A Study to Evaluate the Efficacy, Safety, and Immunogenicity of SARS-CoV-2 Variant (BA.4 /5) mRNA… (NCT05636319) | Clinical Trial Compass
UnknownPhase 2/3
A Study to Evaluate the Efficacy, Safety, and Immunogenicity of SARS-CoV-2 Variant (BA.4 /5) mRNA Vaccine
Indonesia14,168 participantsStarted 2022-11-23
Plain-language summary
A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Efficacy, Safety, and Immunogenicity of SARS-CoV-2 Variant (BA.4 /5) mRNA Vaccine (ABO1020) in Healthy Subjects Aged 18 Years and Older Who Have Completed the Full Vaccination
Who can participate
Age range18 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
✓. Voluntarily sign the ICF approved by the Ethics Committee before any study procedure and agree to participate in the study.
✓. Healthy male or female able to provide legal identity certificate and aged 18 years and older when signing the ICF.
✓. Subjects who have previously been fully vaccinated either by 2 or 3 doses of SARS-CoV-2 inactivated vaccine. The last dose of immunization should be \>6 months before administration of the investigational products.
✓. Be able to communicate well with the investigator, and to understand and comply with the requirements of this clinical trial.
✓. Males and females with childbearing potential voluntarily take effective contraceptive methods from signing ICF to 3 months after completing the vaccination, including sexual abstinence or effective contraceptive measures (e.g., intrauterine or implanted contraceptive device, oral contraceptives, injected or implanted contraceptives, sustained-release topical contraceptives, intrauterine device \[IUD\], condoms \[male\], diaphragm, and cervical cap).
Exclusion criteria
✕. Positive SARS-CoV-2 rapid test at screening.
✕. Prior medical history of severe acute respiratory syndrome (SARS), middle east respiratory syndrome (MERS).
✕. Fever (axillary temperature or equivalent ≥ 37.3℃\*) on the day of vaccination with this investigational vaccine or within recent 72 hours.
✕. Abnormal vital signs (pulse \< 60 bpm or \> 100 bpm, systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg when keeping awake) with clinical relevance.
What they're measuring
1
In Phase 1/2, Incidence of solicited adverse events
Timeframe: 0 to 14 days after each dose
2
In Phase 1/2, Incidence of unsolicited adverse events
✕. Do not remain overall healthy (i.e., has medically deteriorated significantly since receiving the two-dose vaccination, is anticipated to have fatal outcome of uncontrolled diseases within 12 months, and is not able to provide blood as specified by the trial with anticipated, deleterious medical consequences) in the clinical judgment of the investigator based on medical history and physical examination.
✕. Pregnant or lactating women, or those who plan to donate sperm or egg during the trial.
✕. Prior history of allergic reaction or anaphylaxis to any vaccine or its excipients, e.g., hypersensitivity, urticaria, serious eczema, dyspnea, laryngeal edema, and angioedema etc.
✕. Prior use of any other vaccine within 28 days before using the investigational products or planning to use any vaccine other than the investigational products during the study period.