Prevention of COVID-19 caused by SARS-CoV-2.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
99
Study vaccine was administered as a single intramuscular injection.
Study vaccine was administered as a single intramuscular injection.
Study vaccine was administered as a single intramuscular injection.
Lynn Institute of Denver - ERN
Aurora, Colorado, United States
Number of Participants With Adverse Events of Special Interest (AESIs) From Study Vaccination Through the End of the Study
An AESI (serious or nonserious) is defined as an AE or SAE of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor could be appropriate.
Time frame: From Day 1 up to Day 180 (including Day 180)
Number of Participants With Serious Adverse Events (SAEs) From Study Vaccination Through the End of the Study
An SAE is defined as any event that: • Results in death • Is immediately life-threatening • Requires inpatient hospitalization or prolongation of existing hospitalization • Results in persistent or significant disability/incapacity • Is a congenital anomaly/birth defect • Is a spontaneous miscarriage Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered SAEs when, based upon appropriate medical judgment, they may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization, or the development of drug dependency or drug abuse.
Time frame: From Day 1 up to Day 180 (including Day 180)
Number of Participants With Medically Attended Adverse Events (MAAEs) From Study Vaccination Through the End of the Study
An MAAE is defined as an AE that results in a visit to a medical professional. Medically attended visits are defined as a telemedicine visit, physician's office visit, urgent care visit, emergency room visit, hospitalization, or death.
Time frame: From Day 1 up to Day 180 (including Day 180)
Number of Participants With Solicited Local Adverse Events (AEs) up to 7 Days After Study Vaccination
Assessed solicited local reactions were injection site pain, redness, swelling, and lymphadenopathy.
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Study vaccine was administered as a single intramuscular injection.
Study vaccine was administered as a single intramuscular injection.
Study vaccine was planned to be administered intramuscularly. No vaccine was administered in the CV2CoV (20 µg) Group, since there were no participants enrolled in it.
GSK Investigational Site
Hallandale, Florida, United States
MD Clinical - Velocity
Hallandale, Florida, United States
GSK Investigational Site
Lakeland, Florida, United States
Accel Research Sites
Lakeland, Florida, United States
GSK Investigational Site
Miami, Florida, United States
Suncoast Research Group LLC - ERN-PPDS
Miami, Florida, United States
GSK Investigational Site
Palm Springs, Florida, United States
Affinity Health Corp
Oak Brook, Illinois, United States
GSK Investigational Site
Oak Brook, Illinois, United States
...and 14 more locations
Time frame: From Day 1 to Day 7 (including Day 7)
Number of Participants With Each Solicited Systemic AEs up to 7 Days After Study Vaccination
Assessed solicited systemic reactions were fever, headache, fatigue, myalgia, arthralgia, and chills.
Time frame: From Day 1 to Day 7 (including Day 7)
Number of Participants With Unsolicited AEs up to 28 Days After Study Vaccination, Including Clinically Relevant Abnormal Clinical Safety Laboratory Findings
An unsolicited AE is defined as any AE that is volunteered from the participant and occurs within 28 days after vaccination.
Time frame: From Day 1 to Day 28 (including Day 28)
Geometric Mean Titers (GMTs) of Neutralizing Antibody Titers Against Pseudovirus Bearing Spike Protein From SARS CoV 2 Wild Type (WT)
Time frame: At Day 1, Day 8, Day 15, Day 29, Day 85, and Day 180
Percentage of Participants With Seroresponse (>= 4 Fold Rise From Baseline) at Day 29 After the Booster Dose
Percentage of participants with seroresponse against antigen SARS-CoV-2 WT, Beta, Omicron BA.1, Omicron BA.2, Delta assessed were reported. Seroresponse was defined as greater than equal to (\>=) 4-fold increase from Day 1 (Baseline) to the Day 29. The fold rise was calculated as the ratio of the post-vaccination Neutralizing Antibody Titers to the pre-vaccination Neutralizing Antibody Titers.
Time frame: At Day 29 (29 days post booster dose)
Geometric Mean Increase (GMI) From Baseline of Neutralizing Antibody Titers Against Pseudovirus Bearing Spike Protein From SARS CoV 2 WT at Each Collection Time Point
Time frame: At Day 8, Day 15, Day 29, Day 85, and Day 180
GMTs of Binding Immunoglobulin G (IgG) Against SARS CoV-2 S Protein and Receptor-Binding Domain (RBD)
Time frame: At Day 8, Day 15, Day 29, Day 85 and Day 180
GMI From Baseline of Binding IgG Against SARS CoV-2 S Protein and RBD
Time frame: At Day 8, Day 15, Day 29, Day 85, and Day 180