RabiesPhase 3NCT05969626
Clinical Trial of Freeze-dried Human Rabies Vaccine (Without Serum Vero Cells)
A Phase 3 study testing 5-dose group of test vaccine, 4-dose A group of test vaccine and 4-dose B group of test vaccine in people with Rabies, run by Ningbo Rongan Biological Pharmaceutical Co., Ltd. at 4 sites in China.
Trial summary
This study was intended to explore the safety and immunogenicity of the test vaccine compared to the control vaccine. The trial consisted of two phases. Phase I used an open-ended design. 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?
- 5-dose group of test vaccine, 4-dose A group of test vaccine and 4-dose B group of test vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,460 participants
- Where
- 4 sitesChina
- Study dates
- Aug 2023to Dec 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- The age of the subject is 10-60 years old (≥10 years old, <61 years old);
- Subjects aged 10-17 and their guardians can provide valid identification; subjects aged 18-60 can provide valid identification;
- Subjects aged 10-17 and at least one of their guardians voluntarily participate with informed consent, and sign the Informed Consent for minors and adults respectively; Subjects aged 18-60 voluntarily participate with informed consent and sign the adult version of Informed Consent; Basic reading and writing skills are required;
- If the subjects are WOCBP (women of childbearing potential), they should not be pregnant or breastfeeding, have a negative urine pregnancy test before vaccination, and have taken effective contraceptive measures within 2 weeks before being enrolled in this study; From enrollment in the study until 6 months after full exemption, no family planning and consent to use effective contraception during the study period. Effective forms of birth control include: oral contraceptives (excluding emergency contraceptives)Injectable or embedded contraception, sustained release topical contraceptives, hormonal patches, intrauterine devices, sterilization, abstinence, condoms (male), isolationMembrane, cervical cap, etc.;
- * On the day of enrollment, armpit body temperature of subjects >14 years old was <37.3℃, and armpit body temperature of subjects <14 years old was <37.5℃;
- Adult subjects or minor subjects and their guardians shall comply with the requirements of the clinical study protocol.
Who cannot join
- A history of rabies vaccine immunization or rabies virus passive immunization was asked;
- A history of grade 2 or 3 injury in animals susceptible to rabies virus (cats, dogs, etc.) within 12 months prior to the first dose of vaccination (the assessment criteria was the Technical Guidelines for Rabies Prevention and Control (2016));
- Plan to participate in other clinical trials during the clinical study;
- Allergic to any component of the test vaccine; History of severe allergies that require medical intervention, such as anaphylactic shock, allergic laryngeal edema, anaphylactoid purpura, thrombocytopenic purpura, allergic necrosis reaction (Arthus reaction), severe urticaria, dyspnea, angioneurotic edema, etc.;
- Have been diagnosed with a congenital or acquired immunodeficiency disease, such as HIV infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other immune disease that the investigator has determined may affect the evaluation of the trial;
- Known or suspected serious medical conditions upon inquiry include: severe respiratory diseases, poorly controlled chronic diseases, severe liver and kidney diseases, severe cardiovascular diseases, malignant tumors, etc.;
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- * Medically unmanageable hypertension, such as systolic blood pressure >120mmHg and/or diastolic blood pressure >80mmHg in subjects 10 to 17 years of age prior to enrollment, systolic blood pressure of 140mmHg and/or diastolic blood pressure of 90mmHg in subjects 18 years of age and older;
- Coagulation dysfunction (e.g. coagulation factor deficiency, coagulation disorders, platelet abnormalities) or coagulation disorders diagnosed by a physician;
- Asplenia, functional asplenia, and any condition resulting in asplenia or splenectomy;
- Have received immunosuppressive therapy within 3 months prior to vaccination or plan to receive immunosuppressive therapy throughout the study period;
- Plan to receive such treatment within 30 days after the first dose to the full dose, such as long-term systemic glucocorticoid therapy (2 weeks or more at a dose of >2mg/kg/ day or >20mg/ day of prednisone or equivalent); Allow topical use (such as ointment, eye drops, inhalants or nasal sprays);
- * Received immunoglobulins or blood-related products within 3 months prior to vaccination or plan to receive them throughout the study period;
- * Acute illness or acute onset of chronic disease within 3 days prior to vaccination;
- * Antipyretic, analgesic and anti-allergic drugs were used within 3 days prior to vaccination;
- * Have received COVID-19 vaccine or live attenuated vaccine within 28 days prior to vaccination, and have received inactivated vaccines other than COVID-19 inactivated vaccines within 14 days prior to vaccination;
- Previous or current diagnosis of neurological or psychiatric disorders (including but not limited to dementia, schizophrenia, bipolar disorder, etc.) or confirmed Seizures, convulsions (excluding febrile convulsions in children 5 years of age and younger)), and other neuropsychiatric disorders deemed unsuitable for participation in this study by the investigator;
- Due to various medical, psychological, social, or other conditions that, in the judgment of the investigator, are inconsistent with the study protocol or cannot be complied with.
