The goal of Phase 3 Study is Comparing the Safety and Immune Response of Three Batches ofa COVID-19 and Flu Combination Vaccine in Seniors Aged 65+
This is a randomized, Phase 3 study comparing the safety and immunogenicity of 3
different lots of Novavax coronavirus disease 2019 (COVID-19) and influenza combination
(CIC) vaccine in terms of wild-type influenza hemagglutinin inhibition (HAI) antibody
responses to 3 vaccine-homologous influenza strains (i.e., 2 influenza A strains and an
influenza B-Victoria lineage strain) and 1 IM dose of Fluzone HD in terms of the
neutralizing antibody (NAb) responses to the homologous severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2) strain.
Biological: coformulated CIC Vaccine
SARS-CoV-2 rS (35 µg) + trivalent hemagglutinin nanoparticle influenza (tNIV) antigen
(180 µg; 60 µg per strain) + Matrix-M adjuvant (75 µg)
Other Name: SARS-CoV-2 rS, tNIV, Matrix-M adjuvant
Biological: Fluzone HD trivalent
60 µg per strain of 3 strains (sodium phosphate buffered isotonic sodium chloride
solution + formaldehyde and octyl phenol ethoxylate)
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 ≥ 60 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 either 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. Participants must agree to not participate in any other SARS-CoV-2 or influenza
prevention or treatment studies for the duration of the study.
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] or rapid antigen
test) COVID-19 or asymptomatic SARS-CoV-2 infection; either occurring ≤ 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;
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;
4. Within 3 months prior to Screening, evidence of unstable coronary artery
disease as manifested by cardiac interventions (e.g., cardiac stent placement,
coronary artery bypass graft surgery), new cardiac medications for control of
symptoms, or unstable angina.
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.
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 within 6 weeks 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 28 and COVID-19 and influenza
vaccination will not be allowed until after Day 28.
10. Any known or suspected autoimmune or immunosuppressive illness, congenital or
acquired, based on medical history and/or physical examination.
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
malign and uterine cervical carcinoma in situ without evidence of disease, at the
discretion of the Investigator).
14. Women of childbearing potential (defined as any female participant who is NOT
surgically sterile [i.e., hysterectomy, bilateral tubal ligation, or bilateral
oophorectomy] or postmenopausal [defined as amenorrhea at least 12 consecutive
months].
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 [CRO], and study site personnel involved in
the conduct or planning of the study).
Not Provided
Not Provided