To Evaluate the Immunogenicity and Safety of Two Different Immunization Schedules of Rabies Vaccine (Vero Cell)

Rabies Human Clinical Trial

— rabies  

Official title:

Evaluation With Rabies Vaccine (Vero Cell) of Two Different Immune Procedure in the Healthy Crowd the Immunogenicity and Safety of Randomized, Blinded, Similar Vaccine Against Ⅲ Phase of Clinical Trials

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06177249
• Other study ID #: 2014L00266
• Status: Completed
• Phase: Phase 3
• Start date: March 15, 2015
• Est. completion date: May 1, 2016

Study information

• Verified date: March 2015
• Source: Hualan Biological Bacterin Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1956
• Est. completion date: May 1, 2016
• Est. primary completion date: December 16, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 65 Years

Eligibility

Inclusion Criteria:

• 9 to 65 years old healthy residents;

• volunteered for the experiment and signed informed consent;

• the subjects or their guardians can comply with the requirements of the clinical trial protocol;

• have not received rabies vaccination at any time;

• nearly six months has not been mammals bite, scratch;

• not participating in clinical trials of other drugs;

• No use of human immunoglobulin or other products in the past six months.

Exclusion Criteria:

First needle exclusion:

• have allergies, convulsions, seizures, mental and nervous system, such as history, or family history of epilepsy;

• Allergic to the main ingredient of the investigational vaccine;

• known to people with poor immune function damage or the tumor, spleen;

• Axillary temperature >38.0? within 7 days due to acute febrile illness;

• Patients with axillary body temperature > 37.0?;

• Severe chronic diseases such as congenital malformation, developmental disorder or severe cardiovascular disease, diabetes mellitus, hypertension that cannot be stabilized by drugs, liver and kidney diseases, and malignant tumors;

• patients with acute and chronic infectious diseases, active infections, severe asthma, infectious skin diseases;

• pregnant and lactating women; Any circumstances that the investigator believes may affect the assessment of the trial.

Subsequent needle exclusions:

• any serious adverse event causally related to vaccination;

• new findings that meet the "first dose exclusion criteria";

• the researchers think that may affect test evaluation of any situation.

Related Conditions & MeSH terms

• Rabies
• Rabies Human

Intervention

Biological:
• Control 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.
• Experimental vaccine
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.

Locations

Country	Name	City	State
China	Xia Shengli	Zhengzhou	Henan

Sponsors (2)

Lead Sponsor	Collaborator
Hualan Biological Bacterin Co. Ltd.	Henan Center for Disease Control and Prevention

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Every needle 30 days after vaccination
Primary	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	Vaccinations 31 days to 180 days
Primary	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	Every needle 30 days after vaccination
Primary	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	Vaccinations 31 days to 180 days
Secondary	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	5 agent group gathering subjects were 0, 7, 14, 42 days of blood samples
Secondary	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	Blood samples were collected on day 0, 7, 14 and 35 in the 4-dose group