- For the criteria marked with an (), if the subject has the conditions specified in that criteria, the visit may be rescheduled when those conditions are no longer present.
- In addition to the examination items set by the protocol, other medical history, surgical history, and medication history were obtained in the form of consultation.
- Criteria for subsequent dose delays:If any of the following conditions occur before any subsequent dose of the subject, the vaccination should be postponed until the vaccination requirements are met.
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- On the day of vaccination, the axillary temperature is measured at 37.3℃ for subjects >14 years old and 37.5℃ for subjects <14 years old.
- Acute illness or acute onset of chronic disease within 3 days prior to vaccination;
- Other conditions for which investigators decide vaccination should be delayed. Exclusion criteria for subsequent dose vaccination:If any of the following occurs during the study safety observation period, subjects may not continue with vaccination, but may continue with other study steps at the discretion of the investigator.
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- Newly discovered or newly occurred before vaccination that did not meet the inclusion criteria (except items with *);
- Meet the exclusion criteria for the first dose (except for items with *);
- Vaccination-related adverse events occur after vaccination and subsequent doses are not considered appropriate by investigators;
- The investigator determines any circumstances that require discontinuation of vaccination from a subject risk and benefit perspective.
- Incomplete full immunization;
- Vaccination with rabies immunoglobulin or other rabies vaccines within 12 months after full immunization;
- Long-term use (>15 days) of immunosuppressants or other immunomodulatory drugs (such as glucocorticoids) within 12 months after full vaccination;
- Any other circumstances that the investigator believes may affect the evaluation of the trial.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Sichuan Center for Disease Control and Prevention
Chengdu, Sichuan, 610041
Ting Huang, 13330993324, cocoht@163.com
Center for Disease Control and Prevention, Mianyang City
Mianyang, Sichuan, 621000
Youquan Liu, 13608120046
Shizhong District, Neijiang City Center for Disease Control and Prevention
Neijiang, Sichuan, 511002
Ling Zhong, 18981435233
Rongxian Center for Disease Control and Prevention
Zigong, Sichuan, 643199
Zaixing Li, 18990015566
About this study
Official title: A Randomized, Blinded, Parallel Controlled Phase 3 Clinical Trial to Evaluate the Immunogenicity and Safety of Freeze-dried Human Rabies Vaccine (Without Serum Vero Cells) Administered to People Aged 10-60 Years With Different Immunization Procedures
This study was intended to explore the safety and immunogenicity of the test vaccine compared to the control vaccine. The trial consisted of two phases.
Phase I used an open-ended design. Phase II used a randomized, blinded, parallel-controlled non-inferiority design with the same type of active vaccine, in which the control vaccine 5-dose group and the test vaccine 5 group were kept blinded throughout, the test vaccine 4-dose B group was kept blinded from the other three groups until visit 4 （D14）, and the test vaccine 4-dose A group was kept blinded from the control vaccine 5-dose group and the test vaccine 5-dose group until visit 5 （D28）.
