The main purpose of this study is to assess the safety and reactogenicity of the Ad26.preF based RSV vaccine administered intramuscularly as a single injection versus placebo in Japanese adults aged greater than equal to 60 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
36
Participants will receive single IM injection of Ad26.preF RSV based vaccine on Day 1.
Participants will receive a single IM injection of matching placebo on Day 1.
Souseikai Hakata Clinic
Fukuoka, Japan
Number of Participants with Solicited Local Adverse Events (AEs) After Vaccination
Number of participants with solicited local AE's will be evaluated. Solicited local AEs (including erythema, swelling, and pain/tenderness at the study vaccine injection site) will be noted in the participant diary after 7 days of vaccination.
Time frame: 7 days after vaccination (Day 1 to Day 8)
Number of Participants with Solicited Systemic Adverse Events (AEs) After Vaccination
Number of participants with solicited systemic AEs will be evaluated. Solicited systemic AEs (fatigue, headache, myalgia, nausea and fever) will be noted in the participant diary after 7 days of vaccination.
Time frame: 7 days after vaccination (Day 1 to Day 8)
Number of Participants with Unsolicited AEs
Number of participants with unsolicited AEs will be evaluated. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Unsolicited AEs will include all AEs for which the participant is not specifically questioned in the participant diary.
Time frame: 28 days after vaccination (Day 1 to Day 29)
Number of Participants with Serious Adverse Events (SAEs)
Number of participants with SAEs will be evaluated. A SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life threatening experience, is a congenital anomaly/birth defect, is suspected transmission of any infectious agent via a medicinal product, is medically important, and may jeopardize participant or may require medical or surgical intervention to prevent one of the outcomes listed above.
Time frame: First vaccination (Day 1) to the end of the study (up to Day 183)
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RSV Neutralization Assay
Analysis of neutralizing antibodies to RSV A strain will be performed.
Time frame: Day 1 (pre-vaccination), Days 14, 28, and 182 (post-vaccination)
RSV Fusion Protein (F-Protein) Binding Antibodies by Enzyme-linked Immunosorbent Assay (ELISA)
Antibodies binding to RSV F-protein in pre-fusion and post-fusion forms will be assessed by ELISA.
Time frame: Day 1 (pre-vaccination), Days 14, 28, and 182 (post-vaccination)
Interferon (IFN)-Gamma Enzyme-Linked Immunospot (ELISpot) Assay
RSV F-specific cellular immune responses elicited by the different vaccine regimens.
Time frame: Day 1 (pre-vaccination) and Day 29 (post-vaccination)