Trial of the Immunogenicity, Safety, and Tolerability of rF1V Vaccine With CpG 1018® Adjuvant Com… (NCT05506969) | Clinical Trial Compass
CompletedPhase 2
Trial of the Immunogenicity, Safety, and Tolerability of rF1V Vaccine With CpG 1018® Adjuvant Compared With rF1V Vaccine in Adults 18 to 55 Years of Age
United States200 participantsStarted 2022-08-09
Plain-language summary
Phase 2, Randomized, Active-Controlled, Observer-Blinded, Multicenter Trial of the Immunogenicity, Safety, and Tolerability of rF1V Vaccine with CpG 1018® Adjuvant Compared with rF1V Vaccine in Adults 18 to 55 Years of Age
Who can participate
Age range18 Years – 55 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults aged 18 to 55 years
* Healthy participants or participants with pre-existing medical conditions who are in a stable medical condition.
Pre-existing stable medical condition means a subject who: has full capacity of daily activity and no major medication modification within 3 months prior to Day 1; has not undergone surgical or minimally-invasive intervention or had any hospitalization/emergency room visit for the specific medical condition.
* Able to comply with the protocol schedule and procedures.
* Able and willing to provide written informed consent
* If female of child-bearing potential and heterosexually active, has practiced adequate contraception for 28 days prior to vaccination and has negative pregnancy tests just prior to vaccination and has agreed to continue adequate contraception until 28 days after last study injection. Adequate contraception is defined as a contraceptive method with a failure rate of \< 1% per year when used consistently and correctly and, when applicable, in accordance with the product label. Examples include the following:
* Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, or transdermal
* Progestin-only hormonal contraception associated with inhibition of ovulation: oral, injectable, or implantable
* Intrauterine device (IUD) with or without hormonal release
* Vasectomized partner, provided he is the subject's sole part…