A Phase 3, Randomized, Observer-Blinded, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) with Matrix-M1™ Adjuvant in Adult Participants = 18 Years with a Pediatric Expansion in Adolescents (12 to < 18 Years) (Novavax)

Purpose

To evaluate the efficacy of a 2-dose regimen of SARS-CoV-2 rS adjuvanted with Matrix-M1 compared to placebo against polymerase chain reaction (PCR)-confirmed symptomatic coronavirus disease 2019 (COVID-19) illness diagnosed ≥ 7 days after completion of the second injection in the initial set of vaccinations of adult participants ≥ 18 years of age.

Criteria

1. Must be 18 years or older

2. Must be medically stable

3. Must not participate in any other prevention trial during study follow-up.

4. Participants of childbearing potential (defined as any participant who has experienced menarche and who is NOT surgically sterile). Must agree to be heterosexually inactive from at least 28 days prior to enrollment and through 3 months after the last vaccination OR agree to consistently use a medically acceptable method of contraception from at least 28 days prior to enrollment and through 3 months after last vaccination.

You Cannot:

1. Have an unstable acute or chronic medical condition.

2. Have history of previous laboratory-confirmed diagnosis of SARS-CoV-2 infection.

3. Have received any vaccine within 4 days prior to first study vaccination or planned receipt of any vaccine before day 49, except for influenza vaccine.

4. Have any autoimmune or immunodeficiency.

5. Have received any immunoglobulin or blood product withing 90 days prior to first vaccination.

6. Be breastfeeding, pregnant or plan to become pregnant within 3 months following last vaccination.

Details

1. Vaccination for SARS-CoV-2

2. 7 lab draws during two-year study evaluation to be drawn during office visit with doctor conducting the study.

3. Study Stipend

Enrollment Closed

Interested in more information on clinical research? Contact WK Health System Clinical Research Department 318-212-8130 or ckay@wkhs.com

Interested in more information? Contact Us:

Clint Wilson, M.D., Principal Investigator
(318) 212-8130

IRB: CGIRB
IRB Number:
Trial Type: Drug
Sponsor: Novavax