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.

Study Overview

• Status: Completed
• Conditions: Pneumonia
• Intervention / Treatment: Biological: PCV13; Biological: PCV13; Biological: PCV13; Biological: PCV13

• Study Type: Interventional
• Enrollment (Actual): 621
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

4

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	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	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)		one months to 12 months after the last injection

Collaborators and Investigators

• Sponsor: Beijing Minhai Biotechnology Co., Ltd

Study record dates

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: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia
• 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