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Completed

NCT Number: NCT06210737

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

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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Key information

Conditions

Pneumonia Infections Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections

Age range

2 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Jiangsu Provincial Center for Diseases Control and Prevention

Nanjing, Jiangsu, 210000, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PCV13

Biological

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

Primary outcomes

  1. 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. 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.

  3. Serious Adverse Events (SAE)

    Time frame: one months to 12 months after the last injection

Sponsors and collaborators

Lead sponsor

Beijing Minhai Biotechnology Co., Ltd

Industry

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jan 18, 2024
Registry last updated
Jan 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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