A Study to Evaluate Persistence of Immunity of PCV13 in Healthy Population Aged 2 Months，7 Months-5 Years
- Conditions
- Pneumonia
- Interventions
- Biological: PCV13
- Registration Number
- NCT06210737
- Lead Sponsor
- Beijing Minhai Biotechnology Co., Ltd
- 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 subjects reached the IgG level of ≥0.35 µg/mL, GMCs level for IgG antibody, and SAEs from one month to 12 months after the last injection.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 621
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 months group PCV13 - 12-23 months group PCV13 - 2-5 years old group PCV13 - 7-11 months group PCV13 -
- Primary Outcome Measures
Name Time Method Serious Adverse Events (SAE) one months to 12 months after the last injection percentage of subjects reached the IgG level of ≥0.35 µg/mL 2-5 years after the first dose evaluation time: two years after the first dose for 2-5 years old group, two and three years after the first dose for 12-23 months group, two, three and four years after the first dose for 7-11 months group, two, three, four and five years after the first dose for 2 months group.
GMCs level for IgG antibody 2-5 years after the first dose evaluation time: two years after the first dose for 2-5 years old group, two and three years after the first dose for 12-23 months group, two, three and four years after the first dose for 7-11 months group, two, three, four and five years after the first dose for 2 months group.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Jiangsu Provincial Center for Diseases Control and Prevention
🇨🇳Nanjing, Jiangsu, China