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NCT05519839 | Not yet recruiting | COVID-19


A Study to Evaluate the Safety and Immunogenicity of COVID-19 and Influenza Combination Vaccine
Sponsor:

Novavax

Brief Summary:

This is a randomized, observer-blinded, Phase 2 study evaluating the safety and immunogenicity of a severe acute respiratory syndrome coronavirus 2 (SARSCoV2) recombinant spike (rS) (SARS-CoV-2 rS) nanoparticle and quadrivalent hemagglutinin (HA) nanoparticle influenza vaccine (qNIV) combination vaccine with Matrix-M™ adjuvant; this combination vaccine.

Condition or disease

COVID-19

Influenza

Intervention/treatment

CIC Vaccine

CIC Vaccine

qNIV Vaccine

SARS-CoV-2 rS Vaccine

Influenza Vaccine

CIC Vaccine

Phase

Phase 2

Study Type : Interventional
Estimated Enrollment : 2300 participants
Masking: Triple
Primary Purpose: Prevention
Official Title: A Phase 2, Randomized, Observer-Blinded Study to Evaluate the Safety and Immunogenicity of a SARS-CoV-2 rS Nanoparticle and Quadrivalent Hemagglutinin Nanoparticle Influenza Combination Vaccine With Matrix-M™ Adjuvant in Healthy Participants ≥ 50 to ≤ 80 Years of Age
Actual Study Start Date : January 16, 2023
Estimated Primary Completion Date : July 31, 2023
Estimated Study Completion Date : July 31, 2023
Arm Intervention/treatment

Experimental: Group A (Part 1)

CIC Vaccine Formulation 1 doses of Formulation 1. 1 dose on Days 0.

Drug: CIC Vaccine

Experimental: Group B (Part 1)

CIC Vaccine Formulation 1 doses of Formulation 2. 1 dose on Days 0.

Drug: CIC Vaccine

Experimental: Group C (Part 1)

CIC Vaccine Formulation 1 doses of Formulation 3. 1 dose on Days 0.

Drug: CIC Vaccine

Experimental: Group D (Part 1)

CIC Vaccine Formulation1 doses of Formulation 4. 1 dose on Days 0.

Drug: CIC Vaccine

Experimental: Group E (Part 1)

CIC Vaccine Formulation 1 doses of Formulation 5. 1 dose on Days 0.

Drug: CIC Vaccine

Experimental: Group F (Part 1)

CIC Vaccine Formulation 1 doses of Formulation 6. 1 dose on Days 0.

Drug: CIC Vaccine

Experimental: Group G (Part 1)

CIC Vaccine Formulation 1 doses of Formulation 7. 1 dose on Days 0.

Drug: CIC Vaccine

Experimental: Group H (Part 1)

CIC Vaccine Formulation 1 doses of Formulation 8. 1 dose on Days 0.

Drug: CIC Vaccine

Experimental: Group I (Part 1)

CIC Vaccine Formulation 1 doses of Formulation 9. 1 dose on Days 0.

Drug: CIC Vaccine

Experimental: Group J (Part 1)

CIC Vaccine Formulation 1 doses of Formulation 10. 1 dose on Days 0.

Drug: CIC Vaccine

Experimental: Group K (Part 1)

CIC Vaccine Formulation 1 doses of Formulation 11. 1 dose on Days 0.

Drug: CIC Vaccine

Experimental: Group L (Part 1)

qNIV Vaccine Formulation 1 doses of Formulation 12. 1 dose on Days 0.

Drug: qNIV Vaccine

Experimental: Group M (Part 1)

qNIV Vaccine Formulation 1 doses of Formulation 13. 1 dose on Days 0.

Drug: qNIV Vaccine

Experimental: Group N (Part 1)

CIC Vaccine Formulation 1 doses of Formulation 14. 1 dose on Days 0.

Drug: qNIV Vaccine

Experimental: Group O (Part 1)

SARS-CoV-2 rS Vaccine Formulation 1 doses of Formulation 15. 1 dose on Days 0.

Drug: SARS-CoV-2 rS Vaccine

Experimental: Group P (Part 1)

Reference Vaccine Formulation 1 doses of Formulation 16. 1 dose on Days 0.

Drug: SARS-CoV-2 rS Vaccine

Experimental: Group Q (Part 1)

Reference Vaccine Formulation 1 doses of Formulation 17. 1 dose on Days 0.

Drug: SARS-CoV-2 rS Vaccine

Experimental: Group R (Part 1)

Reference Vaccine Formulation 1 doses of Formulation 18. 1 dose on Days 0.

Drug: SARS-CoV-2 rS Vaccine

Experimental: Group S (Part 1)

Comparator Influenza Vaccine Formulation 1 doses of Formulation 19. 1 dose on Days 0.

Drug: Influenza Vaccine

Experimental: Group T (Part 1)

Comparator Influenza Vaccine Formulation 1 doses of Formulation 20. 1 dose on Days 0.

