A Study to Evaluate Persistence of Immunity of PCV13 in Healthy Population Aged 2 Months，7 Months-5 Years

Beijing Minhai Biotechnology

Status and phase: Completed; Phase 4

Conditions: Pneumonia

Treatments: Biological: PCV13

Study type: Interventional

Funder types: Industry

Identifiers

NCT06210737

2014L00987-1

Details and patient eligibility

About

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.

Enrollment: 621 patients

Sex: All

Ages: 2 months to 5 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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621 participants in 4 patient groups

2 months group

Other group

Treatment:

Biological: PCV13

Biological: PCV13

Biological: PCV13

Biological: PCV13

7-11 months group

Other group

Treatment:

Biological: PCV13

Biological: PCV13

Biological: PCV13

Biological: PCV13

12-23 months group

Other group

Treatment:

Biological: PCV13

Biological: PCV13

Biological: PCV13

Biological: PCV13

2-5 years old group

Other group

Treatment:

Biological: PCV13

Biological: PCV13

Biological: PCV13

Biological: PCV13