This is a Phase 4, post-market US study, evaluating the efficacy and safety of a single dose of the NVX-CoV2705 Omicron JN.1 COVID-19 vaccine. Approximately 6,500 healthy adults aged 50 to under 65 will be randomized to receive either the vaccine or a placebo, with follow-up for 180 days.
This is a Phase 4, multicenter, randomized, double-blind, placebo-controlled, post-marketing study to evaluate the efficacy and safety of a single dose of an Omicron JN.1 subvariant severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) recombinant (r) spike (S) protein nanoparticle vaccine (SARS-CoV-2 rS) adjuvanted with Matrix-M (NVX-CoV2705) in adults 50 to \< 65 years of age who are not considered to be at high risk of severe coronavirus disease 2019 (COVID-19). This study will be conducted in the United States (US). Approximately 6,500 participants will be randomized in a 1:1 ratio via block randomization to receive a single intramuscular (IM) injection of NVX-CoV2705 or placebo (normal saline) on Day 0 and remain on study for efficacy and safety data collection through Day 180/end of study (EoS).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
6,500
NVX-CoV2705 vaccine in a 0.5 mL injection volume at an antigenic dose of 5 µg with 50 µg Matrix-M adjuvant
Placebo (normal saline) in a 0.5 mL injection volume.
First episode of PCR-positive symptomatic COVID 19
First episode of PCR-positive symptomatic COVID 19 from Day 0 (post vaccination) through Day 180/EoS
Time frame: Day 0 to Day 180
First episode of PCR-positive symptomatic COVID 19
First episode of PCR-positive symptomatic COVID 19 through Day 180/EoS
Time frame: Day 42 to Day 180
Participants with Medically attended adverse events (MAAEs), Serious adverse event (SAEs) and Adverse event of special interest (AESIs)
Number of participants reported MAAEs attributable to study vaccine, SAEs, or AESIs through Day 180/EoS.
Time frame: Day 180
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