Clinical Trial of Freeze-dried Human Rabies Vaccine (Human Diploid Cells)
ConditionRabies
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age10-60
SponsorNingbo Rongan Biological Pharmaceutical Co., Ltd.
About this trial
The Phase 3 clinical trial of freeze-dried human rabies vaccine (human diploid cells) adopted a randomized, blinded, parallel control,non-inferiority design,and administered vaccines to participants aged 10 to 60 years with different immunization schedules (5-dose schedule group, two simple 4-dose schedule groups, and 2-1-1 schedule group) to evaluate the immunogenicity and safety of the vaccine.
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 cells)
- Freeze-dried human rabies vaccine (human diploid cells)
- Freeze-dried human rabies vaccine (human diploid cells)
- Freeze-dried human rabies vaccine (human diploid cells)
- Freeze-dried human rabies vaccine (human diploid cells)
Treatment groups
3,000 Participants
are divided into 5 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov