Immunogenic response of different antigenic values: investigation of intradermal purified Vero cell rabies vaccine in healthy volunteers

Phase 2

• Conditions: Immunogenic response of different antigenic valuesintradermal purified Vero cell rabies vaccine; immunogenic response; different antigenic values; rabies vaccine; healthy volunteer; intradermal; purified Vero cell rabies vaccine

• Registration Number: TCTR20190314002
• Lead Sponsor: BIOGENETECH CO.,LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-14
• Study Completion: 2021-06-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Healthy volunteers Male or female, age 18 years or over, but not more than 50 years old
2. Ability to read and sign the patient information sheet and inform consent form

Exclusion Criteria

1. Refuse to sign the patient information sheet and inform consent form.
2. Being a volunteer in another clinical research or having participated in other investigational product research within 4 weeks before entering a clinical trial or being in the equivalent period of 5 times the half-life for another investigational product.
3. Administration of full course of vaccine or at least 3 shots of rabies vaccine before or after contacting the disease.
4. Have a history of allergy to vaccine components in this study.
5. Used to receive serum from horses (such as antiseptic serum, tetanus, serum, rabies, diphtheria, etc.)
6. Have serious illnesses that are dangerous or may cause a risk of participating in a clinical trial.
7. Acquiring Corticosteroids, chloroquine or immunosuppressants or having a history of immunodeficiency.
8. History of drug addiction or alcoholism.
9. Pregnant or breastfeeding females.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Immunogenic response of different antigenic values 180 days after administration STATA, One-way ANOVA and two-sample independent t-test

Secondary Outcome Measures

Name	Time	Method
Side effect of rabies vaccines in subjects who received different antigenic values Throughout the period of the study STATA, One-way ANOVA and two-sample independent t-test