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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

621 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-26

Study Completion Date

2022-11-13

Brief Summary

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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.

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Detailed Description

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Conditions

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Pneumonia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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2 months group

Group Type OTHER

PCV13

Intervention Type BIOLOGICAL

3 doses of PCV13 intramuscularly at Months 0, 2, and 4 and a booster dose at Month 10

7-11 months group

Group Type OTHER

PCV13

Intervention Type BIOLOGICAL

2 doses of PCV13, and a booster dose

12-23 months group

Group Type OTHER

PCV13

Intervention Type BIOLOGICAL

2 doses of PCV13

2-5 years old group

Group Type OTHER

PCV13

Intervention Type BIOLOGICAL

single dose of PCV13

Interventions

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PCV13

3 doses of PCV13 intramuscularly at Months 0, 2, and 4 and a booster dose at Month 10

Intervention Type BIOLOGICAL

PCV13

2 doses of PCV13, and a booster dose

Intervention Type BIOLOGICAL

PCV13

2 doses of PCV13

Intervention Type BIOLOGICAL

PCV13

single dose of PCV13

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

2 Months

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes