MedTrace Logo

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

NCT06210737 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 621

Last updated 2024-01-18

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Beijing Minhai Biotechnology Co., Ltd

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-26
Primary Completion
2022-11-13
Completion
2022-11-13

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06210737 on ClinicalTrials.gov