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 50 years and older in the United States. The purpose of the study is to assess the safety and immunogenicity of recombinant influenza vaccine (RIV) + adjuvanted recombinant COVID-19 vaccine (rC19) vaccine comprised of RIV combined with different recombinant Spike (rS) antigen levels of rC19 compared to RIV alone, rC19 (dose 1) alone, and RIV and rC19 (dose 1) (coadministered in opposite arms). Placebo will be coadministered in the RIV alone, rC19 (dose 1) alone, and RIV + rC19 study groups to control for the number of injections and to maintain observer blinding. Thus, each participant will receive two injections 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
980
Influenza, inactivated, split virus or surface antigen
Protein subunit
RIV component: Influenza, inactivated, split virus or surface antigen NVXC19 component: Protein subunit
RIV component: Influenza, inactivated, split virus or surface antigen NVXC19 component: Protein subunit
RIV component: Influenza, inactivated, split virus or surface antigen NVXC19 component: Protein subunit
RIV component: Influenza, inactivated, split virus or surface antigen NVXC19 component: Protein subunit
Normal saline
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
...and 2 more locations
Number of participants with immediate adverse events (AEs)
Within the 30 minutes after vaccination
Time frame: Immediate adverse events are any unsolicited systemic adverse events reported in the 30 minutes after vaccination
Number of participants with solicited injection site reactions
Solicited injection site reactions include injection site pain, erythema and swelling
Time frame: Up to 7 each days after vaccination
Number of participants with solicited systemic reactions
Solicited systemic reactions include fever, headache, fatigue, myalgia and chills
Time frame: Up to 7 days after each vaccination
Number of participants with unsolicited AEs
Unsolicited (spontaneously reported) AEs, not fulfilling criteria for solicited adverse reactions
Time frame: Up to 28 days after each vaccination
Number of participants with adverse events of special interest (AESIs)
AESIs
Time frame: Up to 180 days after each vaccination
Number of participants with medical attended adverse events (MAAEs)
MAAEs
Time frame: Up to 180 days after each vaccination
Number of participants with MAAEs relating to predefined PIMDs
MAAEs relating to predefined PIMDs
Time frame: From Day 182 through 12 months following the last study vaccination
Number of participants with serious adverse events (SAEs)
SAEs
Time frame: Up to 180 days after each vaccination
Number of participants with related SAEs
Related SAEs
Time frame: From Day 182 through 12 months following the last study intervention
Number of participants with MAAEs relating to predefined PIMDs that meet the criteria for SAEs
MAAEs relating to predefined PIMDs that meet the criteria for SAEs
Time frame: From Day 182 through 12 months following the last study vaccination
Geometric mean (GM) of HAI titers in all participants
HAI titers
Time frame: At Day 01 and Day 30
Geometric mean ratio (GMR) of HAI titers in all participants
Individual HAI titers ratio Day 30/Day 01
Time frame: At Day 01 and Day 30
GM of SARS-CoV-2 neutralizing titers in all participants
SARS-CoV-2 neutralizing titers
Time frame: At Day 01 and Day 30
GMR of SARS-CoV-2 neutralizing titers ratio D30/D01 in all participants
Individual SARS-CoV-2 neutralizingtiters ratio Day 30/Day 01
Time frame: At Day 01 and Day 30
Percentage of participants with seroconversion in all participants
Seroconversion is defined by:HAI titer \< 10 \[1/dil\] at Day 01 and post-injection titer ≥ 40 \[1/dil\] at Day 30 or HAI titer ≥ 10 \[1/dil\] and a ≥ 4-foldincrease in titer \[1/dil\] at Day 30
Time frame: At Day 30
Percentage of participants with HAI titer ≥ 10 (1/dil) in all participants
detectable HAI titer ≥ 10 (1/dil)
Time frame: At Day 01 and Day 30
Percentage of participants with HAI titer ≥ 40 (1/dil) in all participants
HAI titer ≥ 40 (1/dil)
Time frame: At Day 01 and Day 30
Percentage of participants with seroresponse to SARS-CoV-2 in all participants
Seroresponse to SARS-CoV-2 isdefined by SARS-CoV-2 neutralizingtiters ≥ 4-fold rise in SARS-CoV-2neutralizing titers from Day 01 to Day 30
Time frame: At Day 30
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