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

January 8, 2024 updated by: Beijing Minhai Biotechnology Co., Ltd
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

621

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Jiangsu Provincial Center for Diseases Control and Prevention

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 2 months group
Biological: PCV13
3 doses of PCV13 intramuscularly at Months 0, 2, and 4 and a booster dose at Month 10
Biological: PCV13
2 doses of PCV13, and a booster dose
Biological: PCV13
2 doses of PCV13
Biological: PCV13
single dose of PCV13
Other: 7-11 months group
Biological: PCV13
3 doses of PCV13 intramuscularly at Months 0, 2, and 4 and a booster dose at Month 10
Biological: PCV13
2 doses of PCV13, and a booster dose
Biological: PCV13
2 doses of PCV13
Biological: PCV13
single dose of PCV13
Other: 12-23 months group
Biological: PCV13
3 doses of PCV13 intramuscularly at Months 0, 2, and 4 and a booster dose at Month 10
Biological: PCV13
2 doses of PCV13, and a booster dose
Biological: PCV13
2 doses of PCV13
Biological: PCV13
single dose of PCV13
Other: 2-5 years old group
Biological: PCV13
3 doses of PCV13 intramuscularly at Months 0, 2, and 4 and a booster dose at Month 10
Biological: PCV13
2 doses of PCV13, and a booster dose
Biological: PCV13
2 doses of PCV13
Biological: PCV13
single dose of PCV13

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
percentage of subjects reached the IgG level of ≥0.35 µg/mL
Time Frame: 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.
2-5 years after the first dose
GMCs level for IgG antibody
Time Frame: 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.
2-5 years after the first dose
Serious Adverse Events (SAE)
Time Frame: one months to 12 months after the last injection
one months to 12 months after the last injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Minhai Biotechnology Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 2019

Primary Completion (Actual)

November 13, 2022

Study Completion (Actual)

November 13, 2022

Study Registration Dates

First Submitted

January 8, 2024

First Submitted That Met QC Criteria

January 8, 2024

First Posted (Estimated)

January 18, 2024

Study Record Updates

Last Update Posted (Estimated)

January 18, 2024

Last Update Submitted That Met QC Criteria

January 8, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014L00987-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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