COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05249816

Nawal Al Kaabi

Not reported

2022-02-22

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

inclusion criteria: adults ≥ 18 years of age, inclusive, at screening. willing and able to give informed consent prior to study enrollment and to comply with study procedures. females of childbearing potential (defined as any female who has experienced menarche) who is not surgically sterile (i.e., hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or postmenopausal (defined as amenorrhea at least 12 consecutive months), must agree to either be heterosexually inactive or consistently use a medically acceptable method of contraception, from enrollment and to 3 months after the last vaccination. medically acceptable methods of contraception include: condoms (male or female) 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 (e.g., calendar, ovulation, symptom-thermal, post- ovulation methods) and withdrawal are not acceptable methods of contraception. condoms (male or female) are not required if a female partner is using an alternative medically acceptable method of contraception as listed in points 3a-g). is medically stable, as determined by the investigator (based on review of health status, vital signs [to include body temperature], medical history, and targeted physical examination [to include body weight]). vital signs must be within medically acceptable ranges as determined by the investigator prior to the first vaccination. agrees to not participate in any other sars-cov-2 prevention or treatment trials for the duration of the study. note: for participants who become hospitalized with covid-19, participation in investigational treatment studies is permitted. has previously received a documented complete two dose series of the bbibp-corv vaccine with the second dose having been given at least 180 days prior to study vaccination or has previously received a documented complete two dose series of the bbibp-corv vaccine and a third dose booster of bbibp-corv vaccine, with the third dose having been given at least 90 days prior to study vaccination.

participation in research involving receipt of investigational products (drug/biologic/device) within 90 days prior to first study vaccination. has previously received a primary series vaccination or booster dose of any covid- 19 vaccine other than bbibp-corv. received influenza vaccination within 14 days prior to first study vaccination, or any other vaccine (including covid-19) within 30 days prior to first study vaccination. any known allergies to products contained in the investigational product any history of anaphylaxis to any prior vaccine. autoimmune or immunodeficiency disease/condition (iatrogenic or congenital) requiring ongoing immunomodulatory therapy. note: stable endocrine disorders (eg, thyroiditis, pancreatitis), including stable diabetes mellitus with no history of diabetic ketoacidosis are not excluded. chronic administration (defined as > 14 continuous days) of immunosuppressant, systemic glucocorticoids, or other immune-modifying drugs within 90 days prior to first study vaccination. note: an immunosuppressant dose of glucocorticoid is defined as a systemic dose ≥ 10 mg of prednisone per day or equivalent. the use of topical or intranasal glucocorticoids is permitted. topical tacrolimus and ocular cyclosporin are permitted. use of inhaled glucocorticoids is prohibited. received immunoglobulin, blood-derived products, or immunosuppressant drugs within 90 days prior to first study vaccination. active cancer (malignancy) on therapy within 3 years prior to first study vaccination (with the exception of adequately treated non-melanomatous skin carcinoma or lentigo maligna and uterine cervical carcinoma in situ without evidence of disease, at the discretion of the investigator). participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the end of study. suspected or known history of alcohol abuse or drug addiction within 2 years prior to the first study vaccine dose that, in the opinion of the investigator, might interfere with protocol compliance. any other condition that, in the opinion of the investigator, would pose a health risk to the participant if enrolled or could interfere with evaluation of the study vaccine or interpretation of study results (including neurologic or psychiatric conditions likely to impair the quality of safety reporting). study team member or immediate family member of any study team member (inclusive of sponsor, cro, and study site personnel involved in the conduct or planning of the study)

2

Cogna Technology Solutions LLC

18

100

United Arab Emirates

Healthy volunteers

N/A

1000

Utilizing Case Report Forms and safety follow up via telephone to measure and assess incidence, duration, and severity of solicited local and systemic adverse events (AEs);Utilizing Case Report Forms to measure and assess Incidence, duration, severity, and relationship of unsolicited AEs;Utilizing Case Report Forms to measure incidence and relationship of medically attended adverse events (MAAEs), adverse events of special interest (AESIs) (predefined list), and serious adverse events (SAEs) throughout the study.;Utilizing ratio of IgG GMTs and difference in seroconversion rates to compare IgG antibody responses between the vaccines.

None

Phase 3

[{"arm_notes": "", "treatment_id": 918, "treatment_name": "Nvx-cov2373", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 184, "treatment_name": "Bbibp-corv", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}]