The purpose of this study is to assess the safety and immunogenicity of vYF in adults aged 18 years and over in Japan. Study details include: * The study duration will be up to approximately 1 month. * One single dose of vYF will be administrated subcutaneously at the 1st visit. * The visit frequency will be Day 01 (Visit 01) and Day 29 (Visit 02). One telephone call (TC) will be planned at Day 15. Number of Participants: A total of 254 participants is expected to be included in the study with the aim to obtain a total of 203 evaluable participants. Study Arms and Duration: Eligible participants will receive, subcutaneously, a single dose of vYF vaccine on Day 1. The duration of each participation will be approximately 1 month for each participant.
Duration of study participation: approximately 1 month for each participant
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
254
Pharmaceutical form:Powder and diluent for suspension for injection-Route of administration:Subcutaneous
Investigational Site Number : 3920001
Takatsuki, Osaka, Japan
Investigational Site Number : 3920002
Chūō, Tokyo, Japan
Investigational Site Number : 3920003
Shinjuku-ku, Tokyo, Japan
Investigational Site Number : 3920004
Taitō City, Tokyo, Japan
Percentage of participants with seroconversion to YF virus in YF-naive participants
Seroconversion rates will be assessed using a YF MN assay Seroconversion is defined as a 4-fold increase in neutralizing Ab (NAb) titers as compared to the pre-vaccination value (Day 01)
Time frame: 28 days after one dose of vYF vaccine
Percentage of participants with seroprotection to YF virus
Seroprotection is defined as NAb titers ≥ 10 (1/dil) at the corresponding timepoint
Time frame: At Day 01 and Day 29
Percentage of participants with seroconversion to YF virus
Seroconversion rates will be assessed using a YF MN assay Seroconversion is defined as a 4-fold increase in neutralizing Ab (NAb) titers as compared to the pre-vaccination value (Day 01)
Time frame: 28 days after one dose of vYF vaccine
Geometric Mean Titers (GMTs) of neutralizing antibodies against YF virus
Antibody titers are expressed as GMTs
Time frame: At Day 01 and Day 29
Geometric Mean Titers Ratio (GMTRs) of neutralizing antibodies against YF virus
GMTRs Day 29/Day 01
Time frame: At Day 01 and Day 29
Number of participants with immediate adverse events
Immediate adverse events are any unsolicited systemic adverse events reported in the 30 minutes after vaccination
Time frame: Within 30 minutes after vaccination
Number of participants with solicited injection site reactions
Solicited injection site reactions: injection site pain, injection site erythema, injection site swelling
Time frame: Within 7 days after vaccination
Number of participants with solicited systemic reactions
Solicited systemic reactions: fever, headache, fatigue, myalgia
Time frame: Within 14 days after vaccination
Number of participants with unsolicited adverse events (AEs), including adverse events of special interest (AESIs)
Unsolicited (spontaneously reported) AEs, not fulfilling criteria for solicited adverse reactions, including AESIs
Time frame: Within 28 days after vaccination
Number of participants with serious adverse events (SAEs) including serious AESIs
SAEs including serious AESIs
Time frame: Within 28 days after vaccination
Number of participants with related SAEs and all deaths
Related SAEs and all deaths
Time frame: From Day 01 to Day 29 after vaccination
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