PneumoniaPhase 4NCT06210737
A Study to Evaluate Persistence of Immunity of PCV13 in Healthy Population Aged 2 Months，7 Months-5 Years
A Phase 4 study testing PCV13 in people with Pneumonia, run by Beijing Minhai Biotechnology Co., Ltd at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 months to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Pneumonia
- What is being tested?
- PCV13
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 621 participants
- Where
- 1 siteChina
- Study dates
- 26 Sep 2019to 13 Nov 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu, 210000
About this study
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
- Being tested
- PCV13
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCV13Biological
3 doses of PCV13 intramuscularly at Months 0, 2, and 4 and a booster dose at Month 10
PCV13Biological
2 doses of PCV13, and a booster dose
PCV13Biological
2 doses of PCV13
PCV13Biological
single dose of PCV13
| Study group | Role | What they receive |
|---|---|---|
| 2 months group | Other | Not described Receives: Biological: PCV13 |
| 7-11 months group | Other | Not described Receives: Biological: PCV13 |
| 12-23 months group | Other | Not described Receives: Biological: PCV13 |
| 2-5 years old group | Other | Not described Receives: Biological: PCV13 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2-5 years after the first dose
Serious Adverse Events (SAE)
Measured: one months to 12 months after the last injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start26 Sep 2019
- Primary completion13 Nov 2022
- Study completion13 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 621 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Minhai Biotechnology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06210737
- Sponsor's protocol ID
- 2014L00987-1
- Status last verified
- Jan 2024
- First submitted
- 8 Jan 2024
- Last updated
- 18 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39217777
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate Persistence of Immunity of PCV13 in Healthy Population Aged 2 Months，7 Months-5 Years
- ClinicalTrials.gov ID
- NCT06210737
- Acronym / sponsor ID
- 2014L00987-1
- Conditions
- Pneumonia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 621 participants (actual)
- Lead sponsor
- Beijing Minhai Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 26 Sep 2019 (actual)
- Primary completion
- 13 Nov 2022 (actual)
- Study completion
- 13 Nov 2022 (actual)
- First posted
- 18 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 2 months to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCV133 doses of PCV13 intramuscularly at Months 0, 2, and 4 and a booster dose at Month 10 | Biological | 2 months group |
| PCV132 doses of PCV13, and a booster dose | Biological | 7-11 months group |
| PCV132 doses of PCV13 | Biological | 12-23 months group |
| PCV13single dose of PCV13 | Biological | 2-5 years old group |
Primary outcome
percentage of subjects reached the IgG level of ≥0.35 µg/mL
Time frame: 2-5 years after the first dose
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.
GMCs level for IgG antibody
Time frame: 2-5 years after the first dose
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.
Serious Adverse Events (SAE)
Time frame: one months to 12 months after the last injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Derived from this study: PubMed 39217777Li 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PCV13 in people with Pneumonia, run by Beijing Minhai Biotechnology Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of subjects reached the IgG level of ≥0.35 µg/mL (time frame: 2-5 years after the first dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06210737, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.