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CompletedNCT06210737Updated Jan 18, 2024

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

A Phase 4 interventional study of PCV13 and PCV13 in Pneumonia, sponsored by Beijing Minhai Biotechnology Co., Ltd. Completed at 1 site in China. Open to participants aged 2 Months to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-18.

Sponsored by Beijing Minhai Biotechnology Co., Ltd · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
621
Allocation
Non-randomized
Ages
2 Months to 5 Years
Sex
All
01

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.

02

Conditions studied

  • Pneumonia

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03

Who can participate

Ages eligible
2 Months to 5 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
621 participants (actual)

Study arms

  • Other
    2 months group

    Biological: PCV13

  • Other
    7-11 months group

    Biological: PCV13

  • Other
    12-23 months group

    Biological: PCV13

  • Other
    2-5 years old group

    Biological: PCV13

Interventions

  • BiologicalPCV13

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

  • BiologicalPCV13

    2 doses of PCV13, and a booster dose

  • BiologicalPCV13

    2 doses of PCV13

  • BiologicalPCV13

    single dose of PCV13

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2-5 years after the first dose

  2. 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.

    Time frame: 2-5 years after the first dose

  3. Serious Adverse Events (SAE)

    Time frame: one months to 12 months after the last injection

06

Study locations

1 site
  • Jiangsu Provincial Center for Diseases Control and Prevention
    Nanjing, Jiangsu 210000, China
07

Registry details

Key details

Study ID
NCT06210737
Lead sponsor
Beijing Minhai Biotechnology Co., Ltd
Responsible party
Sponsor
First posted
Jan 18, 2024
Start date
Sep 26, 2019
Primary completion
Nov 13, 2022
Completion
Nov 13, 2022
Last update
Jan 18, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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