Prevention of COVID-19 caused by SARS-CoV-2.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
185
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.
GSK Investigational Site
Sacramento, California, United States
GSK Investigational Site
Hollywood, Florida, United States
Number of Participants With Solicited Local Adverse Events (AE) During 7 Days After Vaccination
Assessed solicited local adverse events were injection site pain, redness, swelling, and Lymphadenopathy.
Time frame: From Day 1 to Day 7 (including Day 7)
Number of Participants With Solicited Systemic AE During 7 Days After Vaccination
Assessed solicited systemic AEs 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 for 28 Days After Study Vaccination
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)
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 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 serious adverse event (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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Study vaccine was administered as a single intramuscular injection.
GSK Investigational Site
Melbourne, Florida, United States
GSK Investigational Site
Savannah, Georgia, United States
GSK Investigational Site
Peoria, Illinois, United States
GSK Investigational Site
Metairie, Louisiana, United States
GSK Investigational Site
Rockville, Maryland, United States
GSK Investigational Site
Omaha, Nebraska, United States
GSK Investigational Site
Binghamton, New York, United States
GSK Investigational Site
Cincinnati, Ohio, United States
...and 7 more locations
Time frame: From Day 1 up to Day 180 (including Day 180)
Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination
An abnormal laboratory is defined as any value outside of the normal range. Normal ranges were: Alanine Aminotransferase: (Female: 10-32 micro (u)/ liter (L); Male: 10-40 u/L); Alkaline Phosphatase: (Female: 30-115 u/L; Male: 43-115 u/L); Aspartate Aminotransferase: (Female: 10-36 u/L; Male: 10-43 u/L); Bilirubin total: 0.1-1.1 milligram (mg)/deciliter (dL); Bilirubin, Direct: 0-0.4 mg/dL ;Creatinine:0.7-1.4 mg/dL; Eosinophils: 0%-7%; Eosinophils/Leukocytes: 0.00-0.80 x 10\^3/uL ; Erythrocytes: (Female: 3.70-5.20 x 10\^6/uL; Male: 4.63-6.08x 10\^6/uL); Hemoglobin: (Female: 11.0-15.5 gram (g)/dL; Male: 12.5-17.0 g/dL); Leukocytes: 3.70-11.00 x 10\^3/uL; Lymphocytes 12.0%-46.0%; Lymphocytes/Leukocytes: 0.90-3.60 x 10\^3/uL; Monocytes/Leukocytes: 0.00-1.20 x 10\^3/uL; Neutrophils: 4.0% - 71.0%; Neutrophils/Leukocytes:1.70-7.90x 10\^3/uL; Platelets: 163-375 x 10\^3/uL; Urea Nitrogen: 5-20 mg/dL.
Time frame: 8 days from vaccination at Day 1
Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint
Time frame: At Day 1, Day 15, Day 29, Day 91, and Day 181
Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point
Time frame: At Day 15, Day 29, Day 91, and Day 181
Percentage of Participants With Neutralizing Seroresponse of Serum SARS-CoV-2 WT, Omicron BA.1, BA.2 and BA.5 Variants Specific Ab at Day 29
Seroresponse was defined as post-boost titers \>= 4 times pre-boost (baseline) titers for participants with titer \>= LLOQ at pre-vaccination and as post-booster titer \>= 4 times LLOQ for participants with titer \< LLOQ at pre vaccination.
Time frame: At day 29 (28 days after the booster dose)