- Conditions
- Rabies
- Being tested
- 5-dose group of test vaccine, 5-dose group of control vaccine, 4-dose A group of test vaccine, 4-dose B group of test vaccine
- Medical subject headings
- Rabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-dose group of test vaccineBiological
Subjects will be vaccinated on days 0, 3, 7, 14, and 28
5-dose group of control vaccineBiological
Subjects will be vaccinated on days 0, 3, 7, 14, and 28
4-dose A group of test vaccineBiological
Subjects will be vaccinated on days 0, 3, 7, 14
4-dose B group of test vaccineBiological
Subjects will be vaccinated on days 0, 3, 7, 28
| Study group | Role | What they receive |
|---|---|---|
| 5-dose group of test vaccine | Experimental | Not described Receives: Biological: 5-dose group of test vaccine |
| 5-dose group of control vaccine | Active comparator | Not described Receives: Biological: 5-dose group of control vaccine |
| 4-dose A group of test vaccine | Experimental | Not described Receives: Biological: 4-dose A group of test vaccine |
| 4-dose B group of test vaccine | Experimental | Not described Receives: Biological: 4-dose B group of test vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody SCR in 5-dose groups of test vaccine and 5-dose groups of control vaccine
Antibody Seroconversion rate in 5-dose groups of test vaccine and 5-dose groups of control vaccine
Measured: Day 14
Antibody GMC in 5-dose groups of test vaccine and 5-dose groups of control vaccine
Antibody Geometric Mean Concentration in 5-dose groups of test vaccine and 5-dose groups of control vaccine
Measured: Day 14
Antibody SCR in 4-dose groups of test vaccine and 5-dose groups of control vaccine
Antibody Seroconversion rate in 4-dose groups of test vaccine and 5-dose groups of control vaccine
Measured: Day 14
Antibody GMC in 4-dose groups of test vaccine and 5-dose groups of control vaccine
Antibody Geometric Mean Concentration in 4-dose groups of test vaccine and 5-dose groups of control vaccine
Measured: Day 14
Antibody SCR in 5-dose groups of test vaccine and 5-dose groups of control vaccine
Antibody Seroconversion rate in 5-dose groups of test vaccine and 5-dose groups of control vaccine
Measured: Day 42
Antibody SCR in 4-dose groups of test vaccine and 5-dose groups of control vaccine
Antibody Seroconversion rate in 4-dose groups of test vaccine and 5-dose groups of control vaccine
Measured: Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study startAug 2023 (estimated)
- Primary completionApr 2024 (estimated)
- Study completionDec 2024 (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
- 2,460 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
- NCT05969626
- Sponsor's protocol ID
- AIM1813-III
- Status last verified
- Jul 2023
- First submitted
- 23 Jul 2023
- Last updated
- 9 Aug 2023
- 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 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Blinded, Parallel Controlled Phase 3 Clinical Trial to Evaluate the Immunogenicity and Safety of Freeze-dried Human Rabies Vaccine (Without Serum Vero Cells) Administered to People Aged 10-60 Years With Different Immunization Procedures
- ClinicalTrials.gov ID
- NCT05969626
- Acronym / sponsor ID
- AIM1813-III
- Conditions
- Rabies
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,460 participants (estimated)
- Lead sponsor
- Ningbo Rongan Biological Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2023 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 1 Aug 2023 (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.
This study was intended to explore the safety and immunogenicity of the test vaccine compared to the control vaccine. The trial consisted of two phases.
