Acute febrile illness with temperature higher than or equal to 100.4☏ (38.0☌) or acute onset of upper or lower respiratory tract symptoms (e.g., cough, shortness of breath, sore throat).Be post-menopausal or be surgically sterile or have a partner who is sterile or use medically effective contraception with a failure rate of Phase 2 only: Screening laboratory results within normal limits for testing laboratory or are deemed not clinically significant by the Investigator.Working or residing in an environment with high risk of exposure to SARS-CoV-2 for whom exposure may be relatively prolonged or for whom personal protective equipment (PPE) may be inconsistently used, especially in confined settings.Phase 3: Change From Baseline in Neutralizing Antibody Response Measured by a Pseudovirus-based Neutralization Assay.Phase 3: Change From Baseline in Antigen-specific Cellular Immune Response Measured by IFN-gamma ELISpot Assay.Phase 3: Percentage of Participants, (SARS-CoV-2 seropositive at baseline), With Virologically-Confirmed COVID-19 Disease.Phase 3: Percentage of Participants, (SARS-CoV-2 seronegative at baseline), With Death From COVID-19 Disease.
Phase 2 and 3: Percentage of Participants With Adverse Events of Special Interest (AESIs).Phase 2 and 3: Percentage of Participants With Serious Adverse Events (SAEs).Phase 2 and 3: Percentage of Participants With Solicited and Unsolicited Systemic Adverse Events (AEs).Phase 2 and 3: Percentage of Participants With Solicited and Unsolicited Injection Site Reactions.Mary Johnston Hospital, 2nd Floor Dispensary Building 1221 Juan Nolasco St., Tondo, Manila UERMMMC Research Institute for the Health Sciences Ethics Review Committee UPM-Philippine General Hospital Section of Adult Pulmonary Medicine, Ground floor, Central Block, Taft Avenue, Manila, Philippines 1000 University of the Philippines Manila - Research Ethics Board University of the Philippines - Philippine General Hospital
Jaro, Iloilo City, Philippines 5000 West Visayas State University Unified Biomedical Research Ethics Review Committee West Visayas State University Medical Center, 5th floor, Research Room, E. West Visayas State University Medical Center Las Piñas Doctors Hospital, 7th Floor Medical Arts Building, #8009 CAA Rd, Pulanglupa II, Las Piñas, Metro Manila, Philippines 1742 UERMMMC Research Institute for the Health Sciences Ethics Review Committee Lung Center of the Philippines, Clinical Research Facility Building, Quezon Avenue Extension, Quezon City, Philippines 1100 Lung Center of the Philippines - Institutional Ethics Review Board Aquino Drive, Bacolod City, Negros Occidental, Philippines 6100 West Visayas State University Unified Biomedical Research Ethics Review CommitteeĪsian Hospital and Medical Center, 2205 Civic Drive, Filinvest Corporate City, Alabang, Muntinlupa City, Philippines 1780 Asian Hospital and Medical Center Research Ethics Committee Torre Memorial Medical Hospital Room 503 Medical Arts Bldg., B.S.
0 kommentar(er)
