A Phase 3 interventional study of Freeze-dried human rabies vaccine (Vero cells) Zhifeilongkoma - 5-dose program and Freeze-dried human rabies vaccine (Vero cells) Zhifeilongkoma - 4-dose program in Rabies Vaccine Adverse Reaction and Safety and Efficacy, sponsored by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.. Active, not recruiting at 1 site in China. Open to participants aged 10 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-24.
Sponsored by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. (part of Chongqing Zhifei Biological Products Co., Ltd.) · Phase 3, Interventional, and Prevention
This clinical trial is carried out in two phases. The first phase adopts an open design, and the second phase adopts a randomized, blinded, and similar vaccine-controlled non-inferiority trial design.
The first stage: According to the order of two age groups of 18-60 years old and 10-17 years old, 40 cases were enrolled in each age group (20 persons for the 5-dose program and 20 for the 4-dose program). Subjects in the 5-dose group received 1 dose of test vaccine on 0, 3, 7, 14, and 28 days each. Subjects in the 4-dose group received 1 dose each on both arms on day 0, and 1 dose on day 7 and day 21 each. All subjects in the first stage were only observed for safety and were followed up to 6 months after the entire course of vaccination.
The second stage: the total number of enrolled 2400 cases, 10-60 years old, the 4-dose program group and the 5-dose program group of the test vaccine, the 4-dose program group and the 5-dose program group of the control vaccine according to the random ratio 1:1:1:1. Among the total number of participants, 1680 cases (420 cases per group) were simultaneously observed for immunogenicity and safety, and the remaining 720 subjects (180 cases per group) only underwent safety observation. 800 subjects (200 cases in each group) received 6-month immune persistence observation after full vaccination, and 400 subjects in the test vaccine group received 12 months immune persistence observation after full vaccination.
In the second stage, 1680 subjects were collected before the immunization, 7 days after the first dose, 14 days after the first dose, and 14 days after the full vaccination to test rabies virus antibodies to evaluate the immunogenicity of the test vaccine. 800 subjects were in the whole process Immune persistent blood sampling was performed 6 months after vaccination, and subjects in the test vaccine group were further subjected to immune persistent blood sampling 12 months after the full course of vaccination to evaluate immune durability. Collect all AEs within 30 minutes after each dose, AEs from 0-7 days, all non-collective AEs from the first dose to 30 days after the full course of vaccination, and all serious AEs from the first dose to 6 months after the full course of vaccination Adverse events.
114 studies on the registry are indexed under Rabies; 15 are open to participants now.
This study's planned enrollment of 2,480 is above the median of 201 across 104 interventional studies indexed under Rabies.
Browse Rabies studies →Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. is the lead sponsor of 49 studies on the registry; 4 are open to participants now.
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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.
Exclusion Criteria:
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.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Freeze-dried human rabies vaccine (Vero cells), 0.5ml after reconstitution, with a titer of not less than 2.5IU, Anhui Zhifeilongkoma Biopharmaceutical Co., Ltd.
Biological: Freeze-dried human rabies vaccine (Vero cells) Zhifeilongkoma - 5-dose program
Freeze-dried human rabies vaccine (Vero cells), 0.5ml after reconstitution, with a titer of not less than 2.5IU, Anhui Zhifeilongkoma Biopharmaceutical Co., Ltd.
Biological: Freeze-dried human rabies vaccine (Vero cells) Zhifeilongkoma - 4-dose program
Freeze-dried human rabies vaccine (Vero cells), 0.5ml after reconstitution, titer not less than 2.5IU, Liaoning Chengda Biological Co., Ltd.
Biological: Freeze-dried human rabies vaccine (Vero cells) Chengda - 5-dose program
Freeze-dried human rabies vaccine (Vero cells), 0.5ml after reconstitution, titer not less than 2.5IU, Liaoning Chengda Biological Co., Ltd.
Biological: Freeze-dried human rabies vaccine (Vero cells) Chengda - 4-dose program
Inoculate 1 dose of Investigational vaccine each on 0, 3, 7, 14, 28 days, by intramuscular injection of deltoid muscle of upper arm
Inoculate 1 dose of Investigational vaccine each on both arms on day 0, and 1 dose each on day 7 and 21, by intramuscular injection of deltoid muscle of upper arm
Inoculate 1 dose of control vaccine each on 0, 3, 7, 14, 28 days, by intramuscular injection of deltoid muscle of upper arm
Inoculate 1 dose of control vaccine each on both arms on day 0, and 1 dose each on day 7 and 21, by intramuscular injection of deltoid muscle of upper arm
Antibody positive conversion rate - Immunogenicity endpoint
Antibody positive conversion rate of the test group and the control group of the pre-immune antibody-negative population
Time frame: 14 days after the first dose of vaccination
Geometric mean concentration - Immunogenicity endpoint
Geometric mean concentration of the test group and the control group of the pre-immune antibody-negative population
Time frame: 14 days after the first dose of vaccination
Incidence of Adverse Events [Safety and Tolerability]
Incidence of Adverse Events
Time frame: within 30 minutes after each dose of vaccination; the first dose of vaccination to 30 days after the full course of vaccination
Incidence of Serious Adverse Events [Safety and Tolerability]
Incidence of Serious Adverse Events
Time frame: The first dose of vaccination to 6 months after the full course of vaccination
Antibody positive conversion rate - Immunogenicity endpoint
Antibody positive conversion rate
Time frame: 7 days after the first dose of vaccination; 14 days, 6 months, 12 months after the full vaccination
Geometric mean concentration - Immunogenicity endpoint
Geometric mean concentration
Time frame: 7 days after the first dose of vaccination; 14 days, 6 months, 12 months after the full vaccination
Plan to share: No
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This study is active, not recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Vero cell line
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. →