to Day 43

• Number of Participants Reporting SAEs up to 6 Months Post Dose 2 (Administered on Day 22)

  Day 1 to 6 months post dose 2 (administered on Day 22)

• Number of Participants Reporting Potential Immune-mediated Diseases (pIMDs) up to Day 43

  pIMDs are defined a subset of AEs of special interest that includes autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.

  From Day 1 to Day 43

• Number of Participants Reporting pIMDs up to 6 Months Post Dose 2 (Administered on Day 22)

  Day 1 to 6 months post dose 2 (administered on Day 22)

Secondary Outcomes (7)

• HI Antibody Titers Against Vaccine-homologous H5N8

  Day 1, Day 22, and 6 months post dose 2 (administered on Day 22)

• GMFR of Serum HI Antibody Titers Against Vaccine-homologous H5N8

  At Day 22, and 6 months post dose 2 (administered on Day 22)

• Number of Seroprotected Participants for HI Antibody Titers

  At Day 1, Day 22, and 6 months post dose 2 (administered on Day 22)

• Number of Seroconverted Participants for HI Antibody Titers

  At Day 22, Day 43 and 6 months post dose 2 (administered on Day 22)

• Microneutralization (MN) Antibody Titers for a Subset of Participants

  At Day 1, Day 22, and 6 months post dose 2 (administered on Day 22)

Study Arms (8)

Age group 18-64: FLU Q-PAN H5N8 375_B

ACTIVE COMPARATOR

Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.

Biological: FLU Q-PAN H5N8 375_B

Age group 18-64: FLU Q-PAN H5N8 375_A

ACTIVE COMPARATOR

Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.

Biological: FLU Q-PAN H5N8 375_A

Age group 18-64: FLU Q-PAN H5N8 750_B

ACTIVE COMPARATOR

Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.

Biological: FLU Q-PAN H5N8 750_B

Age group 18-64: FLU Q-PAN H5N8 750_A

ACTIVE COMPARATOR

Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.

Biological: FLU Q-PAN H5N8 750_A

Age group >=65: FLU Q-PAN H5N8 375_B

ACTIVE COMPARATOR

Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.

Biological: FLU Q-PAN H5N8 375_B

Age group >=65: FLU Q-PAN H5N8 375_A

ACTIVE COMPARATOR

Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.

Biological: FLU Q-PAN H5N8 375_A

Age group >=65: FLU Q-PAN H5N8 750_B

ACTIVE COMPARATOR

Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.

Biological: FLU Q-PAN H5N8 750_B

Age group >=65: FLU Q-PAN H5N8 750_A

ACTIVE COMPARATOR

Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.

Biological: FLU Q-PAN H5N8 750_A

Interventions

FLU Q-PAN H5N8 375_B BIOLOGICAL

Participants received 2 doses of 375\_B vaccine formulation by intramuscular injection in the non-dominant arm.

Age group 18-64: FLU Q-PAN H5N8 375_B; Age group >=65: FLU Q-PAN H5N8 375_B

FLU Q-PAN H5N8 375_A BIOLOGICAL

Participants received 2 doses of 375\_A vaccine formulation by intramuscular injection in the non-dominant arm.

Age group 18-64: FLU Q-PAN H5N8 375_A; Age group >=65: FLU Q-PAN H5N8 375_A

FLU Q-PAN H5N8 750_B BIOLOGICAL

Participants received 2 doses of 750\_B vaccine formulation by intramuscular injection in the non-dominant arm.

Age group 18-64: FLU Q-PAN H5N8 750_B; Age group >=65: FLU Q-PAN H5N8 750_B

FLU Q-PAN H5N8 750_A BIOLOGICAL

Participants received 2 doses of 750\_A vaccine formulation by intramuscular injection in the non-dominant arm.

Age group 18-64: FLU Q-PAN H5N8 750_A; Age group >=65: FLU Q-PAN H5N8 750_A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Medically stable participants as established by medical history and clinical examination before entering into the study.
• A male or female \>=18 years of age at the time of signing consent form.
• Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
• Written or witnessed/thumb printed informed consent obtained from the participant prior to performance of any study specific procedure.
• Female participants of childbearing potential or non-childbearing potential may be enrolled in the study if specific criteria are met.

You may not qualify if:

• Current diagnosis or history of autoimmune disorder(s) except hypothyroidism due to Hashimoto's thyroiditis.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
• Clinically significant acute or chronic pulmonary, cardiovascular, hepatic, or renal disease that appears uncontrolled or untreated, as determined by history or physical examination.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history, physical examination, or abnormalities in screening blood tests.
• Recurrent history of or uncontrolled neurological disorders or seizures.
• History of Guillain-Barré syndrome.
• Diagnosed with cancer, or treatment for cancer within 3 years.
• Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible.
• Women who are disease-free 3 years or more after treatment for breast cancer and receiving long-term prophylaxis are eligible.
• Documented human immunodeficiency virus-positive participants.
• Bedridden participants.
• Personal or family history of narcolepsy.
• Food and Drug Administration (FDA) toxicity Grade 2, or greater, laboratory tests at Screening.
• Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
• Use of any investigational or non-registered product other than the study vaccine during the period beginning 30 days before the first dose of study vaccine (Day -29 to Day 1), or planned use during the entire study period.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (20)

GSK Investigational Site

Anniston, Alabama, 36207, United States

Location

GSK Investigational Site

Mobile, Alabama, 36608, United States

Location

GSK Investigational Site

Tempe, Arizona, 85281, United States

Location

GSK Investigational Site

Chula Vista, California, 91911, United States

Location

GSK Investigational Site

Long Beach, California, 90806, United States

Location

GSK Investigational Site

Santa Ana, California, 92705, United States

Location

GSK Investigational Site

Pembroke Pines, Florida, 33025, United States

Location

GSK Investigational Site

Chamblee, Georgia, 30341, United States

Location

GSK Investigational Site

Meridian, Idaho, 83642, United States

Location

GSK Investigational Site

El Dorado, Kansas, 67042, United States

Location

GSK Investigational Site

Lenexa, Kansas, 66219, United States

Location

GSK Investigational Site

Lexington, Kentucky, 40509, United States

Location

GSK Investigational Site

Metairie, Louisiana, 70006, United States

Location

GSK Investigational Site

Anderson, South Carolina, 29621, United States

Location

GSK Investigational Site

Knoxville, Tennessee, 37920, United States

Location

GSK Investigational Site

Austin, Texas, 78745, United States

Location

GSK Investigational Site

Boerne, Texas, 78006, United States

Location

GSK Investigational Site

San Antonio, Texas, 78244, United States

Location

GSK Investigational Site

Tomball, Texas, 77375, United States

Location

GSK Investigational Site

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study will be observer blind.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2023
• First Posted: August 4, 2023
• Study Start: August 3, 2023
• Primary Completion: May 21, 2024
• Study Completion: September 19, 2024
• Last Updated: August 19, 2025
• Results First Posted: February 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

Locations

US (20)