Health TrialsbyHealthPanel

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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Freeze-dried human rabies vaccine (human diploid cells)

    Biological/Vaccine

    This vaccine is produced by Ningbo Rongyu Biopharmaceutical Co., LTD. Participants will be administered 5 doses of freeze-dried human rabies vaccine (human diploid cells) by intramuscular injection. Receive 1 dose on day 0, 3, 7, 14 and 28, total 5 doses

  • Freeze-dried human rabies vaccine (human diploid cells)

    Biological/Vaccine

    This vaccine is produced by Ningbo Rongyu Biopharmaceutical Co., LTD. Participants will be administered 4 doses of freeze-dried human rabies vaccine (human diploid cells) by intramuscular injection. Receive 1 dose on day 0, 3, 7 and 14, total 4 doses

  • Freeze-dried human rabies vaccine (human diploid cells)

    Biological/Vaccine

    This vaccine is produced by Ningbo Rongyu Biopharmaceutical Co., LTD. Participants will be administered 4 doses of freeze-dried human rabies vaccine (human diploid cells) by intramuscular injection. Receive 1 dose on day 0, 3, 7 and 28, total 4 doses

  • Freeze-dried human rabies vaccine (human diploid cells)

    Biological/Vaccine

    This vaccine is produced by Ningbo Rongyu Biopharmaceutical Co., LTD. Participants will be administered 4 doses of freeze-dried human rabies vaccine (human diploid cells) by intramuscular injection. Receive 2 dose on day 0, 1 dose on day 7 and 21, total 4 doses

  • Freeze-dried human rabies vaccine (human diploid cells)

    Biological/Vaccine

    This vaccine is produced by Chengdu Kanghua Biological Products Co., LTD Participants will be administered 5 doses of freeze-dried human rabies vaccine (human diploid cells) by intramuscular injection Receive 1 dose on day 0, 3, 7, 14and 28, total 5 doses

Treatment groups

3,000 Participants
are divided into 5 treatment groups
Group A: group 1Experimental treatment 1 intervention
Group B: group 2Experimental treatment 1 intervention
Group C: group 3Experimental treatment 1 intervention
Group D: group 4Experimental treatment 1 intervention
Group E: group 5Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Antibody SCR for the 5-dose schedule group of the trial vaccine and the 5-dose schedule group of the control vaccine

Antibody seroconversion rates in the 5-dose schedule group of the trial vaccine and the 5-dose control vaccine group.

Time frame
14 days after the first dose
2

Antibody GMC for the 5-dose schedule group of the trial vaccine and the 5-dose schedule group of the control vaccine

Antibody Geometric Mean Concentration in the 5-dose schedule group of the trial vaccine and the 5-dose control vaccine group.

Time frame
14 days after the first dose
3

Antibody SCR for the simple 4-dose schedule group 1 of the trial vaccine and the 5-dose schedule group of the control vaccine

Antibody seroconversion rates in the simple 4-dose schedule group 1 of the trial vaccine and in the 5-dose group of the control vaccine.

Time frame
14 days after the first dose
4

Antibody GMC for the simple 4-dose schedule group 1 of the trial vaccine and the 5-dose schedule of the control vaccine

Antibody Geometric Mean Concentration in the simple 4-dose schedule group 1 of the trial vaccine and in the 5-dose group of the control vaccine.

Time frame
14 days after the first dose

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ningbo Rongan Biological Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: