A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline Biologicals' Influenza Vaccine GSK3206641A Administered in Adults 18 to 64 Years of Age and 65 Years of Age and Older

NCT04789577 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 209671
• Study Type: interventional
• Target: 833
• Locations: 1 country
• Sites: 8

Brief Summary

Study to evaluate the safety and immunogenicity of H7N9 antigen in combination with full or half doses of AS03 adjuvant system in healthy adults.

Conditions

Influenza, Human

Outcome Measures

Primary Outcomes (14)

• Percentage of Seroprotected Participants for Anti-hemagglutination Inhibition (HI) Antibodies Against Vaccine-homologous H7N9

  Center for Biologics Evaluation and Research (CBER) criteria for seroprotection rate (SPR) for 18 to 64 years of age is shown if the Lower Limit (LL) of the 99.17% confidence interval (CI) for the SPR meets or exceeds 70%, and for greater than or equal to (≥) 65 years of age if the LL of the 99.17% CI for the SPR meets or exceeds 60%. SPR is defined as the percentage of participants with an HI antibody titer ≥40 1/dilution (DIL). The percentage of participants was calculated along with Clopper-Pearson exact two-sided 99.17% CIs.

  At Day 43

• Percentage of Seroconverted Participants for Anti-HI Antibodies Against Vaccine-homologous H7N9

  CBER criteria for seroconversion rate (SCR) for 18 to 64 years of age is shown if LL of the 99.17% CI for the SCR meets or exceeds 40%, and for ≥65 years of age, if the LL of the 99.17% CI for the SCR meets or exceeds 30%. Seroconversion is defined as a post-vaccination antibody titer ≥40 1/DIL in the serum of participants seronegative before vaccination (i.e. titer \< assay cut-off at Day 1). For seropositive participants (i.e. titer ≥ assay cut-off at Day 1), seroconversion requires a 4-fold rise in post-vaccination HI antibody titer (but at least a titer of 40 1/DIL). The percentage of participants was calculated with Clopper-Pearson exact two-sided 99.17% CIs. Note: The cut-off value for antibody titer was defined by the laboratory before the analysis.

  At Day 43

• Number of Participants With Any Solicited Administration Site Events

  Solicited administered site events assessed were pain, redness and swelling. Any Pain = occurrence of symptom regardless of intensity grade. Any Redness or any Swelling symptom = any symptom having a surface diameter greater than (\>) 20 millimeters (mm).

  Within the 7-day follow-up period after Dose 1

• Number of Participants With Any Solicited Administration Site Events

  Solicited administered site events assessed were pain, redness and swelling. Any Pain = occurrence of symptom regardless of intensity grade. Any Redness or any Swelling symptom = any symptom having a surface diameter \>20 mm.

  Within the 7-day follow-up period after Dose 2

• Number of Participants With Any Solicited Systemic Events

  Solicited systemic events assessed were fatigue, fever, headache, muscle ache all over body, joint pain, shivering, sweating and gastrointestinal symptoms (Nausea, vomiting, diarrhea and abdominal pain). Any = occurrence of symptom regardless of intensity grade. Fever was defined as temperature ≥38 degrees Celsius (°C) for oral route (preferred location for measuring temperature).

  Within the 7-day follow-up period after Dose 1

• Number of Participants With Any Solicited Systemic Events

  Solicited systemic events assessed were fatigue, fever, headache, muscle ache all over body, joint pain, shivering, sweating and gastrointestinal symptoms (Nausea, vomiting, diarrhea and abdominal pain). Any = occurrence of symptom regardless of intensity grade. Fever was defined as temperature ≥38°C for oral route (preferred location for measuring temperature).

  Within the 7-day follow-up period after Dose 2

• Number of Participants With Any and Related Unsolicited Adverse Events

  An unsolicited adverse event (AE) is an AE that was not solicited using a Participant Diary and that was spontaneously communicated by a participant who had signed the informed consent. Unsolicited AEs include serious and non-serious AEs. Potential unsolicited AEs may have been medically attended (i.e. symptoms or illnesses requiring a hospitalization, or emergency room visit, or visit to/by a health care provider). Unsolicited AEs that were not medically attended nor perceived as a concern by participant were collected during interview with the participants and by review of available medical records at the following visit. An unsolicited adverse event is any event reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.

  Within the 21-day follow-up period after Dose 1

• Number of Participants With Any and Related Unsolicited Adverse Events

  An unsolicited AE is an AE that was not solicited using a Participant Diary and that was spontaneously communicated by a participant who has signed the informed consent. Unsolicited AEs include serious and non-serious AEs. Potential unsolicited AEs may have been medically attended (i.e. symptoms or illnesses requiring a hospitalization, or emergency room visit, or visit to/by a health care provider). Unsolicited AEs that were not medically attended nor perceived as a concern by participant are collected during interview with the participants and by review of available medical records at the next visit. An unsolicited adverse event is any event reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.

  Within the 21-day follow-up period after Dose 2

• Number of Participants With Any and Related Medically Attended Adverse Events (MAEs)

  MAEs were defined as adverse events with medically-attended visits that are not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason.

  Within the 21-day follow-up period after Dose 1

• Number of Participants With Any and Related MAEs

  MAEs were defined as adverse events with medically-attended visits that are not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason.

  Within the 21-day follow-up period after Dose 2

• Number of Participants With Any and Related Serious Adverse Events (SAEs)

  A SAE is any untoward medical occurrence that results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization or result in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant. Abnormal pregnancy outcomes were also considered (e.g. spontaneous abortion, fatal death, stillbirth, congenital anomalies, ectopic pregnancy) or other situations where medical or scientific judgement was exercised in deciding whether reporting was appropriate.

  From Day 1 up to Day 43

• Number of Participants With Any and Related Potential Immune Mediated Diseases (pIMDs)

  pIMDs are a subset of adverse events of special interest that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have had an autoimmune etiology.

  From Day 1 up to Day 43

• Number of Participants With Any pIMDs

  pIMDs are a subset of adverse events of special interest that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have had an autoimmune etiology.

  From Day 1 up to Month 13

• Number of Participants With Any SAEs

  A SAE is any untoward medical occurrence that results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization or result in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant. Abnormal pregnancy outcomes were also considered (e.g. spontaneous abortion, fatal death, stillbirth, congenital anomalies, ectopic pregnancy) or other situations where medical or scientific judgement was exercised in deciding whether reporting was appropriate.

  From Day 1 up to Month 13

Secondary Outcomes (8)

• HI Antibody Titers Against Vaccine-homologous H7N9

  At Day 1, Day 22 and Day 43

• Percentage of Seropositive Participants for HI Antibodies Against Vaccine-homologous H7N9

  At Day 1, Day 22 and Day 43

• Percentage of Seroconverted Participants for HI Antibodies Against Vaccine-homologous H7N9

  At Day 22

• Percentage of Seroprotected Participants for HI Antibodies Against Vaccine-homologous H7N9

  At Day 1 and Day 22

• Mean Geometric Increase (MGI) of HI Antibody Titers Against Vaccine-homologous H7N9

  At Day 22 (post-Dose 1/pre-vaccination) and Day 43 (post-Dose 2/pre-vaccination)

Study Arms (7)

FLU-Q-PAN H7N9 Formulation 1_B Group

ACTIVE COMPARATOR

Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.

Biological: FLU-Q-PAN H7N9 Formulation 1; Biological: AS03B

FLU-Q-PAN H7N9 Formulation 1_A Group

ACTIVE COMPARATOR

Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.

Biological: FLU-Q-PAN H7N9 Formulation 1; Biological: AS03A

FLU-Q-PAN H7N9 Formulation 2_B Group

ACTIVE COMPARATOR

Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.

Biological: FLU-Q-PAN H7N9 Formulation 2; Biological: AS03B

FLU-Q-PAN H7N9 Formulation 2_A Group

ACTIVE COMPARATOR

Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.

Biological: FLU-Q-PAN H7N9 Formulation 2; Biological: AS03A

FLU-Q-PAN H7N9 Formulation 3_B Group

ACTIVE COMPARATOR

Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.

Biological: FLU-Q-PAN H7N9 Formulation 3; Biological: AS03B

FLU-Q-PAN H7N9 Formulation 3_A Group

ACTIVE COMPARATOR

Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.

Biological: FLU-Q-PAN H7N9 Formulation 3; Biological: AS03A

Placebo Group

PLACEBO COMPARATOR

Healthy male and female participants who received two doses of placebo, the first dose at Day 1 and the second dose at Day 22.

Drug: Placebo

Interventions

FLU-Q-PAN H7N9 Formulation 1 BIOLOGICAL

Participants received two doses of the FLU-Q-PAN H7N9 Formulation 1 vaccine by intramuscular injection in the non-dominant arm.

