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

NCT ID: NCT06291857

Last Updated: 2025-07-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 9320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-09
• Study Completion Date: 2026-09-30

Brief Summary

This is a medical study where participants will be randomly assigned to receive either a new combination vaccine that protects against both COVID-19 and the flu, or a standard flu vaccine. The researchers conducting the study won't know which vaccine each participant receives, ensuring their observations are unbiased. This study compares the new combination vaccine to an already available flu vaccine to see how well it works. It's a large-scale, final-stage study designed to thoroughly check how well the vaccines trigger an immune response (immunogenicity) and how safe they are.

Detailed Description

The study will enroll up to approximately 7,022,000 medically stable (based on history and physical examination) adult male and female participants ≥ 65 65 years of age in Part 1 and up to approximately 2,300 medically stable (based on history and physical examination) adult male and female participants ≥ 65 years of age in Part 2. In Part 1, pParticipants will be randomly assigned to receive either CIC, Novavax COVID-19 Vaccine, tNIV, or Fluzone High-Dose in a 3:2:1:3 ratio, respectively. All participants will receive a single intramuscular (IM) injection on Day 0, will remain on study for immunogenicity data collection through Day 182 and safety data collection through Day 364 (End of Study [EoS]).

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

CIC Vaccine

A single 0.5 mL IM injection on Day 0

Group Type: EXPERIMENTAL

CIC Vaccine Co-formulated tNIV2 , SARSCoV-2 rS and Matrix-M Adjuvant

Intervention Type: BIOLOGICAL

CIC will contain SARs-CoV-2 antigen (35 μg), tNIV antigens (2 influenza A \[H1N1 and H3N2\] and 1 influenza B-Victoria lineage strains; 60 μg/strain

Novavax COVID-19 Vaccine

A single 0.5 mL IM injection on Day 0

Group Type: EXPERIMENTAL

Novavax COVID-19 Vaccine

Intervention Type: BIOLOGICAL

Each 0.5 mL dose comprises 5 µg SARS-CoV-2 S protein and 50 µg Matrix-M adjuvant

tNIV Vaccine

A single 0.5 mL IM injection on Day 0

Group Type: EXPERIMENTAL

tNIV Vaccine

Intervention Type: BIOLOGICAL

2 influenza A \[H1N1 and H3N2\] and 1 influenza B-Victoria lineage strains (60 μg/strain), and Matrix-M adjuvant (75 μg)

Fluzone High-Dose

A single 0.5 mL IM injection on Day 0

Group Type: EXPERIMENTAL

Fluzone High Dose

Intervention Type: BIOLOGICAL

Fluzone High-Dose is supplied as a suspension for IM injection 0.5 mL with 60 µg per strain

Interventions

CIC Vaccine Co-formulated tNIV2 , SARSCoV-2 rS and Matrix-M Adjuvant

CIC will contain SARs-CoV-2 antigen (35 μg), tNIV antigens (2 influenza A \[H1N1 and H3N2\] and 1 influenza B-Victoria lineage strains; 60 μg/strain

Intervention Type: BIOLOGICAL

Novavax COVID-19 Vaccine

Each 0.5 mL dose comprises 5 µg SARS-CoV-2 S protein and 50 µg Matrix-M adjuvant

Intervention Type: BIOLOGICAL

tNIV Vaccine

2 influenza A \[H1N1 and H3N2\] and 1 influenza B-Victoria lineage strains (60 μg/strain), and Matrix-M adjuvant (75 μg)

Intervention Type: BIOLOGICAL

Fluzone High Dose

Fluzone High-Dose is supplied as a suspension for IM injection 0.5 mL with 60 µg per strain

Intervention Type: BIOLOGICAL

Other Intervention Names

COVID-19 and influenza combination; Novavax SARS-CoV-2 rS vaccine; Trivalent Nanoparticle Influenza Hemagglutinin Vaccine; Fluzone HD

Eligibility Criteria

Inclusion Criteria

To be included in this study, each individual must satisfy all the following criteria:

1. Willing and able to give informed consent prior to study enrollment.

2. Medically stable adult male or female ≥ 65 years of age at Screening.

3. Participants may have 1 or more chronic medical diagnoses, but should be clinically stable as assessed by:

1. Absence of changes in medical therapy in the past 2 months due to treatment failure or toxicity;

2. Absence of medical events qualifying as SAEs within 3 months; and

3. Absence of known, current, and life-limiting diagnoses which render survival to completion of the protocol unlikely in the opinion of the Investigator.

