Observation on the Immune Persistence of People Aged 10-60 Years Old Immunized With Five Doses of Rabies Vaccine
Single Arm, Single Center Phase IV Clinical Trial to Evaluate the Immune Persistence and Safety of Freeze-dried Human Rabies Vaccine (Vero Cell)
1 other identifier
interventional
149
1 country
1
Brief Summary
Evaluation of immune persistence after rabies vaccination in 150 people.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Nov 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 17, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 8, 2021
CompletedFirst Submitted
Initial submission to the registry
September 13, 2022
CompletedFirst Posted
Study publicly available on registry
September 21, 2022
CompletedSeptember 21, 2022
September 1, 2022
1.1 years
September 13, 2022
September 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
positive conversion rate evaluation (6 months)
Evaluate the positive conversion rate 6 months after vaccination of rabies vaccine according to the 5-dose immunization program
6 months
antibody titer evaluation (6 months)
Evaluate the antibody titer of serum neutralizing antibody 6 months after vaccination of rabies vaccine according to the 5-dose immunization program
6 months
positive conversion rate evaluation (12 months)
Evaluate the positive conversion rate 12 months after vaccination of rabies vaccine according to the 5-dose immunization program
12 months
antibody titer evaluation (12 months)
Evaluate the antibody titer of serum neutralizing antibody 12 months after vaccination of rabies vaccine according to the 5-dose immunization program
12 months
Study Arms (1)
experimental arm
EXPERIMENTAL5 doses of rabies vaccine
Interventions
Inoculate 5 doses of rabies vaccine, and collect blood at fixed time points to detect neutralizing antibody
Eligibility Criteria
You may qualify if:
- years old；
- Temperature on the day of admission≤37.0 ° C (axillary temperature).
You may not qualify if:
- Have a history of rabies vaccine immunization or use of rabies virus passive immunization agents；
- Has been diagnosed with congenital or acquired immunodeficiency disease;
- Pregnancy (including positive urine pregnancy test) or lactation, planned pregnancy preparation within 2 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Changchun Zhuoyi Biological Co., Ltd
Changchun, Jilin, 130000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Li Miao, Dr
Changchun Zhuoyi Biological Co., Ltd
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2022
First Posted
September 21, 2022
Study Start
November 11, 2019
Primary Completion
December 17, 2020
Study Completion
November 8, 2021
Last Updated
September 21, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, CSR
- Time Frame
- before December 2022.
- Access Criteria
- public for all.
all data of antibody titer .