A Clinical Trial of Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried
ConditionRabies
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age10-60
SponsorNingbo Rongan Biological Pharmaceutical Co., Ltd.
About this trial
The Phase 1 clinical trial of the freeze-dried human rabies vaccine (human diploid cells) will be conducted on participants aged 10 to 60. This study will design a single-arm, randomized, open-access trial with different immunization schedules (5-dose schedule and 2-1-1 schedule) to evaluate the safety and tolerability of the vaccine in participants aged 10 to 60
Eligibility criteria
This trial accepts healthy volunteersQualifiers
(1) The participants' ages range from 10 to 60 years old (≥10 years old and <61 years old).
Disqualifiers
For the standards marked with *, if the participants have the circumstances stipulated in the standard, the visit can be rescheduled when they no longer have these circumstances
After inquiry, it is found that there is a history of rabies vaccination or the use of passive immunization preparations for rabies virus.
There was a history of injury from rabies virus-susceptible animals (such as cats and dogs) before the first dose of vaccination;
The axillary body temperature of the participants on the day of enrollment was ≥37.3℃*;
Trial design
Design model
Parallel
Treatments tested in this trial
Freeze-dried Human Rabies Vaccine（Human Diploid Cell）, Essen
Biological/VaccineThis vaccine is produced by Ningbo Rongyu Biological Pharmaceutical Co., Ltd.. Participants will receive AIM2301 by intramuscular injection. Receive on the day 0, 3, 7, 14 and 28, a total of 5 doses
Freeze-dried Human Rabies Vaccine（Human Diploid Cell），Zagreb
Biological/VaccineThis vaccine is produced by Ningbo Rongyu Biological Pharmaceutical Co., Ltd.. Participants will receive AIM2301 by intramuscular injection. Receive 2 doses on day 0, 1 dose on day 7 and day 21, a total of 4 doses.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Group1Experimental treatment 1 intervention
Group B: Group2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The occurrence of AE and AR within 30 minutes after each dose of vaccination
After each dose of the investigational vaccine is administered, participants should be observed on-site for 30 minutes. The contents of safety observation include any medical events occurring in participants. The severity and relevance of AEs shall be determined in accordance with the guidance for adverse event grading criteria and the guidance for relevance determination.
Time frame
within 30 minutes after each dose of vaccination2
The occurrence of AE and AR within 7 days after each dose of vaccination
After each dose of vaccine is administered, a Diary Card will be issued to participants. Participants and/or their guardians should measure body temperature daily from Day 0 to Day 7 and observe/record all adverse events (AEs) as well as concomitant medications/vaccines according to the requirements of the Diary Card. The severity and relevance of AEs shall be determined in accordance with the guidance for adverse event grading criteria and the guidance for relevance determination.
Time frame
within 7 days after each dose of vaccination3
The occurrence of AE and AR within 30 days from the first dose of vaccination to the full course of vaccination
Solicited and unsolicited adverse events from the first dose vaccination to 30 days after full-course vaccination shall be collected through diary cards and contact cards. The severity and relevance of AEs shall be determined in accordance with the guidance for adverse event grading criteria and the guidance for relevance determination.
Time frame
within 30 days from the first dose of vaccination to the full course of vaccination4
Abnormal changes /Occurrence of clinically significant abnormal changes in laboratory test indicators
Abnormal changes /Occurrence of clinically significant abnormal changes in laboratory test indicators (blood biochemistry, blood routine and urine routine) on the third day after the first dose of vaccination
Time frame
the third day after the first dose of vaccinationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov