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 8349301, Australian Capital Territory 2177478, Australia
Momentum Wellers
Wellers Hill 2144173, Brisbane, Australia
Paratus Clinical Research - Western Sydney - PPDS
Blacktown 2175411, New South Wales 2155400, Australia
Key Health- Bondi Junction
Bondi Junction 8555644, New South Wales 2155400, Australia
Emeritus Research - Sydney - PPDS
Botany 2174563, New South Wales 2155400, Australia
Genesis Research Services
Broadmeadow 10103838, New South Wales 2155400, Australia
Northern Beaches Clinical Research - PPDS
Brookvale 2208303, New South Wales 2155400, Australia
Northside Health
Coffs Harbour 2171085, New South Wales 2155400, Australia
East Sydney Doctors
Darlinghurst 2169378, New South Wales 2155400, Australia
Momentum Darlinghurst
Darlinghurst 2169378, New South Wales 2155400, Australia
Oztrials Clinical Research
Drummoyne 2207783, New South Wales 2155400, Australia
Paratus Clinical Research - Central Coast - PPDS
Kanwal 2161863, New South Wales 2155400, Australia
Novatrials
Kotara 2161029, New South Wales 2155400, Australia
Australian Clinical Research Network
Maroubra 2158651, New South Wales 2155400, Australia
Hunter Diabetes Centre
Merewether 8348074, New South Wales 2155400, Australia
Sutherland Shire Clinical Research - PPDS
Miranda 2157495, New South Wales 2155400, Australia
Pioneer Clinical Research - North Sydney
North Sydney 2154855, New South Wales 2155400, Australia
Taylor Square Private Clinic
Surry Hills 2147821, New South Wales 2155400, Australia
Momentum St Leonards
Sydney 2147714, New South Wales 2155400, Australia
Innovate Clinical Research Pty Ltd
Sydney 2147714, New South Wales 2155400, Australia
Wollongong Clinical Research - PPDS
Wollongong 2171507, New South Wales 2155400, Australia
Menzies School of Health Research
Casuarina 8349383, Northern Territory 2064513, Australia
University of the Sunshine Coast, Vitality Village - UniSC Clinical Trials - PPDS
Birtinya 8348723, Queensland 2152274, Australia
Momentum Taringa
Brisbane 2174003, Queensland 2152274, Australia
Griffith University Clinical Trials Unit
Griffith, Queensland 2152274, Australia
Nucleus Network Pty Ltd
Herston 6931014, Queensland 2152274, Australia
Paratus Clinical Research - Brisbane Clinic - PPDS
Herston 6931014, Queensland 2152274, Australia
Mater Hospital Brisbane
South Brisbane 2207259, Queensland 2152274, Australia
Cmax - Ppds
Adelaide 2078025, South Australia 2061327, Australia
Veritus Research - Emeritus - PPDS
Bayswater 2176566, Victoria 2145234, Australia
Emeritus Research -PPDS
Camberwell 2172686, Victoria 2145234, Australia
Ryrie St, Geelong, VIC 3220, Australia
Geelong 2165798, Victoria 2145234, Australia
Doherty Clinical Trials Limited
Melbourne 2158177, Victoria 2145234, Australia
Nucleus Network Limited
Melbourne 2158177, Victoria 2145234, Australia
Momentum Sunshine
Melbourne 2158177, Victoria 2145234, Australia
University of Melbourne - Melbourne
Melbourne N., Victoria 2145234, Australia
Institute for Respiratory Health - Midland
Midland 2066338, Western Australia 2058645, Australia
Telethon Kids Institute
Nedlands 2064874, Western Australia 2058645, Australia
CliniTrials
Perth 2063523, Western Australia 2058645, Australia
Momentum Tauranga - PPDS
Tauranga 2208032, Bay of Plenty 2182560, New Zealand
Momentum Hawke's Bay - PPDS
Hastings 2190224, Hawke's Bay Region 2190146, New Zealand
Momentum Dunedin - PPDS
Dunedin 2191562, Otago 6612109, New Zealand
Southern Clinical Trials - Totara - PCRN - PPDS
Auckland 2193733, New Zealand
Pacific Clinical Research Network - Auckland - PCRN - PPDS
Auckland 2193733, New Zealand
Optimal Clinical Trials Ltd - North Shore - PPDS
Auckland 2193733, New Zealand
Optimal Clinical Trials Ltd - PPDS
Auckland 2193733, New Zealand
Momentum Pukekohe - PPDS
Auckland 2193733, New Zealand
New Zealand Clinical Research - Christchurch - PPDS
Christchurch 2192362, New Zealand
Pacific Clinical Research Network - Christchurch - PCRN - PPDS
Christchurch 2192362, New Zealand
Lakeland Clinical Trials - Waikato - PCRN-PPDS
Hamilton 2190324, New Zealand
Momentum Lower Hutt - PPDS
Lower Hutt 2188164, New Zealand
Southern Clinical Trials - Tasman - PCRN - PPDS
Nelson 2186280, New Zealand
Momentum Palmerston North - PPDS
Palmerston North 2185018, New Zealand
Pacific Clinic Research Network - Rotorua - PCRN - PPDS
Rotorua 6241325, New Zealand
Momentum Kapiti - PPDS
Waikanae 2180320, New Zealand
Lakeland Clinical Trials - Wellington - PCRN - PPDS
Wellington 2179537, New Zealand
Momentum Wellington - PPDS
Wellington 2179537, New Zealand
Aotearoa Clinical Trials Trust
Wellington 2179537, New Zealand
Clinical Development, Study Director
Novavax, Inc.