Pneumococcal InfectionsPhase 4NCT05731115
Lot-to-lot Consistency of 23-valent Pneumococcal Polysaccharide Vaccine
A Phase 4 study testing Experimental 23-valent Pneumococcal in people with Pneumococcal Infections, run by Sinovac Biotech Co., Ltd at 2 sites in China.
Trial summary
This study is a randomized, double-blind phase Ⅳ clinical trial of 23-valent pneumococcal polysaccharide vaccine manufactured by Sinovac Biotech Co., Ltd.The purpose of this study is to evaluate the consistency of three consecutive lots, immunogenicity and safety of 23-valent pneumococcal polysaccharide vaccine of… Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Infections
- What is being tested?
- Experimental 23-valent Pneumococcal
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,800 participants
- Where
- 2 sitesChina
- Study dates
- 27 Feb 2023to 5 May 2023
- 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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 40-65 years in stable health;
- The subjects can understand and voluntarily sign the informed consent form;
- Proven legal identity.
Who cannot join
- Have received any pneumococcal vaccine;
- History bacterial pneumonia or invasive pneumococcal infectious diseases caused by pneumococci and confirmed by culture;
- Women of childbearing age (menarche to premenopause) are pregnant (including positive urine pregnancy test), breastfeeding or planning pregnancy within 1 month;
- History of asthma, allergy to vaccines or vaccine components, and serious adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema;
- Severe chronic diseases,such as severe cardiovascular diseases, hypertension(Systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg) and diabetes that cannot be controlled by drugs, liver or kidney diseases,malignant tumors, etc.;
- Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
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- Autoimmune disease or immune deficiency/immunosuppression;
- Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation;
- Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids(excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months;
- A long history of alcohol or drug abuse;
- Receipt of blood products within in the past 3 months;
- Receipt of other investigational drugs within 30 days prior to receiving the investigational vaccine;
- Receipt of attenuated live vaccines or COVID-19 vaccines in the past 14 days;
- Receipt of inactivated or subunit vaccines in the past 7 days;
- Onset of various acute or chronic diseases within 7 days prior to the study;
- Underarm body temperature before vaccination>37.0°C;
- The subjects participated in other clinical trials during the follow-up period or will be planned to participate other clinical trials within 1 months;
- According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
Trial locations and contacts
2 sites in 1 country.
China2 sites
The First People's Hospital of Yuanping Medical Group
Yuanping, Shanxi, 034199
Salt Lake District Center for Disease Control and Prevention
Yuncheng, Shanxi, 044000
About this study
Official title: A Randomized, Double-blind Clinical Trial to Evaluate the Lot Consistency, Immunogenicity and Safety of 23-valent Pneumococcal Polysaccharide Vaccine in Adults Aged 40-65 Years
This study is a randomized, double-blind phase Ⅳ clinical trial of 23-valent pneumococcal polysaccharide vaccine manufactured by Sinovac Biotech Co., Ltd.The purpose of this study is to evaluate the consistency of three consecutive lots, immunogenicity and safety of 23-valent pneumococcal polysaccharide vaccine of commercial scale in participants aged 40-65 years.
Read the detailed description
This study is a randomized, double-blind phase Ⅳ clinical trial in subjects aged 40-65 years to evaluate the lot-to-lot consistency,immunogenicity and safety of 23-valent pneumococcal polysaccharide vaccine of commercial scale.The experimental vaccine was manufactured by Sinovac Biotech Co., Ltd.A total of 1800 subjects will be enrolled.The subjects will be randomly divided into three groups in a ratio of 1:1:1 to received one dose of vaccine on day 0.
- Conditions
- Pneumococcal Infections
- Being tested
- Experimental 23-valent Pneumococcal
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental 23-valent PneumococcalBiological
The investigational vaccine was manufactured by Sinovac Biotech Co., Ltd.25μg each for serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B,17F,18C, 19A, 19F, 20, 22F, 23F, and 33F in 0.5 mL of sodium chloride mixture per injection.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Vaccine-lot 1 | Experimental | Participants (n=600) aged 40-65 years will receive one dose of 23-valent pneumococcal polysaccharide vaccine of commercial scale production lot 1. Receives: Biological: Experimental 23-valent Pneumococcal |
| Experimental Vaccine-lot 2 | Experimental | Participants (n=600) aged 40-65 years will receive one dose of 23-valent pneumococcal polysaccharide vaccine of commercial scale production lot 2. Receives: Biological: Experimental 23-valent Pneumococcal |
| Experimental Vaccine-lot 3 | Experimental | Participants (n=600) aged 40-65 years will receive one dose of 23-valent pneumococcal polysaccharide vaccine of commercial scale production lot 3. Receives: Biological: Experimental 23-valent Pneumococcal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity index-Geometric Mean Concentration (GMC)
GMC for serotype-specific pneumococcal immunoglobulin G (IgG) antibody 30 days after vaccination.
Measured: 30 days after vaccination
Secondary outcomes (5)
Immunogenicity index-Geometric Mean Increase (GMI)
GMI for serotype-specific pneumococcal IgG antibody 30 days after vaccination.
Measured: 30 days after vaccination
Immunogenicity index-Seroconversion rate (2-fold increase rate)
Seroconversion rate (2-fold increase rate) for serotype-specific pneumococcal IgG antibody 30 days after vaccination.
Measured: 30 days after vaccination
Safety index-Incidence of adverse reactions
Incidence of adverse reactions within 30 days after vaccination
Measured: Within 30 days after vaccination
Safety index-Incidence of adverse reactions
Incidence of adverse reactions within 7 days after vaccination
Measured: Within 7 days after vaccination
Safety index-Incidence of serious adverse events
Incidence of serious adverse events within 30 days after vaccination.