4. The participant has a body mass index (BMI) of 17 to 40 kg/m2, inclusive, at Screening.

5. Participant must be able to receive an injection in the deltoid of at least 1 arm.

6. Able to attend study visits, comply with study requirements, and provide reliable and complete reports of AEs.

7. Participants must have completed a primary vaccination series/booster against SARS CoV-2 with an authorized/approved COVID-19 vaccine, with receipt of last dose of authorized/approved vaccine (with or without boosters[s]) ≥ 8 weeks prior to vaccination.

8. Female participants must be surgically sterile (ie, have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or postmenopausal (defined as amenorrhea at least 12 consecutive months)

9. 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 or influenza, 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:

1. History of laboratory-confirmed (by polymerase chain reaction [PCR], rapid antigen test, or rapid molecular assay) COVID-19, asymptomatic SARS-CoV-2 infection, or influenza within ≤ 8 weeks prior to Screening.

2. Any ongoing, symptomatic acute illness requiring medical or surgical care or chronic illness that required substantive changes in medication in the past 2 months prior to Screening 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.

3. Serious chronic diseases inclusive of:

1. Uncontrolled hypertension (NOTE: hypertension ≤ 170/100 is NOT exclusionary);

2. Congestive heart failure requiring hospitalization within 3 months prior to Screening

3. Chronic obstructive pulmonary disease (COPD) requiring hospitalization within 3 months prior to Screening (NOTE: stable COPD is NOT exclusionary);

4. Within 3 months prior to Screening, evidence of unstable coronary artery disease as manifested by cardiac interventions (eg, cardiac stent placement, coronary artery bypass graft surgery), new cardiac medications for control of symptoms, or unstable angina (NOTE: stable coronary heart disease is NOT exclusionary);

5. Hospitalization for diabetic ketoacidosis within 6 months prior to Screening

6. Chronic kidney disease/renal requiring institution of substantive new therapy within 3 months prior to Screening

7. Chronic clinically significant gastrointestinal and hepatic diseases requiring hospitalization or institution of substantive new therapy within 3 months prior to Screening. (for example, gastroesophageal reflux disease is NOT exclusionary)

8. Chronic neurological diseases or neurological compromise preventing access to the study clinic, compliance with protocol, or accurate reporting of safety.

4. Participation in research involving an investigational product (drug/biologic/device) within 90 days before planned date of vaccination.

5. Use of COVID-19 prophylactic or treatment monoclonal antibodies or antibody cocktails within 90 days prior to planned date of vaccination.

6. History of a serious reaction to a 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.

7. Any history of anaphylaxis to any prior vaccine.

8. History of Guillain-Barré Syndrome following a previous influenza vaccine.

9. Receipt of any vaccine in the 4 weeks preceding the study vaccination and any influenza vaccine within 2 months preceding the study vaccination. Note: Routine vaccinations will not be allowed until after study Day 21 and COVID-19 and influenza vaccination will not be allowed until after Day 84.

10. Any known or suspected autoimmune or immunosuppressive illness, congenital or acquired, based on medical history and/or physical examination (NOTE: well-controlled hypothyroidism and mild psoriasis are not exclusionary).

11. 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.

12. Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study.

13. Active cancer (malignancy) therapy within 1 year 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).

14. Participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the EoS.

15. 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.

16. 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).

17. History of myocarditis or pericarditis.

18. 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).

19. 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).

20. Known history of any prior motor neuropathy.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novavax

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Development

Role: STUDY_DIRECTOR

Novavax, Inc.

