The primary objectives of the study are: * To describe the safety profile of each of the 3 dosages of vYF and of YF-VAX® within the 28 days post-vaccination and up to the 6 months (Day 180) post-vaccination visit * To describe the antibody responses elicited by each of the 3 dosages of vYF and by YF-VAX on Day 0 pre-vaccination and then on Day 10, Day 14, Day 28 and 6 months (Day 180) post-vaccination overall and by baseline flavivirus serostatus * To quantify the detectable yellow fever (YF) vaccinal viremia in each vaccine groups (vYF and YF-VAX) in a subset of subjects on Day 0 visit, Day 1 visit, Day 3 visit, Day 5 visit, Day 7 visit, Day 10 visit, and Day 14 visit.
Study duration per participant is approximately 6 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
73
Pharmaceutical form: Powder and diluent for suspension for injection Route of administration: Subcutaneous
Pharmaceutical form: Powder and diluent for suspension for injection Route of administration: Subcutaneous
Pharmaceutical form: Powder and diluent for suspension for injection Route of administration: Subcutaneous
Pharmaceutical form: Powder and diluent for suspension for injection Route of administration: Subcutaneous
Investigational Site Number 8400001
Silver Spring, Maryland, United States
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 include injection site pain, erythema and swelling
Time frame: Within 7 days after vaccination
Number of participants with solicited systemic reactions
Solicited systemic reactions include fever, headache, malaise, and myalgia
Time frame: Within 14 days after vaccination
Number of participants with unsolicited adverse events
Unsolicited (spontaneously reported) adverse events not fulfilling criteria for solicited adverse reactions
Time frame: Within 28 days after vaccination
Number of participants with Grade 3 fever
Grade 3 fever is defined as temperature ≥ 102.1°F
Time frame: Within 28 days after vaccination
Number of participants with serious adverse events
Serious adverse events are collected throughout the study
Time frame: From Day 0 to Day 180
Number of participants with hematology and biochemistry out-of-range test results
Hematology and biochemistry values that are out-of-range are assessed
Time frame: From Day 0 to Day 14
Number of participants with YF and flavivirus viremia and out-of-normal-range biological test results in the event of severe fever, or suspicion of neurotropic disease or acute viscerotropic diseases
Investigators are provided with guidelines for recognition and assessment of potential viscerotropic and neurotropic events
Time frame: Within 28 days after vaccination
Number of participants with seroconversion to YF virus
Seroconversion is defined as a fourfold increase in neutralizing antibody titers as compared to pre-vaccination value. Seroconversion is assessed from Day 0 (pre-vaccination) to Day 10, Day 14 and Day 28.
Time frame: From Day 0 to Day 28
Number of participants with neutralizing antibody titers against YF virus above pre-defined threshold
Pre-defined threshold of 10 1/dilution
Time frame: From Day 0 to Day 180
Geometric mean titers of neutralizing antibodies against YF virus
Geometric mean titer ratio Day 10/Day 0, Day 14/Day 0, Day 28/Day 0 and Day 180/Day 0
Time frame: From Day 0 to Day 180
Number of participants with YF vaccinal viremia
Vaccinal viremia is measured by YF specific quantitative reverse transcription polymerase chain reaction (RT-PCR) assay in samples collected on Day 0, Day 1, Day 3, Day 5, Day 7, Day 10, and Day 14.
Time frame: From Day 0 to Day 14
Level of YF vaccinal viremia
Vaccinal viremia is measured by YF specific quantitative RT-PCR assay in samples collected on Day 0, Day 1, Day 3, Day 5, Day 7, Day 10, and Day 14.
Time frame: From Day 0 to Day 14
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