Pneumonia
Conditions
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.
Interventions
BIOLOGICALPCV13
3 doses of PCV13 intramuscularly at Months 0, 2, and 4 and a booster dose at Month 10
Sponsors
Beijing Minhai Biotechnology Co., Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Months to 5 Years
Healthy volunteers
Yes
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Serious Adverse Events (SAE) | one months to 12 months after the last injection | — |
Countries
China
Outcome results
None listed