Yellow fever vaccine (live)
BiologicalPharmaceutical form:Powder and diluent for suspension for injection-Route of administration:Subcutaneous
Other names: vYF vaccine
NCT Number: NCT07222059
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Investigational Site Number : 3920001, Takatsuki, Osaka, Japan
Duration of study participation: approximately 1 month for each participant
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
OR
. Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 4 weeks after study intervention administration.
A female participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) before any dose of study intervention on Day 01 and will be repeated on Day 29 to confirm the participant is still not pregnant within the 28 days of vaccine administration.
Participants are excluded from the study if any of the following criteria apply:
Pharmaceutical form:Powder and diluent for suspension for injection-Route of administration:Subcutaneous
Other names: vYF vaccine
Time frame: 28 days after one dose of vYF vaccine
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: At Day 01 and Day 29
Seroprotection is defined as NAb titers ≥ 10 (1/dil) at the corresponding timepoint
Time frame: 28 days after one dose of vYF vaccine
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: At Day 01 and Day 29
Antibody titers are expressed as GMTs
Time frame: At Day 01 and Day 29
GMTRs Day 29/Day 01
Time frame: Within 30 minutes after vaccination
Immediate adverse events are any unsolicited systemic adverse events reported in the 30 minutes after vaccination
Time frame: Within 7 days after vaccination
Solicited injection site reactions: injection site pain, injection site erythema, injection site swelling
Time frame: Within 14 days after vaccination
Solicited systemic reactions: fever, headache, fatigue, myalgia
Time frame: Within 28 days after vaccination
Unsolicited (spontaneously reported) AEs, not fulfilling criteria for solicited adverse reactions, including AESIs
Time frame: Within 28 days after vaccination
SAEs including serious AESIs
Time frame: From Day 01 to Day 29 after vaccination
Related SAEs and all deaths
Sanofi Pasteur, a Sanofi Company
Industry
A Phase 3, Single Arm, Open Study to Assess the Immunogenicity and Safety of vYF in Adults Aged 18 Years and Over
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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