Status:
COMPLETED
A Study to Evaluate Persistence of Immunity of PCV13 in Healthy Population Aged 2 Months，7 Months-5 Years
Lead Sponsor:
Beijing Minhai Biotechnology Co., Ltd
Conditions:
Pneumonia
Eligibility:
All Genders
2-5 years
Phase:
PHASE4
Brief Summary
The goal of this clinical trial is to learn about persistence of immunity of PCV13 in healthy population aged 2 months, 7 months-5 years. The main questions it aims to answer are the percentage of sub...
Eligibility Criteria
Inclusion
- Those who have participated in the Phase III clinical study of Beijing Minhai PCV13 and have been fully vaccinated with Minhai PCV13;
- An informed consent was required to sign by their legal guardians;
- Volunteers and their legal guardians/caregivers were able to attend the study visit as required by the protocol.
Exclusion
- Those who had any administration history of pneumococcal polysaccharide or conjugate vaccine after participating in the Phase III clinical study;
- Prior to enrollment, patients who had a history of pneumococcal infection with one or more of the well-defined PCV13 serotypes;
- The researchers shall judge the other conditions which might be not in compliance with the requirements of this clinical trial.
Key Trial Info
Start Date :
September 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 13 2022
Estimated Enrollment :
621 Patients enrolled
Trial Details
Trial ID
NCT06210737
Start Date
September 26 2019
End Date
November 13 2022
Last Update
January 18 2024
Active Locations (1)
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1
Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu, China, 210000