VaccinationPhase 4NCT04701788
A Clinical Trial to Evaluate the Immunogenicity and Safety of PPV23 Vaccine Revaccinations in the Elderly
A Phase 4 study testing 23-valent pneumococcal polysaccharide vaccine in people with Vaccination, run by China National Biotec Group Company Limited at 1 site in China.
Trial summary
To evaluate the the immunogenicity and safety of 23-valent pneumococcal polysaccharide vaccine revaccinations in the elderly Read more about this study
- Who is it for?
- Ages 60 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaccination
- What is being tested?
- 23-valent pneumococcal polysaccharide vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 331 participants
- Where
- 1 siteChina
- Study dates
- 30 Mar 2021to 15 Feb 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 60 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1.The age was 60-65 years old on the day of enrollment;2.The subjects have signed the informed consent and signed the date;3.The subjects are able to participate in all planned follow-up visits and were able to follow all trial procedures (e.g. complete diary card / contact card, return to visit);4.The subjects in the study group had been vaccinated with 23 valent pneumococcal polysaccharide vaccine made in China for more than 5 years; 5.The control group had never been vaccinated with any pneumococcal vaccine; 6.Axillary temperature ≤37.0℃.
Who cannot join
- 1.With a medical history with hypersensitiveness, eclampsia, epilepsy, cerebropathia and neurological illness; 2.Allergic to any ingredient of vaccine or with allergy history to any vaccine; 3.Subjects with immunodeficency or suspected impairment of immunologic function (e.g. caused by HIV), or subjects are in the process of immunosuppressor therapy(Taking orally injecting of steroid hormone); 4.Administration of immunoglobulins within 30 days prior to this study; 5.Acute febrile disease(temperature ≥ 37.0°C) or infectious disease; 6.With a clearly diagnosed history of thrombocytopenia or other coagulopathy, may cause contraindications for subcutaneous injection; 7.With any serious chronic illness, acute infectious diseases, or respiratory diseases; 8.Suffering from serious cardiovascular diseases (pulmonary heart disease, pulmonary edema, hypertension can not be controlled to normal by drugs), liver and kidney diseases, diabetes with complications;9.With any kind of infectious, purulent, or allergic skin diseases; 10.With any other factor that makes the investigator determines the subject is unsuitable for this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Sichuan Center for Disease Control and Prevention
Chengdu, Sichuan, 610041
About this study
Official title: A Phase Ⅳ Clinical Trial to Evaluate the Immunogenicity and Safety of 23-valent Pneumococcal Polysaccharide Vaccine Revaccinations in the Elderly
To evaluate the the immunogenicity and safety of 23-valent pneumococcal polysaccharide vaccine revaccinations in the elderly
Read the detailed description
- Antibody double growth rate in 28-40 days after immunization;
- Antibody GMC level in 28-40days after immunization;
- Incidence of adverse reactions in 0-30days.
- Conditions
- Vaccination
- Being tested
- 23-valent pneumococcal polysaccharide vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
23-valent pneumococcal polysaccharide vaccineBiological
The study group and the control group were injected with a dose of 23-valent pneumococcal polysaccharide vaccine. One month later, blood was collected and serum was separated.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | The subjects in the study group had been vaccinated with 23 valent pneumococcal polysaccharide vaccine made in China for more than 5 years. Receives: Biological: 23-valent pneumococcal polysaccharide vaccine |
| Control group | Placebo comparator | The control group had never been vaccinated with any pneumococcal vaccine. Receives: Biological: 23-valent pneumococcal polysaccharide vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-fold growth rate of antibody
The serum antibody level of pneumococci was determined by modified enzyme-linked immunosorbent assay. The double growth rate of serum antibody level was calculated.
Measured: The blood collection time was 28-40 days after vaccination.
Secondary outcomes (2)
Antibody GMC level
The serum antibody level of pneumococci was determined by modified enzyme-linked immunosorbent assay.
Measured: The blood collection time was 28-40 days after vaccination.
Incidence of adverse reactions
Adverse reactions were collected during the observation period.
Measured: Within 30 days after vaccination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start30 Mar 2021
- Primary completion20 Dec 2021
- Study completion15 Feb 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 VaccinationStudies 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
- Model description
- Study group is PPV23 revaccination and control group PPV23-vaccination.
- Masking
- None (open label)
- Enrolment
- 331 participants (actual)
Sponsor and investigators
- Lead sponsor
- China National Biotec Group Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sichuan Center for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Qianli Ma, Study director, Sichuan Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04701788
- Sponsor's protocol ID
- PPV23-2021-1
- Status last verified
- Feb 2022
- First submitted
- 6 Jan 2021
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Qiu J, Li Z, Huang F, Huang Z, Liang X, Li J, Liao Y, Guo X, Sun X. Immunogenicity and safety study of 23-valent pneumococcal polysaccharide vaccine revaccination among elderly individuals aged 60-70 years in Shanghai, China. Front Immunol. 2025 Jul 17;16:1623611. doi: 10.3389/fimmu.2025.1623611. eCollection 2025.
