This is a medical study where participants will be randomly assigned to receive either anew combination vaccine that protects against both COVID-19 and the flu, or a standardflu vaccine. The researchers conducting the study won't know which vaccine eachparticipant receives, ensuring their observations are unbiased. This study compares thenew 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 vaccinestrigger an immune response (immunogenicity) and how safe they are.
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]).
Biological: 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
Other Name: COVID-19 and influenza combination
Biological: Novavax COVID-19 Vaccine
Each 0.5 mL dose comprises 5 µg SARS-CoV-2 S protein and 50 µg Matrix-M adjuvant
Other Name: Novavax SARS-CoV-2 rS vaccine
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)
Other Name: Trivalent Nanoparticle Influenza Hemagglutinin Vaccine
Biological: Fluzone High Dose
Fluzone High-Dose is supplied as a suspension for IM injection 0.5 mL with 60 µg per
strain
Other Name: Fluzone HD
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.
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
University of Melbourne - Melbourne
Melbourne N., Victoria, Australia
Doherty Clinical Trials Limited
Melbourne, Victoria, Australia
Nucleus Network Limited
Melbourne, Victoria, Australia
Momentum Sunshine
Melbourne, 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, 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
Clinical Development, Study Director
Novavax, Inc.