Study VBT00002 is planned to be a Phase 1/2, randomized, modified double-blind,active-controlled, multi-center study to be conducted in approximately 980 adults aged 50years and older in the United States. The purpose of the study is to assess the safetyand immunogenicity of recombinant influenza vaccine (RIV) + adjuvanted recombinantCOVID-19 vaccine (rC19) vaccine comprised of RIV combined with different recombinantSpike (rS) antigen levels of rC19 compared to RIV alone, rC19 (dose 1) alone, and RIV andrC19 (dose 1) (coadministered in opposite arms). Placebo will be coadministered in theRIV alone, rC19 (dose 1) alone, and RIV + rC19 study groups to control for the number ofinjections and to maintain observer blinding. Thus, each participant will receive twoinjections at enrollment, one in each deltoid muscle.Study details include: - The study duration will be approximately 12 months - Study intervention will be administered via a single intramuscular (IM) injection into the right and left deltoid muscles on Day(D) 01 - Dose escalation with sequential enrollment (sentinel cohort followed by main cohort for a given dose) - The visit frequency for participants will be D01 and D30, and D09-D366 (telephone call)Number of Participants:Approximately 980 participants are expected to be randomized.
Not Provided
Biological: RIV (recombinant influenza vaccine)
Influenza, inactivated, split virus or surface antigen
Other Name: Recombinant influenza vaccine
Biological: rC19 (dose 1)
Protein subunit
Other Name: Novavax's adjuvanted recombinant COVID-19
Biological: RIV + rC19 (dose 1)
RIV component: Influenza, inactivated, split virus or surface antigen NVXC19 component:
Protein subunit
Biological: RIV + rC19 (dose 2)
RIV component: Influenza, inactivated, split virus or surface antigen NVXC19 component:
Protein subunit
Biological: RIV + rC19 (dose 3)
RIV component: Influenza, inactivated, split virus or surface antigen NVXC19 component:
Protein subunit
Biological: RIV + rC19 (dose 4)
RIV component: Influenza, inactivated, split virus or surface antigen NVXC19 component:
Protein subunit
Other: Placebo (0.9% NaCl)
Normal saline
Inclusion Criteria:
Inclusion criteria to be checked at Screening Visit:
- Aged 50 years or older on the day of inclusion Informed consent
- Informed consent form has been signed and dated.
- Able to attend all scheduled visits and to comply with all study procedures.
- Participant must be able to receive an injection in the deltoid muscle of both arms.
- Participant must have completed a primary vaccination series against SARS-CoV-2 and
at least 1 booster with a locally authorized or approved COVID-19 vaccine.
Inclusion criteria to be checked at Visit 1 (Day [D]01):
- Aged 50 years or older on the day of inclusions
- Participants who are healthy or with pre-existing stable condition (defined as
disease not requiring significant change in therapy or hospitalization for worsening
disease during the 12 weeks before enrollment), as determined by medical evaluation
including medical history and physical examination.
- A female participant is eligible to participate if she is not pregnant or
breastfeeding and one of the following conditions applies:
- Is of non-childbearing potential. To be considered of non-childbearing
potential, a female must be post-menopausal for at least 1 year, or surgically
sterile.
OR
• Is of childbearing potential and agrees to use an effective contraceptive method or
abstinence from at least 4 weeks prior to study intervention administration until at
least 4 weeks after study intervention administration.
A female participant of childbearing potential must have a negative highly sensitive
pregnancy test (urine or serum as required by local regulation) on the day of enrollment
before the first dose of study intervention.
- Informed consent form has been signed and dated.
- Able to attend all scheduled visits and to comply with all study procedures.
- Participant must be able to receive an injection in the deltoid muscle of both arms.
- Participant must have completed a primary vaccination series against SARS-CoV-2 and
at least 1 booster with a locally authorized or approved COVID-19 vaccine.
Exclusion Criteria to be checked at Screening Visit and at Visit 1 (D01):
- Known or suspected congenital or acquired immunodeficiency; or receipt of
immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy,
within the preceding 6 months; or long-term systemic corticosteroid therapy (for
glucocorticoids, ≥ 10 milligrams/day of prednisone or equivalent for more than 2
consecutive weeks within the past 3 months).
- Known systemic hypersensitivity to any of the study intervention components, or
history of a life-threatening reaction to the study interventions used in the study
or to a product containing any of the same substances .
- Self-reported thrombocytopenia, contraindicating intramuscular injection, based on
investigator's judgment.
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,
contraindicating intramuscular injection, based on investigator's judgment.
- Chronic illness that, in the opinion of the investigator, is at a stage where it
might interfere with study conduct or completion .
- Any illness that, in the opinion of the investigator, would pose a health risk to
the participant if enrolled.
- Moderate or severe acute illness/infection (according to investigator judgment) or
febrile illness (temperature ≥ 100.4°F) on the day of study intervention
administration. A prospective participant should not be included in the study until
the condition has resolved or the febrile event has subsided.
- Alcohol, prescription drug, or substance abuse that, in the opinion of the
Investigator, might interfere with the study conduct or completion.
- History of serious adverse reaction to any influenza or COVID-19 vaccines.
- Personal or family history of Guillain-Barré syndrome.
- Prior history of myocarditis, pericarditis, or myopericarditis.
- Prior history of stroke or stroke risk factors, which may include
untreated/uncontrolled hypertension, hyperlipidemia, or diabetes; active smoking;
obesity, based on investigator's judgment; history of thromboembolic disease;
cardiac structural abnormality; atrial fibrillation; carotid stent placement; or
family history of stroke.
Prior/concomitant therapy
- Receipt of any vaccine in the 4 weeks preceding study intervention administration or
planned receipt of any vaccine prior to the second blood draw (ie, approximately in
the 28 days following study intervention administration.
- Previous vaccination against influenza (in the previous 6 months) with an
investigational or marketed vaccine.
- Previous vaccination against COVID-19 (in the previous 6 months) with an
investigational or marketed vaccine OR history of COVID-19 in the previous 6 months.
- Receipt of immune globulins, blood or blood-derived products in the past 3 months
Central Phoenix Medical Clinic- Site Number : 8400009
Phoenix, Arizona, United States
Synexus Clinical Research US, Inc. - Cerritos- Site Number : 8400002
Cerritos, California, United States
Synexus Clinical Research US - Vista- Site Number : 8400010
Vista, California, United States
Optimal Research - Florida- Site Number : 8400006
Melbourne, Florida, United States
Synexus Clinical Research US - Orlando- Site Number : 8400007
Orlando, Florida, United States
Optimal Research - Illinois- Site Number : 8400008
Peoria, Illinois, United States
Synexus Clinical Research US - Evansville- Site Number : 8400004
Evansville, Indiana, United States
Walgreens Clinical Trials-Malden- Site Number : 8400012
Malden, Massachusetts, United States
Synexus Clinical Research US - Minneapolis- Site Number : 8400011
Richfield, Minnesota, United States
Synexus-Las Vegas- Site Number : 8400005
Las Vegas, Nevada, United States
Synexus Clinical Research US - Cincinnati- Site Number : 8400003
Cincinnati, Ohio, United States
Synexus Clinical Research US - Anderson- Site Number : 8400001
Anderson, South Carolina, United States
Not Provided