A study to find and confirm the dose and assess the safety, reactogenicity and immune response of a vaccine against influenza in healthy younger and older adults

Overview

Sponsor-declared trial summary

Key facts

Sponsor

GlaxoSmithKline Biologicals, GlaxoSmithKline Biologicals

Participant type

Healthy volunteers

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Virus Diseases [C02]

Trial duration

27 Apr 2023 → 18 Dec 2024

Decision date (initial)

2023-04-19

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2022-502308-66-00

ClinicalTrials.gov

NCT05823974

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Safety, Prophylaxis

- To evaluate the safety and reactogenicity profile of the investigational study intervention
- To evaluate the humoral immune response induced by the investigational study intervention

Secondary objectives 1

1. To evaluate the humoral immune response induced by the investigational study intervention

Conditions and MedDRA coding

Healthy volunteers (prevention of influenza infection)

Study design 2 periods

Regulatory references

Scientific advice from competent authorities

Health Canada, Food And Drug Administration, Federal Agency For Medicines And Health Products

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. A male or female between and including 18 and 50 years of age in Phase 1 and between and including 18 and 85 years of age (YA: 18-64; OA: 65-85) in Phase 2 at the time of the study intervention administration.
2. Healthy participants or medically stable patients as established by medical history, clinical examination and safety laboratory assessments. 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 enrollment.
3. Body mass index (BMI) ≥ 18 kg/m² and ≤ 35kg/m²
4. Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiary, return for follow up visits).
5. Written informed consent obtained from the participant prior to performing any study-specific procedure.
6. Female participants of non-childbearing potential may be enrolled in the study.
7. Female participants of childbearing potential may be enrolled in the study if the participant: 1) has practiced adequate contraception for 28 days prior to study intervention administration, and 2) has a negative pregnancy test on the day of study intervention administration, and 3) has agreed to continue adequate contraception for at least 1 month after study intervention administration.

Exclusion criteria 23

1. Only in Phase 1: Any clinically significant* hematological, biochemical, urinalysis or HbA1c laboratory abnormality. *The investigator should use his/her clinical judgment to decide which abnormalities are clinically significant.
2. Participant tested positive for influenza by local health authority-approved testing methods within 180 days prior to Day 1.
3. Current or past malignancy, unless completely resolved without clinically significant sequelae (e.g., scars following surgical resection for treatment of basal cell carcinoma cases are allowed) for >5 years.
4. Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection, based on medical history and physical examination (no laboratory testing required). However, in Phase 2, 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 CD4 cell count is ≥200/mm³ and their viral load has been undetectable (i.e., HIV-RNA <50 copies/mL) (based on medical records, no laboratory testing required). For country specific instruction please refer to Section 10.6.
5. History of myocarditis or pericarditis less than or equal to 10 years prior to vaccine administration, including a history of myocarditis or pericarditis following vaccination with an mRNA COVID-19 vaccine.
6. Participants with history of hypersensitivity or severe allergic reaction to any previous vaccine or hypersensitivity likely to be exacerbated by any component of the study intervention (including latex, polyethylene glycol, egg protein and aminoglycoside antibiotics).
7. History of, or uncontrolled neurological disorders or seizures, including Guillain-Barré syndrome and Bell’s palsy, with the exception of febrile seizures during childhood.
8. Any history of dementia or any medical condition that moderately or severely impairs cognition..
9. Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
10. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study. Prior/Concomitant therapy
11. Administration of an influenza vaccine (including any of the study investigational vaccines) within 180 days before enrollment or planned administration within 28 days (Day 29) after the study intervention administration.
12. Phase 1: Administration of a vaccine not foreseen by the study protocol in the period starting 28 days (Day -28) before the study intervention administration, or planned administration within 28 days (Day 29) after the study intervention administration*. Phase 2: Administration of a vaccine not foreseen by the study protocol in the period starting 15 days (Day -15) before the study intervention administration, or planned administration within 28 days (Day 29) after the study intervention administration*. *In case emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is recommended and/or organized by public health authorities outside the routine immunization program, the time period described above can be reduced to 7 days if, necessary for that vaccine, provided it is used according to the local governmental recommendations and that the Sponsor is notified accordingly.
13. Use of any investigational or non-registered product (drug, vaccine or invasive medical device) other than the study intervention during the period beginning 30 days before the study intervention administration, or their planned use during the study period.
14. Administration of long-acting immune-modifying drugs within 90 days before enrollment or planned use at any time during the study period (e.g., infliximab).
15. Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the study intervention administration, or planned administration during the study period. Administration of monoclonal antibodies specifically directed against the spike protein of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), for treatment of COVID-19 disease is allowed.
16. Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the study intervention administration. For corticosteroids, this will mean prednisone equivalent ≥ 20 mg/day. Inhaled, topical and intraarticular steroids are allowed.
17. 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).
18. Pregnant or lactating female.
19. Bedridden participants.
20. Female planning to become pregnant or planning to discontinue contraceptive precautions within the 1-month post-dosing period.
21. Alcoholism or substance use disorder within the past 24 months based on the presence of 2 or more of the following abuse criteria: hazardous use, social/interpersonal problems related to use, neglect of major roles to use, withdrawal, tolerance, use of larger amounts or longer, repeated attempts to quit or control use, much time spent using, physical or psychological problems related to use, activities given up to use, craving.
22. Any study personnel or their immediate dependents, family, or household members.
23. Participants with extensive tattoos covering deltoid region on both arms that would preclude the assessment of local reactogenicity.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 14