FLU-Q-PAN H7N9 Formulation 1_A Group; FLU-Q-PAN H7N9 Formulation 1_B Group

FLU-Q-PAN H7N9 Formulation 2 BIOLOGICAL

Participants received two doses of the FLU-Q-PAN H7N9 Formulation 2 vaccine by intramuscular injection in the non-dominant arm.

FLU-Q-PAN H7N9 Formulation 2_A Group; FLU-Q-PAN H7N9 Formulation 2_B Group

FLU-Q-PAN H7N9 Formulation 3 BIOLOGICAL

Participants received two doses of the FLU-Q-PAN H7N9 Formulation 3 vaccine by intramuscular injection in the non-dominant arm.

FLU-Q-PAN H7N9 Formulation 3_A Group; FLU-Q-PAN H7N9 Formulation 3_B Group

AS03B BIOLOGICAL

Participants received two doses of the AS03B adjuvant by intramuscular injection in the non-dominant arm.

FLU-Q-PAN H7N9 Formulation 1_B Group; FLU-Q-PAN H7N9 Formulation 2_B Group; FLU-Q-PAN H7N9 Formulation 3_B Group

AS03A BIOLOGICAL

Participants received two doses of the AS03A adjuvant by intramuscular injection in the non-dominant arm.

FLU-Q-PAN H7N9 Formulation 1_A Group; FLU-Q-PAN H7N9 Formulation 2_A Group; FLU-Q-PAN H7N9 Formulation 3_A Group

Placebo DRUG

Participants received two doses of Placebo by intramuscular injection in the non-dominant arm.

Placebo Group

Eligibility Criteria

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

You may qualify if:

• Healthy 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 first vaccination.
• Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards and COVID-19 assessment card, return for follow-up visits, or return the diary cards and COVID-19 assessment card in a timely manner using the pre stamped envelope received at the site).
• Written or witnessed/thumb printed informed consent obtained from the participant prior to performance of any study specific procedure.
• Female participants of non-childbearing potential may be enrolled in the study. Non childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion hysterectomy, bilateral ovariectomy or post-menopause.
• Female participants of childbearing potential may be enrolled in the study, if the participant:
• has practiced adequate contraception for 1 month prior to 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.

You may not qualify if:

• Current diagnosis or history of autoimmune disorder(s).
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
• Hypersensitivity to latex.
• Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality that appears uncontrolled, as determined by history or physical examination.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
• Recurrent history or uncontrolled neurological disorders or seizures.
• History of Guillain-Barré syndrome.
• Diagnosed with narcolepsy; or history of narcolepsy in a participant's parent, sibling or child.
• 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 (for example, with tamoxifen) are eligible.
• Documented human immunodeficiency virus-positive participant.
• Any clinically significant\* hematological laboratory abnormality.
• \*The investigator should use his/her clinical judgement to decide which abnormalities are clinically significant.
• Bedridden participants.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (8)

GSK Investigational Site

Stockbridge, Georgia, 30281, United States

Location

GSK Investigational Site

Meridian, Idaho, 83642, United States

Location

GSK Investigational Site

Cary, North Carolina, 27518, United States

Location

GSK Investigational Site

Wilmington, North Carolina, 28401, United States

Location

GSK Investigational Site

Cleveland, Ohio, 44122, United States

Location

GSK Investigational Site

Mt. Pleasant, South Carolina, 29464, United States

Location

GSK Investigational Site

Houston, Texas, 77081, United States

Location

GSK Investigational Site

West Jordan, Utah, 84088, United States

Location

Related Publications (1)

• Hastie A, Clarke T, Germain S, Ollinger T, Lese P, Gupta V. Immunogenicity and Safety of AS03-Adjuvanted H7N9 Influenza Vaccine in Adults (18-64 and >/=65 Years): A Phase 1/2, Randomized, Placebo-Controlled Trial. Influenza Other Respir Viruses. 2024 Dec;18(12):e70020. doi: 10.1111/irv.70020.

  PMID: 39702896 DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

AS03 adjuvant

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

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2021
• First Posted: March 9, 2021
• Study Start: March 16, 2021
• Primary Completion: September 12, 2022
• Study Completion: September 12, 2022
• Last Updated: October 10, 2023
• Results First Posted: October 10, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the 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 can be granted, when justified, for up to another 12 months.

Locations

US (8)