PubMed 40746543
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅳ Clinical Trial to Evaluate the Immunogenicity and Safety of 23-valent Pneumococcal Polysaccharide Vaccine Revaccinations in the Elderly
- ClinicalTrials.gov ID
- NCT04701788
- Acronym / sponsor ID
- PPV23-2021-1
- Conditions
- Vaccination
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 331 participants (actual)
- Lead sponsor
- China National Biotec Group Company LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Sichuan Center for Disease Control and Prevention
- Study start
- 30 Mar 2021 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 15 Feb 2022 (actual)
- First posted
- 8 Jan 2021 (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.
To evaluate the the immunogenicity and safety of 23-valent pneumococcal polysaccharide vaccine revaccinations in the elderly
Detailed description
- Antibody double growth rate in 28-40 days after immunization;
- Antibody GMC level in 28-40days after immunization;
- Incidence of adverse reactions in 0-30days.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Study group is PPV23 revaccination and control group PPV23-vaccination.
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Biological: 23-valent pneumococcal polysaccharide vaccineThe subjects in the study group had been vaccinated with 23 valent pneumococcal polysaccharide vaccine made in China for more than 5 years. |
| Control group | Placebo comparator | Biological: 23-valent pneumococcal polysaccharide vaccineThe control group had never been vaccinated with any pneumococcal vaccine. |
Who may qualify
- Ages
- 60 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1.The age was 60-65 years old on the day of enrollment;2.The subjects have signed the informed consent and signed the date;3.The subjects are able to participate in all planned follow-up visits and were able to follow all trial procedures (e.g. complete diary card / contact card, return to visit);4.The subjects in the study group had been vaccinated with 23 valent pneumococcal polysaccharide vaccine made in China for more than 5 years; 5.The control group had never been vaccinated with any pneumococcal vaccine; 6.Axillary temperature ≤37.0℃.
Key exclusion criteria (1 listed)
- 1.With a medical history with hypersensitiveness, eclampsia, epilepsy, cerebropathia and neurological illness; 2.Allergic to any ingredient of vaccine or with allergy history to any vaccine; 3.Subjects with immunodeficency or suspected impairment of immunologic function (e.g. caused by HIV), or subjects are in the process of immunosuppressor therapy(Taking orally injecting of steroid hormone); 4.Administration of immunoglobulins within 30 days prior to this study; 5.Acute febrile disease(temperature ≥ 37.0°C) or infectious disease; 6.With a clearly diagnosed history of thrombocytopenia or other coagulopathy, may cause contraindications for subcutaneous injection; 7.With any serious chronic illness, acute infectious diseases, or respiratory diseases; 8.Suffering from serious cardiovascular diseases (pulmonary heart disease, pulmonary edema, hypertension can not be controlled to normal by drugs), liver and kidney diseases, diabetes with complications;9.With any kind of infectious, purulent, or allergic skin diseases; 10.With any other factor that makes the investigator determines the subject is unsuitable for this study.
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 |
|---|---|---|
| 23-valent pneumococcal polysaccharide vaccineThe study group and the control group were injected with a dose of 23-valent pneumococcal polysaccharide vaccine. One month later, blood was collected and serum was separated. | Biological | Control group, Study group |
Primary outcome
2-fold growth rate of antibody
Time frame: The blood collection time was 28-40 days after vaccination.
The serum antibody level of pneumococci was determined by modified enzyme-linked immunosorbent assay. The double growth rate of serum antibody level was calculated.
2 secondary outcomes
Antibody GMC level
Time frame: The blood collection time was 28-40 days after vaccination.
Incidence of adverse reactions
Time frame: Within 30 days after vaccination.
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 16 Feb 2022.
- Derived from this study: PubMed 40746543Qiu J, Li Z, Huang F, Huang Z, Liang X, Li J, Liao Y, Guo X, Sun X. Immunogenicity and safety study of 23-valent pneumococcal polysaccharide vaccine revaccination among elderly individuals aged 60-70 years in Shanghai, China. Front Immunol. 2025 Jul 17;16:1623611. doi: 10.3389/fimmu.2025.1623611. eCollection 2025.
- Individual participant dataSharing planned: No
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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.
Qianli Ma study director
Sichuan Center for Disease Control and Prevention
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 23-valent pneumococcal polysaccharide vaccine in people with Vaccination, run by China National Biotec Group Company Limited 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 1 inclusion and 1 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 16 Feb 2022. 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. Some participants in this study may receive a placebo. 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?
2-fold growth rate of antibody (time frame: The blood collection time was 28-40 days after vaccination.). 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 NCT04701788, 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 16 Feb 2022.