1. Percentage of participants reporting each solicited administration site event (From Day 1 to Day 7)
2. Percentage of participants reporting each solicited systemic event (From Day 1 to Day 7)
3. Percentage of participants reporting unsolicited adverse events (AEs) (From Day 1 to Day 28)
4. Percentage of participants reporting serious adverse events (SAEs) (From Day 1 to Day 183)
5. Percentage of participants reporting adverse events of special interest (AESIs) (From Day 1 to Day 183)
6. Percentage of participants reporting medically attended events (MAEs) (From Day 1 to Day 183)
7. Percentage of participants reporting a shift from a non-clinically significant laboratory value on Day 1 (pre-dose) to a clinically significant abnormal laboratory value on Day 8 (post-dose) and/or Day 29 (post-dose) for hematology and clinical chemistry (Phase 1 only)
8. Geometric mean titer (GMT) of antigen 1 antibody titer (Day 29)
9. Geometric mean increase (GMI) of antigen 1 antibody titer (From Day 1 to Day 29)
10. Percentage of participants with antigen 1 seroconversion rate (SCR) (From Day 1 to Day 29)
11. Percentage of participants with antigen 1 titer >= cut off value (Day 1 and Day 29)
12. GMT of antigen 2 antibody titer (Day 29)
13. GMI of antigen 2 antibody titer (From Day 1 to Day 29)
14. Percentage of participants with antigen 2 SCR (From day 1 to Day 29)

Secondary endpoints 7

1. GMT of antigen 1 antibody titer (Day 92 and Day 183)
2. GMI of antigen 1 antibody titer (From Day 1 to Day 92)
3. GMI of antigen 1 antibody titer (From Day 1 to Day 183)
4. Percentage of participants with antigen 1 titer >= cut off value (Day 183)
5. GMT of antigen 2 antibody titer (Day 92 and Day 183)
6. GMI of antigen 2 antibody titer (From Day 1 to Day 92)
7. GMI of antigen 2 antibody titer (From Day 1 to Day 183)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 16

Comparator 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

GlaxoSmithKline Biologicals

Sponsor organisation

GlaxoSmithKline Biologicals

Address

Rue De L'institut 89

City

Rixensart

Postcode

1330

Country

Belgium

Scientific contact point

Organisation

GlaxoSmithKline Biologicals

Contact name

EU GSK Clinical Trial

Public contact point

Organisation

GlaxoSmithKline Biologicals

Contact name

EU GSK Clinical Trial

Third parties 13

GlaxoSmithKline Biologicals

Sponsor organisation

GlaxoSmithKline Biologicals

Address

Rue De L'institut 89

City

Rixensart

Postcode

1330

Country

Belgium

Scientific contact point

Organisation

GlaxoSmithKline Biologicals

Contact name

EU GSK Clinical Trial

Public contact point

Organisation

GlaxoSmithKline Biologicals

Contact name

EU GSK Clinical Trial

Third parties 13

Locations

1 EU/EEA country · 6 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications