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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

From the registry’s dates

  • Registered 4 years 3 months after the study started (first participant enrolled Sep 2019, registered Jan 2024).
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

In context

Pneumonia

1,564 studies on the registry are indexed under Pneumonia; 265 are open to participants now.

This study's enrollment of 621 is above the median of 129 across 975 interventional studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

Beijing Minhai Biotechnology Co., Ltd is the lead sponsor of 10 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

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

06

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

07

Study locations

1 site
  • Jiangsu Provincial Center for Diseases Control and Prevention
    Nanjing, Jiangsu 210000, China
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2019 to primary completion in Nov 2022, 37 months.

Of 49 phase 4 interventional studies under Pneumonia, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 40. This study's 37 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 8, 2024
First posted
Jan 18, 2024
StartActual
Sep 26, 2019
Primary completionActual
Nov 13, 2022
CompletionActual
Nov 13, 2022
Last update
Jan 18, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

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 ↗

Not currently enrolling

This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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