The purpose of this first time in humans trial is to evaluate the safety, reactogenicity and immunogenicity of AVX70120 and of AVX70481 in healthy participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
144
Low dose level of AVX70120, AstriVax' investigational vaccine for the prevention of yellow fever
Middle dose level of AVX70120, AstriVax' investigational vaccine for the prevention of yellow fever
High dose level of AVX70120, AstriVax' investigational vaccine for the prevention of yellow fever
Centre for the Evaluation of Vaccination (CEV)
Antwerp, Belgium
RECRUITINGUniversity Hospital Ghent - Centrum voor Vaccinologie (CEVAC)
Ghent, Belgium
RECRUITINGOccurrence of solicited adverse events
Time frame: During a 14-day follow-up period after vaccination
Occurrence of unsolicited adverse events
Time frame: From Day 1 up to 1 month after vaccination
Occurrence of hematological and biochemical laboratory abnormalities
Time frame: From Day 1 up to 6 months after vaccination
Occurrence of adverse events of special interest
Time frame: From Day 1 up to 1 year after vaccination
Occurrence of serious adverse events
Time frame: From Day 1 up to 1 year after vaccination
Humoral immune response following administration of the investigational vaccines
Time frame: From Day 1 up to 1 year after vaccination
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Low dose level of AVX70481, AstriVax' investigational vaccine for the prevention of rabies
Middle dose level of AVX70481, AstriVax' investigational vaccine for the prevention of rabies
High dose level of AVX70481, AstriVax' investigational vaccine for the prevention of rabies
Placebo