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:
- 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.
- Participants unvaccinated to SARS-CoV-2 or participants previously vaccinated with a COVID-19 vaccine ≥ 90 days prior to study vaccination.
- Participant or legally acceptable representative is willing and able to give informed consent prior to study enrollment and to comply with study procedures.
- 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.
- Condoms (male or female) with spermicide (if acceptable in country)
- Diaphragm with spermicide
- Cervical cap with spermicide
- Intrauterine device
- Oral or patch contraceptives
- Norplant®, Depo-Provera®, or other in country regulatory approved contraceptive method that is designed to protect against pregnancy
- 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.
- 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.