A Phase 3 interventional study of Freeze-dried human rabies vaccine (human diploid cells) and Freeze-dried human rabies vaccine (human diploid cells) in Rabies, sponsored by Ningbo Rongan Biological Pharmaceutical Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 10 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-19.
Sponsored by Ningbo Rongan Biological Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Prevention
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.
The trial will use a randomized, blinded, parallel-group, non-inferiority design. A total of 3000 participants will be planned to be randomly assigned in a 1:1:1:1:1 ratio to the 5-dose control vaccine schedule, the 5-dose experimental vaccine schedule, the simple 4-dose experimental vaccine schedule 1, the simple 4-dose experimental vaccine schedule 2, and the 2-1-1 trial vaccine schedule, with 600 participants in each group, including 100 participants aged 10 to 17 years and 500 participants who will be 18-60 years old. Immunogenicity visits will be scheduled for all participants: (1) 5-dose schedule group: before dose 1, day 7 (before dose 3), day 14 (7 after dose 3, before dose 4), day 28 (14 after dose 4, before dose 5), day 42 (14 days after the full schedule); (2) Simple four-dose schedule group 1: before dose 1, day 14 (7 days after dose 3 and before dose 4), day 28 (14 days after the full dose), and day 42 (28 days after the full schedule); (3) Simple four-dose schedule group 2: before dose 1, day 14 (7 days after the third dose), day 28 (before the fourth dose), and day 42 (14 days after the full schedule); (4) 2-1-1 schedule group: before dose 1, day 7 (before the third dose), day 14 (7 days after the third dose) and day 35 (14 days after the full schedule). If the vaccination is delayed, the blood collection time will be postponed according to the vaccination time of the corresponding dose.
A total of 1200 participants in the immune persistence subgroup (including 200 participants aged 10-17 years and 1000 participants aged 18-60 years) will be selected. Blood samples will be collected at 3 months and 6 months after the full schedule of vaccination to evaluate the immune persistence. The first 40% of participants in the 10 to 17 years of age group and the 18 to 60 years of age group enrolled at each site will be selected as participants in the immune persistence subgroup.
All participants will be observed for safety events that will occur from the first dose through 30 days after the full schedule and for SAEs and pregnancy events that will be reported from the first dose through 6 months after the full schedule.
114 studies on the registry are indexed under Rabies; 15 are open to participants now.
This study's planned enrollment of 3,000 is above the median of 201 across 104 interventional studies indexed under Rabies.
Browse Rabies studies →Ningbo Rongan Biological Pharmaceutical Co., Ltd. is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
(1) The participants' ages range from 10 to 60 years old (≥10 years old and \<61 years old).
(2) Participants aged 10 to 17 and their guardians can provide valid identification documents, and participants aged 18 to 60 can provide their own valid identification documents.
(3) Participants aged 10 to 17 and their guardians, as well as participants aged 18 to 60, can sign the form voluntarily to participate in the trial, fully understand the trial procedures, the risks of participating in the trial, and other intervention measures that can be chosen if they do not participate in the trial, etc.
(4) Possess basic reading and writing skills, and be capable of reading, understanding and filling in diary cards and contact cards; (5) Female participants with fertility must also meet the following conditions: 1) They have taken effective measures within two weeks prior to participating in this trial; 2) Have no plans to have children within 6 months from the start of participating in this trial until the full vaccination. 3) Understand and agree to take effective contraceptive measures during the trial period (from the first dose to within 6 months after the full vaccination). Effective contraceptive measures include: condoms (for men), intrauterine devices, oral contraceptives (excluding emergency contraceptives), sterilization, abstention, injection or implantable contraception, sustained-release local contraceptives, hormone patches, diaphragms, cervical caps, etc. External ejaculation and safe period contraception are not regarded as effective contraceptive measures.
Exclusion Criteria:
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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The Participants received 1 dose of Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried each at day 0, 3, 7, 14 and 28, with a total of 5 doses.
Biological: Freeze-dried human rabies vaccine (human diploid cells)
The Participants received 1 dose of Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried each at day 0, 3, 7, and14, with a total of 4 doses.
Biological: Freeze-dried human rabies vaccine (human diploid cells)
The Participants received 1 dose of Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried each at day 0, 3, 7 and 28, with a total of 4 doses.
Biological: Freeze-dried human rabies vaccine (human diploid cells)
The Participants received 2 doses of Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried on day 0, 1 dose on day 7 and 1 dose on day 21, a total of 4 doses.
Biological: Freeze-dried human rabies vaccine (human diploid cells)
The Participants received 1 dose of Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried each at day 0, 3, 7, 14 and 28, with a total of 5 doses.
Biological: Freeze-dried human rabies vaccine (human diploid cells)
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
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
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
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
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
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
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
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
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
Antibody SCR for the simple 4-dose schedule group 2 of the trial vaccine and the 5-dose schedule group of the control vaccine
Antibody seroconversion rates in the simple 4-dose schedule group 2 of the trial vaccine and in the 5-dose group of the control vaccine.
Time frame: 14 days after the first dose
Antibody GMC for the simple 4-dose schedule group 2 of the trial vaccine and the 5-dose schedule group of the control vaccine
Antibody Geometric Mean Concentration in the simple 4-dose schedule group 2 of the trial vaccine and in the 5-dose group of the control vaccine.
Time frame: 14 days after the first dose
Antibody SCR for the 2-1-1 schedule group of the trial vaccine and the 5-dose schedule group of the control vaccine
Antibody seroconversion rates in the 2-1-1 schedule group of the trial vaccine and in the 5-dose group of the control vaccine.
Time frame: 14 days after the first dose
Antibody GMC for the 2-1-1 schedule group of the trial vaccine and the 5-dose schedule group of the control vaccine
Antibody Geometric Mean Concentration in the 2-1-1 schedule group of the trial vaccine and in the 5-dose group of the control vaccine.
Time frame: 14 days after the first dose
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 full vaccination
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 full vaccination
Antibody SCR for the simple 4-dose schedule group 2 of the trial vaccine and the 5-dose schedule group of the control vaccine
Antibody seroconversion rates in the simple 4-dose schedule group 2 of the trial vaccine and in the 5-dose group of the control vaccine.
Time frame: 14 days after full vaccination
Antibody SCR for the 2-1-1 schedule group of the trial vaccine and the 5-dose schedule group of the control vaccine
Antibody seroconversion rates in the 2-1-1 schedule group of the trial vaccine and in the 5-dose group of the control vaccine.
Time frame: 14 days after full vaccination
Start is estimated for Jul 2025; primary completion for Sep 2025, 1 month later.
Of 19 phase 3 interventional studies under Rabies, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 21. This study's planned 1 month is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Ningbo Rongan Biological Pharmaceutical Co., Ltd.