Safety and Reactogenicity Trial of Vaccine for the Prevention of Infections Caused by Haemophilus… (NCT05401305) | Clinical Trial Compass
CompletedPhase 1
Safety and Reactogenicity Trial of Vaccine for the Prevention of Infections Caused by Haemophilus Influenzae Type b
Russia60 participantsStarted 2020-01-14
Plain-language summary
Trial purpose is to evaluate the safety, tolerability and reactogenicity of the Vaccine for the prevention of infections caused by Haemophilus Influenzae Type b in volunteers aged 18-50.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion Criteria:
* Healthy volunteers (men and women) aged 18-50 years;
* Written informed consent of volunteers to participate in the clinical trial;
* Volunteers not previously vaccinated with any vaccine to prevent infections caused by Haemophilus influenza type b;
* Volunteers able to fulfill requirements of the Protocol (i.e. fill out the patient's diary, come to follow-up visits);
* For fertile women, a negative pregnancy test and consent to observe adequate methods of contraception (if hormonal contraceptives are used, they must be canceled at least 2 months before the start of the trial). All women with childbearing potential must have a negative pregnancy test result during the Data Collection Period. In the course of the trial women should use contraception methods with a reliability exceeding 90 %, or be sterile, or be in a postmenopausal state. Contraception methods with a reliability exceeding 90 % of common use include cervical caps with spermicide, diaphragms with spermicide, condoms, intra-uterine spirals.
* For the men, are able to conceive - consent to use adequate contraception methods. In the course of the trial, men and their sexual partners should use contraception methods with a reliability exceeding 90 %, or be sterile. Contraception methods with a reliability exceeding 90 % of common use include cervical caps with spermicide, diaphragms with spermicide, condoms, intra-uterine spirals.
Exclusion Criteria:
* A serious post-vaccination reaction (te…
What they're measuring
1
Incidence of local adverse events (AEs)
Timeframe: Days 1-7 post-vaccination
2
Incidence of systemic adverse events (AEs)
Timeframe: Days 1-7 post-vaccination
Trial details
NCT IDNCT05401305
SponsorSt. Petersburg Research Institute of Vaccines and Sera