Drug: Influenza Vaccine

Experimental: Group U (Part 2)

CIC Vaccine Formulation 1 doses of Formulation 1. 1 dose on Days 0.

Drug: CIC Vaccine

Experimental: Group V (Part 2)

CIC Vaccine Formulation 1 doses of Formulation 2. 1 dose on Days 0.

Drug: CIC Vaccine

Ages Eligible for Study: 50 Years to 80 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
Inclusion Criteria
  • To be included in this study, each individual must satisfy all the following criteria
    • Medically stable adult male or females ≥ 50 to ≤ 80 years of age at screening.
    • Participants may have 1 or more chronic medical diagnoses, but should be clinically stable as assessed by
      • Absence of changes in medical therapy in the past 2 months due to treatment failure or toxicity;
      • Absence of medical events qualifying as SAEs within 3 months; and
      • Absence of known, current, and life-limiting diagnoses which render survival to completion of the protocol unlikely in the opinion of the investigator.
      • The participant has a body mass index (BMI) of 17 to 40 kg/m2, inclusive, at screening.
      • Willing and able to give informed consent prior to study enrollment.
      • Able to attend study visits, comply with study requirements, and provide reliable and complete reports of AEs.
      • Participants must have completed a primary vaccination series against SARS-CoV-2 with an authorized COVID 19 vaccine (and fulfill national recommendations for his/her age and morbidity category) with receipt of second/last dose of authorized vaccine (with or without boosters[s]) ≥ 8 weeks prior to enrollment (first study vaccination).
      • Women of childbearing potential (defined as any female participant who is NOT surgically sterile [ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at least 12 consecutive months]) must agree to be heterosexually inactive from at least 28 days prior to enrollment and through the end of the study OR agree to consistently use a medically acceptable method of contraception listed below from at least 28 days prior to enrollment and through the end of the study
      • Condoms (male or female) with spermicide (if acceptable in country)
      • Diaphragm with spermicide
      • Cervical cap with spermicide
      • Intrauterine device
      • Oral or patch contraceptives
      • Norplant®, Depo-Provera®, or other in-country regulatory approved contraceptive method that is designed to protect against pregnancy
      • Abstinence, as a form of contraception, is acceptable if in line with the participant's lifestyle
      • Participants must be healthy and medically stable, as determined by the investigator (based on review of health status, vital signs [to include body temperature], medical history, and targeted physical examination [to include body weight]). Vital signs must be within medically acceptable ranges prior to vaccination.
      • Participants must agree to not participate in any other SARS-CoV-2 or influenza prevention or treatment studies for the duration of the study. Note: For participants who become hospitalized with COVID-19, participation in investigational treatment studies is permitted.
      Exclusion Criteria
      • If an individual meets any of the following criteria, he or she is ineligible for this study
        • History of laboratory-confirmed (by Polymerase Chain Reaction (PCR) or rapid antigen test) COVID-19 or asymptomatic SARS-CoV-2 infection ≤ 8 weeks prior to enrollment.
        • (NOTE: Symptomatic COVID-19 or asymptomatic SARS-CoV-2 infection > 8 weeks prior to enrollment is NOT exclusionary)
        • Any ongoing, symptomatic acute illness requiring medical or surgical care or chronic illness that required changes in medication in the past 2 months indicating that chronic illness/disease is not stable (at the discretion of the investigator). This includes any current workup of undiagnosed illness that could lead to a new condition.
        • Serious chronic diseases inclusive of
          • Uncontrolled hypertension (NOTE: well controlled hypertension ≤ grade 2 in NOT exclusionary);
          • Congestive heart failure with a history of an acute exacerbation of any severity in the prior 2 years (NOTE
            • mild well-controlled congestive heart failure is NOT exclusionary);
            • Chronic obstructive pulmonary disease (COPD) with a history of an acute exacerbation of any severity in the prior 2 years (NOTE: mild well-controlled COPD is NOT exclusionary);
            • In the past 3 months, evidence of unstable coronary artery disease as manifested by cardiac interventions (eg, cardiac stent placement, coronary artery bypass grafting [CABG]) surgery, new cardiac medications for control of symptoms, or unstable angina (NOTE: stable coronary heart disease is NOT exclusionary);
            • Asthma with a history of exacerbation in the prior 2 years or worsening of asthma symptoms or requiring changes in asthma control medications in the past 2 months (NOTE: well-controlled asthma is NOT exclusionary).
            • Type 1 or type 2 diabetes (adult onset) requiring insulin (NOTE: non-insulin dependent type 2 diabetes is NOT exclusionary);
            • Chronic kidney disease/renal insufficiency;
            • Chronic gastrointestinal and hepatic diseases; or
            • Chronic neurological diseases (such as multiple sclerosis, dementia, Parkinson's disease, degenerative neurological conditions, neuropathy, or epilepsy), history of stroke within 12 months with residual symptoms, or previous neurological disorder within 12 months with residual symptoms (NOTE: history of migraine or chronic headaches or nerve root compression that have been stable on treatment for the last 4 weeks are NOT exclusionary).
            • Participation in research involving an investigational product (drug/biologic/device) within 90 days before planned date of vaccination.
            • Use of COVID-19 prophylactic or treatment monoclonal antibodies or antibody cocktails within 90 days prior to planned date of vaccination.
            • History of a serious reaction to prior influenza vaccination or known allergy to constituents of influenza vaccines - including egg proteins - or polysorbate 80; or any known allergies to products contained in the investigational product.
            • Any history of anaphylaxis to any prior vaccine.
            • History of Guillain-Barré Syndrome within 6 weeks following a previous influenza vaccine.
            • Receipt of any vaccine in the 4 weeks preceding the study vaccination and any influenza vaccine within 8 weeks preceding the study vaccination. Note: Routine vaccinations will not be allowed until after study Day 21 and COVID and influenza vaccination will not be allowed until after Day 84.
            • Any known or suspected autoimmune or immunosuppressive illness, congenital or acquired, based on medical history and/or physical examination (NOTE: mild psoriasis is not exclusionary).
            • Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune- modifying drugs within 6 months prior to the administration of the study vaccines. An immunosuppressant dose of glucocorticoid is defined as a systemic dose ≥ 10 mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids is permitted.
            • Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study.
            • Active cancer (malignancy) therapy within 3 years prior to study vaccination (with the exception of adequately treated non-melanomatous skin carcinoma or lentigo maligna and uterine cervical carcinoma in situ without evidence of disease, at the discretion of the investigator).
            • Participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the end of study (EoS).
            • Known disturbance of coagulation.
            • Suspected or known history of alcohol abuse or drug addiction within 2 years prior to study vaccination, which in the opinion of the investigator, might interfere with protocol compliance.
            • Acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever, or an oral temperature > 38.0°C, on the planned day of vaccine administration).
            • History of myocarditis or pericarditis.
            • Any condition that in the opinion of the investigator would pose a health risk to the participant if enrolled or could interfere with evaluation of the vaccine or interpretation of study results (including neurologic or psychiatric conditions deemed likely to impair the quality of safety reporting).
            • Study team member or immediate family member of any study team member (inclusive of Sponsor, Contract Research Organization, and study site personnel involved in the conduct or planning of the study.

