A Phase 3 interventional study of Freeze-dried human rabies vaccine (MRC-5 cells) Zhifeilongkoma - 5-dose program and Freeze-dried human rabies vaccine (MRC-5 cells) Zhifeilongkoma - 4-dose program in Rabies Vaccine Adverse Reaction, sponsored by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.. Completed at 1 site in China. Open to participants aged 10 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-11.
Sponsored by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. (part of Chongqing Zhifei Biological Products Co., Ltd.) · Phase 3, Interventional, and Prevention
This trial is a randomized, blind, similar vaccine controlled, single center, non-inferiority design phase III clinical trial, with a study population of 10 to 60 years old, conducted in two stages.Phase 1 and Phase 2
This trial is a randomized, blind, similar vaccine controlled, single center, non-inferiority design phase III clinical trial, with a study population of 10 to 60 years old, conducted in two stages.
Phase 1: 40 adult subjects aged 18-60 were randomly assigned to receive the trial vaccine in a 1:1 ratio according to a 5-dose immunization program (0, 3, 7, 14, 28 days) or a 4-dose immunization program (0, 7, 21 days (2 doses for the first dose). The number of recipients for each immunization program was 20. All subjects in the adult group underwent a preliminary safety assessment 7 days after the first dose of vaccination (before the third dose of vaccine), but did not meet the suspension/termination criteria. A further 40 underage subjects aged 10-17 were enrolled in the same order as the adult group, and all subjects underwent a preliminary safety assessment 7 days after the full dose of vaccination. If they did not meet the suspension/termination criteria, they entered the second phase of the study.
Phase 2: A total of 1800 subjects aged 10 to 60 years old were randomly assigned to three groups in a 1:1:1 ratio, namely the 5-dose experimental group (vaccinated with the 5-dose program), the 5-dose control group (vaccinated with the 5-dose program), and the 4-dose experimental group (vaccinated with the 4-dose program). All subjects collected blood samples before the first dose, 7 days after the first dose, 14 days after the first dose, and 14 days after the entire dose for immunogenicity evaluation; Subjects who meet the requirements for immune persistence observation in the plan shall collect blood samples 3 months after the full vaccination, and the experimental group subjects shall also collect blood samples 12 months after the full vaccination for immune persistence evaluation.
Collect all AEs from participants within 30 minutes after each dose, collected AEs within 0-7 days after each dose (if the interval from the current dose to the next dose is less than 7 days, the collection period shall be based on the actual interval between the two doses), all non collected AEs within 30 days after the first dose to the entire dose, and all serious adverse events (SAE) within 6 months after the first dose to the entire dose.
114 studies on the registry are indexed under Rabies; 15 are open to participants now.
This study's enrollment of 1,880 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.
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.
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.
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.
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.
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.
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.
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.
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 (MRC-5 cells), 1.0 ml after reconstitution, with a titer of not less than 5.24 IU, Anhui Zhifeilongkoma Biopharmaceutical Co., Ltd.
Biological: Freeze-dried human rabies vaccine (MRC-5 cells) Zhifeilongkoma - 5-dose program
Freeze-dried human rabies vaccine (MRC-5 cells), 1.0 ml after reconstitution, with a titer of not less than 5.24 IU, Anhui Zhifeilongkoma Biopharmaceutical Co., Ltd.
Biological: Freeze-dried human rabies vaccine (MRC-5 cells) Zhifeilongkoma - 4-dose program
Freeze-dried human rabies vaccine (MRC-5 cells), 1.0 ml after reconstitution, with a titer of not less than 4.57 IU, ,Chengdu Kanghua Biological Products Co., Ltd
Biological: Freeze-dried human rabies vaccine (MRC-5 cells) Kanghua - 5-dose program
Freeze-dried human rabies vaccine (MRC-5 cells), 1.0 ml after reconstitution, with a titer of not less than 4.57 IU, ,Chengdu Kanghua Biological Products Co., Ltd
Biological: Freeze-dried human rabies vaccine (MRC-5 cells) Kanghua - 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 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
Antibody positive conversion rate - Immunogenicity endpoint
Antibody positivity conversion rates in the 4-dose experimental group, 5-dose experimental group, and 5-dose control group
Time frame: up to 14 days after the first/full dose of vaccination
Geometric mean concentration - Immunogenicity endpoint
GMC of the 4-dose experimental group, 5-dose experimental group, and 5-dose control group
Time frame: 14 days after the first/full dose of vaccination
Incidence of Adverse Events [Safety and Tolerability]
The incidence of any local and systemic adverse events (AEs)
Time frame: within 30 minutes after each dose of vaccination
Incidence of Adverse Events [Safety and Tolerability]
The incidence of collected AEs
Time frame: within 0-7 days after each dose of vaccination
Incidence of Adverse Events [Safety and Tolerability]
The incidence of non solicited AE
Time frame: within 30 days after the first dose of vaccination to the full course of vaccination
Incidence of Adverse Events [Safety and Tolerability]
The incidence of all serious adverse events (SAE)
Time frame: within 6 months after the first dose administration and the entire vaccination process
Antibody positive conversion rate - Immunogenicity endpoint
Antibody positivity conversion rates in the 4-dose experimental group, 5-dose experimental group, and 5-dose control group
Time frame: 7 days after the first dose of vaccination；3 month after full dose of vaccination；
Geometric mean concentration - Immunogenicity endpoint
GMC of the 4-dose experimental group, 5-dose experimental group, and 5-dose control group
Time frame: 7 days after the first dose of vaccination;3 month after full dose of vaccination；
Antibody positive conversion rate - Immunogenicity endpoint
Antibody positivity in the 5-dose and 4-dose test groups
Time frame: 12 month after full dose of vaccination；
Geometric mean concentration - Immunogenicity endpoint
GMC of the 5-dose and 4-dose test groups
Time frame: 12 month after full dose of vaccination；
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2019 to primary completion in Jul 2021, 21 months.
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 21 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. →