Locations

Paratus Clinical Research - Canberra - PPDS

Bruce, Australian Capital Territory, Australia

Momentum Wellers

Wellers Hill, Brisbane, Australia

Paratus Clinical Research - Western Sydney - PPDS

Blacktown, New South Wales, Australia

Key Health- Bondi Junction

Bondi Junction, New South Wales, Australia

Emeritus Research - Sydney - PPDS

Botany, New South Wales, Australia

Genesis Research Services

Broadmeadow, New South Wales, Australia

Northern Beaches Clinical Research - PPDS

Brookvale, New South Wales, Australia

Northside Health

Coffs Harbour, New South Wales, Australia

East Sydney Doctors

Darlinghurst, New South Wales, Australia

Momentum Darlinghurst

Darlinghurst, New South Wales, Australia

Oztrials Clinical Research

Drummoyne, New South Wales, Australia

Paratus Clinical Research - Central Coast - PPDS

Kanwal, New South Wales, Australia

Novatrials

Kotara, New South Wales, Australia

Australian Clinical Research Network

Maroubra, New South Wales, Australia

Hunter Diabetes Centre

Merewether, New South Wales, Australia

Sutherland Shire Clinical Research - PPDS

Miranda, New South Wales, Australia

Pioneer Clinical Research - North Sydney

North Sydney, New South Wales, Australia

Taylor Square Private Clinic

Surry Hills, New South Wales, Australia

Momentum St Leonards

Sydney, New South Wales, Australia

Innovate Clinical Research Pty Ltd

Sydney, New South Wales, Australia

Wollongong Clinical Research - PPDS

Wollongong, New South Wales, Australia

Menzies School of Health Research

Casuarina, Northern Territory, Australia

University of the Sunshine Coast, Vitality Village - UniSC Clinical Trials - PPDS

Birtinya, Queensland, Australia

Momentum Taringa

Brisbane, Queensland, Australia

Griffith University Clinical Trials Unit

Griffith, Queensland, Australia

Nucleus Network Pty Ltd

Herston, Queensland, Australia

Paratus Clinical Research - Brisbane Clinic - PPDS

Herston, Queensland, Australia

Mater Hospital Brisbane

South Brisbane, Queensland, Australia

Cmax - Ppds

Adelaide, South Australia, Australia

Veritus Research - Emeritus - PPDS

Bayswater, Victoria, Australia

Emeritus Research -PPDS

Camberwell, Victoria, Australia

Ryrie St, Geelong, VIC 3220, Australia

Geelong, Victoria, Australia

Doherty Clinical Trials Limited

Melbourne, Victoria, Australia

Nucleus Network Limited

Melbourne, Victoria, Australia

Momentum Sunshine

Melbourne, Victoria, Australia

University of Melbourne - Melbourne

Melbourne N., Victoria, Australia

Institute for Respiratory Health - Midland

Midland, Western Australia, Australia

Telethon Kids Institute

Nedlands, Western Australia, Australia

CliniTrials

Perth, Western Australia, Australia

Momentum Tauranga - PPDS

Tauranga, Bay of Plenty, New Zealand

Momentum Hawke's Bay - PPDS

Hastings, Hawke's Bay Region, New Zealand

Momentum Dunedin - PPDS

Dunedin, Otago, New Zealand

Southern Clinical Trials - Totara - PCRN - PPDS

Auckland, , New Zealand

Pacific Clinical Research Network - Auckland - PCRN - PPDS

Auckland, , New Zealand

Optimal Clinical Trials Ltd - North Shore - PPDS

Auckland, , New Zealand

Optimal Clinical Trials Ltd - PPDS

Auckland, , New Zealand

Momentum Pukekohe - PPDS

Auckland, , New Zealand

New Zealand Clinical Research - Christchurch - PPDS

Christchurch, , New Zealand

Pacific Clinical Research Network - Christchurch - PCRN - PPDS

Christchurch, , New Zealand

Lakeland Clinical Trials - Waikato - PCRN-PPDS

Hamilton, , New Zealand

Momentum Lower Hutt - PPDS

Lower Hutt, , New Zealand

Southern Clinical Trials - Tasman - PCRN - PPDS

Nelson, , New Zealand

Momentum Palmerston North - PPDS

Palmerston North, , New Zealand

Pacific Clinic Research Network - Rotorua - PCRN - PPDS

Rotorua, , New Zealand

Momentum Kapiti - PPDS

Waikanae, , New Zealand

Lakeland Clinical Trials - Wellington - PCRN - PPDS

Wellington, , New Zealand

Momentum Wellington - PPDS

Wellington, , New Zealand

Aotearoa Clinical Trials Trust

Wellington, , New Zealand

Countries

Australia; New Zealand

Other Identifiers

CIC-E-301

Identifier Type: -

Identifier Source: org_study_id