A Phase I Clinical Trial to Evaluate the Safety of Different Immunization Schedules of a Lyophili… (NCT07338786) | Clinical Trial Compass
By InvitationPhase 1
A Phase I Clinical Trial to Evaluate the Safety of Different Immunization Schedules of a Lyophilized Human Rabies Vaccine (Human Diploid Cell)
China80 participantsStarted 2025-09-13
Plain-language summary
This clinical trial employed a single-center, open-label, single-arm design. A total of 80 participants aged 10 to 60 years were enrolled and divided into two age groups: 40 in the 18-60 years cohort and 40 in the 10-17 years cohort. All participants received the lyophilized human rabies vaccine (human diploid cell)
Who can participate
Age range10 Years – 60 Years
SexALL
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Inclusion Criteria:
* Participants aged 10 to 60 years;
* Informed consent can be obtained from the participant and/or their guardian;
* The participant and/or guardian are able to comply with the requirements of the clinical trial protocol.
Exclusion Criteria:
* Axillary temperature\>37.0°C on the day of vaccination
* History of rabies vaccination or use of rabies virus passive immunization preparations
* History of dog or other mammalian bites or scratches (with skin laceration) within 1 year prior to the first vaccination
* Abnormalities in laboratory tests such as complete blood count (CBC), blood biochemistry, and urinalysis before the first vaccination are clinically significant and cannot be excluded based on the investigator's comprehensive assessment.
* Suffering from acute illness or acute exacerbation of chronic disease within 3 days prior to the first vaccination
* Urinary pregnancy test results were positive in female participants of childbearing age, or they were in the lactation period, or female participants of childbearing age, male participants, or their partners had fertility plans during the trial period.
* History of severe allergic reactions requiring medical intervention or severe adverse reactions to vaccines (e.g., severe urticaria, anaphylactic shock, allergic laryngeal edema, Henoch-Schönlein purpura, localized allergic necrotic reaction (Arthus reaction), angioedema, etc.), or allergy to any component of the trial vaccine, such as human serum al…