A Study to Evaluate the Safety and Immunogenicity of COVID-19 and Influenza Combination Vaccine

Location Details


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A Study to Evaluate the Safety and Immunogenicity of COVID-19 and Influenza Combination Vaccine

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Not yet recruiting

Australia, Australian Capital Territory

Paratus Clinical Research - Canberra

Bruce, Australian Capital Territory, Australia,

Not yet recruiting

Australia, New South Wales

Emeritus Research - Sydney

Botany, New South Wales, Australia,

Not yet recruiting

Australia, New South Wales

Northern Beaches Clinical Research

Brookvale, New South Wales, Australia,

Not yet recruiting

Australia, New South Wales

Holdsworth House Medical Brisbane

Darlinghurst, New South Wales, Australia,

Not yet recruiting

Australia, New South Wales

Paratus Clinical Research - Central Coast

Kanwal, New South Wales, Australia,

Not yet recruiting

Australia, New South Wales

Australian Clinical Research Network

Maroubra, New South Wales, Australia,

Not yet recruiting

Australia, New South Wales

Hunter Diabetes Centre

Merewether, New South Wales, Australia,

Not yet recruiting

Australia, Queensland

Paratus Clinical Research - Brisbane Clinic

Albion, Queensland, Australia,

Not yet recruiting

Australia, Queensland

Mater Adult Hospital

Brisbane, Queensland, Australia,

Not yet recruiting

Australia, Queensland

Nucleus Network Pty Ltd

Herston, Queensland, Australia,

Not yet recruiting

Australia, Queensland

Core Research Group

Milton, Queensland, Australia,

Not yet recruiting

Australia, Queensland

Austrials Pty Ltd - Taringa

Taringa, Queensland, Australia,

Not yet recruiting

Australia, Queensland

AusTrials (Wellers Hill)

Tarragindi, Queensland, Australia,

Not yet recruiting

Australia, South Australia

CMAX

Adelaide, South Australia, Australia,

Not yet recruiting

Australia, Victoria

Emeritus Research

Camberwell, Victoria, Australia,

Not yet recruiting

Australia, Victoria

Nucleus Network Limited

Melbourne, Victoria, Australia,

Not yet recruiting

New Zealand,

Middlemore Clinical Trials

Auckland, New Zealand,

Not yet recruiting

New Zealand,

Optimal Clinical Trials Ltd

Auckland, New Zealand,

Not yet recruiting

New Zealand,

New Zealand Clinical Research - Christchurch

Christchurch, New Zealand,

Not yet recruiting

New Zealand,

P3 Research - Tauranga

Tauranga, New Zealand,

Not yet recruiting

New Zealand,

P3 Research - Wellington

Wellington, New Zealand,

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