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

NCT06210737 | Completed Phase 4

• 1 other identifier: 2014L00987-1
• Study Type: interventional
• Target: 621
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pneumonia

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (4)

2 months group

OTHER

Biological: PCV13

7-11 months group

OTHER

Biological: PCV13

12-23 months group

OTHER

Biological: PCV13

2-5 years old group

OTHER

Biological: PCV13

Interventions

PCV13 BIOLOGICAL

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

2 months group

Eligibility Criteria

• Age: 2 Months - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Minhai Biotechnology Co., Ltd: lead

Study Sites (1)

Jiangsu Provincial Center for Diseases Control and Prevention

Nanjing, Jiangsu, 210000, China

Location

Related Publications (1)

• Li G, Ren T, Zhang H, Ti J, Chang X, Yin S, Guan Y, Liu G, Liang Q, Liu J. Persistence of immunity in children aged 2 months and 7 months - 5 years old after primary immunization with 13-valent pneumococcal conjugate vaccine. Vaccine. 2024 Oct 24;42(24):126209. doi: 10.1016/j.vaccine.2024.126209. Epub 2024 Aug 31.

  PMID: 39217777 DERIVED

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 18, 2024
• Study Start: September 26, 2019
• Primary Completion: November 13, 2022
• Study Completion: November 13, 2022
• Last Updated: January 18, 2024

Record last verified: 2024-01

Locations

CN (1)