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

Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06210737
• Other study ID #: 2014L00987-1
• Status: Completed
• Phase: Phase 4
• Start date: September 26, 2019
• Est. completion date: November 13, 2022

Study information

• Verified date: January 2024
• Source: Beijing Minhai Biotechnology Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 621
• Est. completion date: November 13, 2022
• Est. primary completion date: November 13, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Months to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pneumonia

Intervention

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

Locations

Country	Name	City	State
China	Jiangsu Provincial Center for Diseases Control and Prevention	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Minhai Biotechnology Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Serious Adverse Events (SAE)		one months to 12 months after the last injection