The purpose of this study is to demonstrate non-inferiority in terms of humoral immune responses of Ad26.RSV.preF-based study vaccine lots representative of different aged vaccine in comparison to a non-aged Ad26.RSV.preF-based study vaccine lot.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
755
Ad26.RSV.PreF-based Vaccine will be administered as single IM injection.
North Alabama Research Center, LLC
Athens, Alabama, United States
Achieve Clinical Research, LLC
Vestavia Hills, Alabama, United States
Hope Research Institute
Phoenix, Arizona, United States
Geometric Mean Titers (GMTs) of Prefusion F-protein (preF) Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) 14 Days Post Vaccination
GMTs of pre-F antibodies as assessed by ELISA at 14 days post administration of Ad26/protein preF RSV vaccine were reported.
Time frame: 14 days post vaccination on Day 1 (Day 15)
Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days Post Vaccination
RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay at 14 days post administration of Ad26/protein preF RSV-based vaccine were expressed as 50 percent (%) inhibitory concentration (IC50) units.
Time frame: 14 days post vaccination on Day 1 (Day 15)
Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days Post Vaccination
Number of participants with solicited local AEs 7 days post vaccination were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site).
Time frame: Up to Day 7 post vaccination on Day 1 (up to Day 8)
Number of Participants With Solicited Systemic AEs for 7 Days Post Vaccination
Number of participants with solicited systemic AEs 7 days post vaccination were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited systemic events include events such as fatigue, headache, nausea, myalgia, and pyrexia, for which participants were specifically questioned and which were noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
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Clinical Research Consulting
Milford, Connecticut, United States
Accel Research Sites
DeLand, Florida, United States
Pharmax Research Clinic Inc
Miami, Florida, United States
Suncoast Research Group
Miami, Florida, United States
Suncoast Research Associates, LLC
Miami, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Centennial Medical Group
Elkridge, Maryland, United States
...and 3 more locations
Time frame: Up to Day 7 post vaccination on Day 1 (up to Day 8)
Number of Participants With Unsolicited AEs for 28 Days Post Vaccination
Number of participants with unsolicited AEs 28 days post vaccination were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant was not specifically questioned in the participant diary.
Time frame: Up to 28 days post vaccination on Day 1 (up to Day 29)
Number of Participants With Serious Adverse Events (SAEs) Until 6 Months Post Vaccination
Number of participants with SAEs until 6 months post vaccination were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is any untoward medical occurrence that at any dose may result in death, is 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 suspected transmission of any infectious agent via a medicinal product.
Time frame: From Day 1 up to 6 months post vaccination on Day 1 (up to Day 183)
Number of Participants With Adverse Event of Special Interests (AESIs) Until 6 Months Post Vaccination
Number of participants with AESIs until 6 months post vaccination were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Thrombosis with thrombocytopenia syndrome (TTS) was considered as an AESI.
Time frame: From Day 1 up to 6 months post vaccination on Day 1 (up to Day 183)