A Trial to Evaluate the Safety and Immunogenicity of an Investigational Vaccine for the Preventio… (NCT06998004) | Clinical Trial Compass
CompletedPhase 1
A Trial to Evaluate the Safety and Immunogenicity of an Investigational Vaccine for the Prevention of Yellow Fever, and of an Investigational Vaccine for the Prevention of Rabies, in Healthy Adults
Belgium112 participantsStarted 2024-06-16
Plain-language summary
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.
Who can participate
Age range18 Years – 40 Years
SexALL
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Inclusion Criteria:
* Male or female between, and including, 18 and 40 years of age on the day of the Screening Visit
* Healthy individual, as established by the Investigator
* Able to read and understand the informed consent form, and written informed consent obtained from the participant
* Participants who, in the opinion of the Investigator, can and will comply with the requirements of the protocol
Exclusion Criteria:
* Body Mass Index \<18.0 or \>32.0 kg/m2
* Use of any investigational or non-registered product other than the study intervention within 1 month preceding study vaccination, or planned use during the study period
* Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or non-registered product
* Administration / planned administration of any vaccine not foreseen by the study protocol within 1 month preceding study vaccination and up to Day 31
* Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months preceding study vaccination, or planned chronic administration at any time during the study period
* Planned administration of long-acting immune-modifying drugs at any time during the study period
* Administration of immunoglobulins and / or any blood or blood-derived products within 3 months preceding study vaccination, or planned administration during the study period
* Any confirmed or suspected immunosuppressi…
What they're measuring
1
Occurrence of solicited adverse events
Timeframe: During a 14-day follow-up period after vaccination
2
Occurrence of unsolicited adverse events
Timeframe: From Day 1 up to 1 month after vaccination
3
Occurrence of hematological and biochemical laboratory abnormalities
Timeframe: From Day 1 up to 6 months after vaccination
4
Occurrence of adverse events of special interest
Timeframe: From Day 1 up to 1 year after vaccination
5
Occurrence of serious adverse events
Timeframe: From Day 1 up to 1 year after vaccination