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
Qualifiers
(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
Treatments tested in this trial
- Freeze-dried Human Rabies Vaccine（Human Diploid Cell）, Essen
- Freeze-dried Human Rabies Vaccine（Human Diploid Cell），Zagreb
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov