RabiesPhase 3NCT07028801
Clinical Trial of Freeze-dried Human Rabies Vaccine (Human Diploid Cells)
A Phase 3 study testing Freeze-dried human rabies vaccine (human diploid cells) in people with Rabies, run by Ningbo Rongan Biological Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 10 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Rabies
- What is being tested?
- Freeze-dried human rabies vaccine (human diploid cells)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 31 Jul 2025to 31 Mar 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- (1) The participants' ages range from 10 to 60 years old (≥10 years old and <61 years old).
- 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.
- Participants aged 10 to 17 and their guardians, as well as participants aged 18 to 60, can sign the informed consent 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.
- 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 contraceptive 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.
Who cannot join
- 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℃*;
- Women who have a positive urine pregnancy trial before vaccination (on the day of vaccination), or who, after assessment, cannot rule out the possibility of pregnancy or are breastfeeding;
- Hypertension that cannot be controlled by medication, such as systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg for participants aged 18 years and above before enrollment;
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- Allergy to any component of the vaccine used in the trial, such as human albumin, sucrose, or maltose;
- Those with a history of severe allergies in the past, such as anaphylactic shock, allergic laryngeal edema, allergic purpura, local allergic necrosis reaction (Arthus reaction), severe urticaria, allergic bronchitis, acquired angioedema, etc.
- Has been diagnosed with congenital or acquired immune system diseases, such as the Human Immunodeficiency Virus. HIV infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease or other immune diseases that the researcher deems likely to affect the trial assessment;
- Known or suspected of having serious diseases, including severe respiratory diseases, liver and kidney diseases, cardiovascular and cerebrovascular diseases, malignant tumors, and other chronic diseases that are poorly controlled, etc.
- Abnormal coagulation function (such as deficiency of coagulation factors, coagulation disorders, abnormal platelets) or coagulation disorders diagnosed by a doctor;
- Anplenia or functional anplenia, as well as anplenia or splenectomy caused by any circumstances;
- Previous or current clearly diagnosed neurological or mental disorders (including but not limited to dementia, schizophrenia, bipolar disorder, etc.) or confirmed epilepsy, convulsions, as well as other neurological or mental disorders that the researcher deems unsuitable for participation in this trial;
- It is planned to receive such treatment from the first dose of vaccination to 30 days after the full vaccination course, such as long-term systemic glucocorticoid therapy (used continuously for 2 weeks or more, at a dose of ³2mg/kg/ day or ³20mg/ day prednisone or equivalent doses); Local medications (such as ointments, eye drops, inhalants or nasal sprays) are allowed;
- Have received or plan to receive immunoenhancers or inhibitors, immunoglobulins or blood-related products throughout the trial period within 3 months prior to enrollment;
- Have received attenuated live vaccines within 14 days before enrollment, and subunit vaccines or inactivated vaccines within 7 days *;
- Within 3 days before enrollment, have suffered from acute diseases or be in the acute attack stage of chronic diseases *;
- Antipyretic, analgesic and antihistamine drugs were used within 3 days before enrollment.
- Currently participating in or planning to participate in other clinical trials during this clinical trial;
- According to the researcher's judgment, due to various medical, psychological, social conditions or other circumstances contrary to the trial protocol, or the participants' inability to comply with the requirements of the trial protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Henan Provincial Center for Disease Control and Prevention
Zhengzhou, Henan, 450000
Zhiqiang Xie, +8613526534586, xiezqshang@163.com
About this study
Official title: A Randomized, Blinded, Parallel Controlled, Non-inferiority Design Phase III Clinical Trial to Evaluate the Immunogenicity and Safety of Freeze-dried Human Rabies Vaccine (Human Diploid Cells) Administered to Participants Aged 10 to 60 Years With Different Immunization Schedules
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.
Read the detailed description
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.
- Conditions
- Rabies
- Being tested
- Freeze-dried human rabies vaccine (human diploid cells)
- Medical subject headings
- Rabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freeze-dried human rabies vaccine (human diploid cells)Biological
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
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
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
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
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
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | 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. Receives: Biological: Freeze-dried human rabies vaccine (human diploid cells) |
| group 2 | Experimental | 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. Receives: Biological: Freeze-dried human rabies vaccine (human diploid cells) |
| group 3 | Experimental | 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. Receives: Biological: Freeze-dried human rabies vaccine (human diploid cells) |
| group 4 | Experimental | 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. Receives: Biological: Freeze-dried human rabies vaccine (human diploid cells) |
| group 5 | Active comparator | 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. Receives: Biological: Freeze-dried human rabies vaccine (human diploid cells) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 14 days after full vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start31 Jul 2025 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RabiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ningbo Rongan Biological Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07028801
- Sponsor's protocol ID
- AIM2301-Ⅲ-01
- Status last verified
- Jun 2025
- First submitted
- 3 Jun 2025
- Last updated
- 19 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Blinded, Parallel Controlled, Non-inferiority Design Phase III Clinical Trial to Evaluate the Immunogenicity and Safety of Freeze-dried Human Rabies Vaccine (Human Diploid Cells) Administered to Participants Aged 10 to 60 Years With Different Immunization Schedules
- ClinicalTrials.gov ID
- NCT07028801
- Acronym / sponsor ID
- AIM2301-Ⅲ-01
- Conditions
- Rabies
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Ningbo Rongan Biological Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Jul 2025 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 19 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | 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. |
| group 2 | Experimental | 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. |
| group 3 | Experimental | 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. |
| group 4 | Experimental | 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. |
| group 5 | Active comparator | 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. |
Who may qualify
- Ages
- 10 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- (1) The participants' ages range from 10 to 60 years old (≥10 years old and <61 years old).
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Biological | group 1 |
| Freeze-dried human rabies vaccine (human diploid cells)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 | Biological | group 2 |
| Freeze-dried human rabies vaccine (human diploid cells)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 | Biological | group 3 |
| Freeze-dried human rabies vaccine (human diploid cells)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 | Biological | group 4 |
| Freeze-dried human rabies vaccine (human diploid cells)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 | Biological | group 5 |
Primary outcome
Antibody SCR for the 5-dose schedule group of the trial vaccine and the 5-dose schedule group of the control vaccine
Time frame: 14 days after the first dose
Antibody seroconversion rates in the 5-dose schedule group of the trial vaccine and the 5-dose control vaccine group.
Antibody GMC for the 5-dose schedule group of the trial vaccine and the 5-dose schedule group of the control vaccine
Time frame: 14 days after the first dose
Antibody Geometric Mean Concentration in the 5-dose schedule group of the trial vaccine and the 5-dose control vaccine group.
Antibody SCR for the simple 4-dose schedule group 1 of the trial vaccine and the 5-dose schedule group of the control vaccine
Time frame: 14 days after the first dose
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.
Antibody GMC for the simple 4-dose schedule group 1 of the trial vaccine and the 5-dose schedule of the control vaccine
Time frame: 14 days after the first dose
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.
Antibody SCR for the simple 4-dose schedule group 2 of the trial vaccine and the 5-dose schedule group of the control vaccine
Time frame: 14 days after the first dose
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.
Antibody GMC for the simple 4-dose schedule group 2 of the trial vaccine and the 5-dose schedule group of the control vaccine
Time frame: 14 days after the first dose
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.
Antibody SCR for the 2-1-1 schedule group of the trial vaccine and the 5-dose schedule group of the control vaccine
Time frame: 14 days after the first dose
Antibody seroconversion rates in the 2-1-1 schedule group of the trial vaccine and in the 5-dose group of the control vaccine.
Antibody GMC for the 2-1-1 schedule group of the trial vaccine and the 5-dose schedule group of the control vaccine
Time frame: 14 days after the first dose
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.
Antibody SCR for the 5-dose schedule group of the trial vaccine and the 5-dose schedule group of the control vaccine
Time frame: 14 days after full vaccination
Antibody seroconversion rates in the 5-dose schedule group of the trial vaccine and the 5-dose control vaccine group.
Antibody SCR for the simple 4-dose schedule group 1 of the trial vaccine and the 5-dose schedule group of the control vaccine
Time frame: 14 days after full vaccination
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.
Antibody SCR for the simple 4-dose schedule group 2 of the trial vaccine and the 5-dose schedule group of the control vaccine
Time frame: 14 days after full vaccination
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.
Antibody SCR for the 2-1-1 schedule group of the trial vaccine and the 5-dose schedule group of the control vaccine
Time frame: 14 days after full vaccination
Antibody seroconversion rates in the 2-1-1 schedule group of the trial vaccine and in the 5-dose group of the control vaccine.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Freeze-dried human rabies vaccine (human diploid cells) in people with Rabies, run by Ningbo Rongan Biological Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhiqiang Xie (+8613526534586, xiezqshang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibody SCR for the 5-dose schedule group of the trial vaccine and the 5-dose schedule group of the control vaccine (time frame: 14 days after the first dose). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.