Official Title
A Phase 3, Randomized, Observer-Blinded, Study to Compare the Safety and Immunogenicity of 3 Lots of Trivalent Hemagglutinin Nanoparticle Influenza Vaccine With Matrix M™ Adjuvant in Participants ≥ 60 Years of Age
Brief Summary

Phase 3 Study Comparing Safety and Immune Response of Three Batches of Novavax FluVaccine in older adult participants

Detailed Description

This is a randomized, Phase 3 study comparing the safety and immunogenicity of 3
different lots of Novavax trivalent hemagglutinin (HA) nanoparticle influenza vaccine
(NIV) with Matrix-M (tNIV) in terms of wild-type influenza hemagglutinin inhibition (HAI)
antibody responses to 3 vaccine-homologous influenza strains (ie, 2 influenza A strains
and an influenza B-Victoria lineage strain).

Withdrawn
COVID-19

Biological: tNIV 1 and Matrix-M Adjuvant

tNIV will be administered as a single 0.5 mL IM injection Day 0
Other Name: Influenza vaccine

Eligibility Criteria

Inclusion Criteria:

- To be included in this study, each individual must satisfy all of 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 at least one
arm.

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

7. 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.

1. Condoms (male or female) with spermicide (if acceptable in country)

2. Diaphragm with spermicide

3. Cervical cap with spermicide

4. Intrauterine device

5. Oral or patch contraceptives

6. Norplant®, Depo-Provera®, or other in-country regulatory approved
contraceptive method that is designed to protect against pregnancy

7. Abstinence as a form of contraception, is acceptable if in line with the
participant's lifestyle

8. Participants must agree to not participate in any other severe acute
respiratory syndrome coronavirus 2 (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. 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.

2. 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 (NOTE: stable congestive heart failure is NOT exclusionary);

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. (f or 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.

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

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

5. 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.

6. Any history of anaphylaxis to any prior vaccine.

7. History of Guillain-Barré Syndrome within 6 weeks following a previous
influenza vaccine.

8. 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.

9. 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).

10. 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.

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

12. 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).

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

14. 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.

15. 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).

16. 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).

17. 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).

Eligibility Gender
All
Eligibility Age
Minimum: 60 Years ~ Maximum: 75 Years
Locations

Not Provided

Not Provided

NCT Number
Keywords
COVID-19, influenza Vaccine
MeSH Terms
COVID-19
Influenza, Human
Vaccines