Phase I used an open-ended design. Phase II used a randomized, blinded, parallel-controlled non-inferiority design with the same type of active vaccine, in which the control vaccine 5-dose group and the test vaccine 5 group were kept blinded throughout, the test vaccine 4-dose B group was kept blinded from the other three groups until visit 4 （D14）, and the test vaccine 4-dose A group was kept blinded from the control vaccine 5-dose group and the test vaccine 5-dose group until visit 5 （D28）.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 5-dose group of test vaccine | Experimental | Biological: 5-dose group of test vaccine |
| 5-dose group of control vaccine | Active comparator | Biological: 5-dose group of control vaccine |
| 4-dose A group of test vaccine | Experimental | Biological: 4-dose A group of test vaccine |
| 4-dose B group of test vaccine | Experimental | Biological: 4-dose B group of test vaccine |
Who may qualify
- Ages
- 10 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- The age of the subject is 10-60 years old (≥10 years old, <61 years old);
- Subjects aged 10-17 and their guardians can provide valid identification; subjects aged 18-60 can provide valid identification;
- Subjects aged 10-17 and at least one of their guardians voluntarily participate with informed consent, and sign the Informed Consent for minors and adults respectively; Subjects aged 18-60 voluntarily participate with informed consent and sign the adult version of Informed Consent; Basic reading and writing skills are required;
- If the subjects are WOCBP (women of childbearing potential), they should not be pregnant or breastfeeding, have a negative urine pregnancy test before vaccination, and have taken effective contraceptive measures within 2 weeks before being enrolled in this study; From enrollment in the study until 6 months after full exemption, no family planning and consent to use effective contraception during the study period. Effective forms of birth control include: oral contraceptives (excluding emergency contraceptives)Injectable or embedded contraception, sustained release topical contraceptives, hormonal patches, intrauterine devices, sterilization, abstinence, condoms (male), isolationMembrane, cervical cap, etc.;
- * On the day of enrollment, armpit body temperature of subjects >14 years old was <37.3℃, and armpit body temperature of subjects <14 years old was <37.5℃;
Key exclusion criteria (33 listed)
- For the criteria marked with an (), if the subject has the conditions specified in that criteria, the visit may be rescheduled when those conditions are no longer present.
- In addition to the examination items set by the protocol, other medical history, surgical history, and medication history were obtained in the form of consultation.
- Criteria for subsequent dose delays:If any of the following conditions occur before any subsequent dose of the subject, the vaccination should be postponed until the vaccination requirements are met.
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- <!-- -->
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 |
|---|---|---|
| 5-dose group of test vaccineSubjects will be vaccinated on days 0, 3, 7, 14, and 28 | Biological | 5-dose group of test vaccine |
| 5-dose group of control vaccineSubjects will be vaccinated on days 0, 3, 7, 14, and 28 | Biological | 5-dose group of control vaccine |
| 4-dose A group of test vaccineSubjects will be vaccinated on days 0, 3, 7, 14 | Biological | 4-dose A group of test vaccine |
| 4-dose B group of test vaccineSubjects will be vaccinated on days 0, 3, 7, 28 | Biological | 4-dose B group of test vaccine |
Primary outcome
Antibody SCR in 5-dose groups of test vaccine and 5-dose groups of control vaccine
Time frame: Day 14
Antibody Seroconversion rate in 5-dose groups of test vaccine and 5-dose groups of control vaccine
Antibody GMC in 5-dose groups of test vaccine and 5-dose groups of control vaccine
Time frame: Day 14
Antibody Geometric Mean Concentration in 5-dose groups of test vaccine and 5-dose groups of control vaccine
Antibody SCR in 4-dose groups of test vaccine and 5-dose groups of control vaccine
Time frame: Day 14
Antibody Seroconversion rate in 4-dose groups of test vaccine and 5-dose groups of control vaccine
Antibody GMC in 4-dose groups of test vaccine and 5-dose groups of control vaccine
Time frame: Day 14
Antibody Geometric Mean Concentration in 4-dose groups of test vaccine and 5-dose groups of control vaccine
Antibody SCR in 5-dose groups of test vaccine and 5-dose groups of control vaccine
Time frame: Day 42
Antibody Seroconversion rate in 5-dose groups of test vaccine and 5-dose groups of control vaccine
Antibody SCR in 4-dose groups of test vaccine and 5-dose groups of control vaccine
Time frame: Day 42
Antibody Seroconversion rate in 4-dose groups of test vaccine and 5-dose groups of control vaccine
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
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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. This study is not recruiting at the moment.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 5-dose group of test vaccine, 4-dose A group of test vaccine and 4-dose B group of test vaccine in people with Rabies, run by Ningbo Rongan Biological Pharmaceutical Co., Ltd. at 4 sites 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 6 inclusion and 33 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: status not confirmed, as of the sponsor's last update on 9 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ting Huang (13330993324, cocoht@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibody SCR in 5-dose groups of test vaccine and 5-dose groups of control vaccine (time frame: Day 14). The study lists 6 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 9 Aug 2023.