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

B

Beijing Minhai Biotechnology

Status and phase

Completed
Phase 4

Conditions

Pneumonia

Treatments

Biological: PCV13

Study type

Interventional

Funder types

Industry

Identifiers

NCT06210737
2014L00987-1

Details and patient eligibility

About

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.

Enrollment

621 patients

Sex

All

Ages

2 months to 5 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

621 participants in 4 patient groups

2 months group
Other group
Treatment:
Biological: PCV13
7-11 months group
Other group
Treatment:
Biological: PCV13
12-23 months group
Other group
Treatment:
Biological: PCV13
2-5 years old group
Other group
Treatment:
Biological: PCV13

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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