A Phase 3 interventional study of Control vaccine and Experimental vaccine in Rabies Human, sponsored by Hualan Biological Bacterin Co. Ltd.. Completed at 1 site in China. Open to participants aged 9 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-20.
Sponsored by Hualan Biological Bacterin Co. Ltd. · Phase 3, Interventional, and Health services research
To evaluate the safety and immunogenicity of lyophilized human rabies vaccine (Vero cell) developed by Hualan Biological in healthy people aged 9 to 65 years with two different immunization schedules.
The trial to assess the rabies vaccine (Vero cells) in healthy group of 9 \~ 65 years old after inoculation, the first dose after 14 days and 14 days after inoculation 5 agent group turn antibody positive rate of bad effect on 5 agent in the control group; The safety profile, seroconversion rate, and geometric mean concentration of the four-dose vaccine were noninferior to those of the five-dose regimen at 14 days after the first dose. More people aged 9-65 in the first agent free after 7 days, 14 days and 14 days after inoculation, 5 patients and 5 doses in the control group, four patients and 5 doses group antibody positive rate, GMC and GMC growth multiples have differences. To evaluate whether the seroconversion rate of subjects in the 4-dose experimental group reached 100% 14 days after the whole course of vaccination.
114 studies on the registry are indexed under Rabies; 15 are open to participants now.
This study's enrollment of 1,956 is above the median of 201 across 104 interventional studies indexed under Rabies.
Browse Rabies studies →Hualan Biological Bacterin Co. Ltd. is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
First needle exclusion:
Subsequent needle exclusions:
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.
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A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A total of 1956 subjects were randomly divided into three groups at a ratio of 1:1:1, 652 subjects in each group were vaccinated with the test vaccine or the control vaccine on a schedule of 0, 3, 7, 14, 28 days (a total of 5 doses). Blood samples were collected from the subjects for antibody detection on 0, 7/14, 35/42 days, respectively.
Biological: Control vaccine · Biological: Experimental vaccine
An additional group of 652 people received the trial vaccine in a 0 -, 7 -, and 21-day schedule (two first doses for a total of four doses). Blood samples were collected at 0, 7/14 and 35/42 days for antibody detection, and all subjects were systematically observed for safety.
Biological: Experimental vaccine
A group of 652 subjects were vaccinated with the control vaccine at 0, 3, 7, 14 and 28 days (5 doses in total). Blood samples were collected from the subjects at 0, 7/14 and 35/42 days for antibody detection.
A total of 652 subjects received 5 doses of the vaccine at 0, 3, 7, 14 and 28 days. Blood samples were collected on 0, 7/14 and 35/42 days for antibody detection.
1956 subjects accept the observation of local adverse reaction according to Guidelines for grading standard of adverse reaction of clinical trial of vaccine used for prevention
Tenderness, pruritus, induration, redness, swelling and its degree of size and disturbance of body activity at the inoculation site
Time frame: Every needle 30 days after vaccination
1956 subjects accept the observation of local adverse reaction according to Guidelines for grading standard of adverse reaction of clinical trial of vaccine used for prevention
Tenderness, pruritus, induration, redness, swelling and its degree of size and disturbance of body activity at the inoculation site
Time frame: Vaccinations 31 days to 180 days
1956 subjects accept the observation of systemic adverse reactions according to Guidelines for grading standard of adverse reaction of clinical trial of vaccine used for prevention.
Fever, allergy, headache, fatigue, nausea and vomiting, diarrhea, muscle pain, arthralgia and so on were observed
Time frame: Every needle 30 days after vaccination
1956 subjects accept the observation of systemic adverse reactions according to Guidelines for grading standard of adverse reaction of clinical trial of vaccine used for prevention.
Fever, allergy, headache, fatigue, nausea and vomiting, diarrhea, muscle pain, arthralgia and so on were observed
Time frame: Vaccinations 31 days to 180 days
The immunogenicity was tested by immunofluorescence staining
The rabies virus antibody was detected by immunofluorescence focus method. The positive rate was defined as the serum antibody concentration ≥0.5IU/ml
Time frame: 5 agent group gathering subjects were 0, 7, 14, 42 days of blood samples
The immunogenicity was tested by immunofluorescence staining
The rabies virus antibody was detected by immunofluorescence focus method. The positive rate was defined as the serum antibody concentration ≥0.5IU/ml
Time frame: Blood samples were collected on day 0, 7, 14 and 35 in the 4-dose group
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2015 to primary completion in Dec 2015, 9 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 9 months is below that.
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This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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Hualan Biological Bacterin Co. Ltd.