Coronavirus – PR01298 Novavax 2019nCoV-420

Participating in a clinical trial with Profound means making a real difference in the lives of others facing similar health challenges.

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.

Inclusion Criteria:

  • To be included in this study, each individual must satisfy all of the following criteria:
    1. Adults 50 to < 65 years of age at time of study vaccination (Day 0) who are not considered to be at high risk of severe COVID-19.
    2. Participants unvaccinated to SARS-CoV-2 or participants previously vaccinated with a COVID-19 vaccine ≥ 90 days prior to study vaccination.
    3. Participant or legally acceptable representative is willing and able to give informed consent prior to study enrollment and to comply with study procedures.
    4. Female participants of childbearing potential (defined as any participant who has experienced menarche and who is NOT surgically sterile [ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea ≥ 12 consecutive months]) must agree to be heterosexually inactive from at least 28 days prior to enrollment and through 90 days after vaccination OR agree to consistently use a medically acceptable method of contraception listed below from ≥ 28 days prior to enrollment and through 90 days after vaccination.
      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 NOTE: Periodic abstinence (eg, calendar, ovulation, sympto-thermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
    5. Agrees not to participate in any research involving receipt of investigational products (drug/biologic/device), including other SARS-CoV-2 prevention or treatment trials, for the duration of the study.
  • Other criteria may apply

Complete the form and our team will reach out soon to help determine your eligibility.

View Study on ClinicalTrials.gov

Trial Interest Form

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