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 posted16 Feb 2023
- Study start27 Feb 2023
- Primary completion5 May 2023
- Study completion5 May 2023
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 Pneumococcal InfectionsStudies of the same condition, open and under way.
- More trials run by Sinovac Biotech Co., LtdThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinovac Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yunong Zhang, Principal investigator, Shanxi Provincial Center for Disease Prevention and Control
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05731115
- Sponsor's protocol ID
- PRO-PPV-4003
- Status last verified
- Feb 2023
- First submitted
- 7 Feb 2023
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang Y, Shi G, Zhou S, Zhao W, Wang L, Li J, Zhao Z, Li G, Geng J, Chen Z, Zhao H, Li Y, Xu L, Wang B, Jiao P, Li G. Lot-to-lot consistency, immunogenicity, and safety of a 23-valent pneumococcal polysaccharide vaccine (PPV23) in healthy adults aged 40-65 years: A randomized, double-blind, controlled, phase IV clinical trial. Hum Vaccin Immunother. 2025 Dec;21(1):2579366. doi: 10.1080/21645515.2025.2579366. Epub 2025 Oct 30.
PubMed 41165164
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind Clinical Trial to Evaluate the Lot Consistency, Immunogenicity and Safety of 23-valent Pneumococcal Polysaccharide Vaccine in Adults Aged 40-65 Years
- ClinicalTrials.gov ID
- NCT05731115
- Acronym / sponsor ID
- PRO-PPV-4003
- Conditions
- Pneumococcal Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,800 participants (actual)
- Lead sponsor
- Sinovac Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 5 May 2023 (actual)
- Study completion
- 5 May 2023 (actual)
- First posted
- 16 Feb 2023 (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.
This study is a randomized, double-blind phase Ⅳ clinical trial of 23-valent pneumococcal polysaccharide vaccine manufactured by Sinovac Biotech Co., Ltd.The purpose of this study is to evaluate the consistency of three consecutive lots, immunogenicity and safety of 23-valent pneumococcal polysaccharide vaccine of commercial scale in participants aged 40-65 years.
Detailed description
This study is a randomized, double-blind phase Ⅳ clinical trial in subjects aged 40-65 years to evaluate the lot-to-lot consistency,immunogenicity and safety of 23-valent pneumococcal polysaccharide vaccine of commercial scale.The experimental vaccine was manufactured by Sinovac Biotech Co., Ltd.A total of 1800 subjects will be enrolled.The subjects will be randomly divided into three groups in a ratio of 1:1:1 to received one dose of vaccine on day 0.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental Vaccine-lot 1 | Experimental | Biological: Experimental 23-valent PneumococcalParticipants (n=600) aged 40-65 years will receive one dose of 23-valent pneumococcal polysaccharide vaccine of commercial scale production lot 1. |
| Experimental Vaccine-lot 2 | Experimental | Biological: Experimental 23-valent PneumococcalParticipants (n=600) aged 40-65 years will receive one dose of 23-valent pneumococcal polysaccharide vaccine of commercial scale production lot 2. |
| Experimental Vaccine-lot 3 | Experimental | Biological: Experimental 23-valent PneumococcalParticipants (n=600) aged 40-65 years will receive one dose of 23-valent pneumococcal polysaccharide vaccine of commercial scale production lot 3. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 40-65 years in stable health;
- The subjects can understand and voluntarily sign the informed consent form;
- Proven legal identity.
Key exclusion criteria (18 listed)
- Have received any pneumococcal vaccine;
- History bacterial pneumonia or invasive pneumococcal infectious diseases caused by pneumococci and confirmed by culture;
- Women of childbearing age (menarche to premenopause) are pregnant (including positive urine pregnancy test), breastfeeding or planning pregnancy within 1 month;
- History of asthma, allergy to vaccines or vaccine components, and serious adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema;
- Severe chronic diseases,such as severe cardiovascular diseases, hypertension(Systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg) and diabetes that cannot be controlled by drugs, liver or kidney diseases,malignant tumors, etc.;
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 |
|---|---|---|
| Experimental 23-valent PneumococcalThe investigational vaccine was manufactured by Sinovac Biotech Co., Ltd.25μg each for serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B,17F,18C, 19A, 19F, 20, 22F, 23F, and 33F in 0.5 mL of sodium chloride mixture per injection. | Biological | Experimental Vaccine-lot 1, Experimental Vaccine-lot 2, Experimental Vaccine-lot 3 |
Primary outcome
Immunogenicity index-Geometric Mean Concentration (GMC)
Time frame: 30 days after vaccination
GMC for serotype-specific pneumococcal immunoglobulin G (IgG) antibody 30 days after vaccination.
5 secondary outcomes
Immunogenicity index-Geometric Mean Increase (GMI)
Time frame: 30 days after vaccination
Immunogenicity index-Seroconversion rate (2-fold increase rate)
Time frame: 30 days after vaccination
Safety index-Incidence of adverse reactions
Time frame: Within 30 days after vaccination
Safety index-Incidence of adverse reactions
Time frame: Within 7 days after vaccination
Safety index-Incidence of serious adverse events
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 18 Sep 2023.
- Derived from this study: PubMed 41165164Zhang Y, Shi G, Zhou S, Zhao W, Wang L, Li J, Zhao Z, Li G, Geng J, Chen Z, Zhao H, Li Y, Xu L, Wang B, Jiao P, Li G. Lot-to-lot consistency, immunogenicity, and safety of a 23-valent pneumococcal polysaccharide vaccine (PPV23) in healthy adults aged 40-65 years: A randomized, double-blind, controlled, phase IV clinical trial. Hum Vaccin Immunother. 2025 Dec;21(1):2579366. doi: 10.1080/21645515.2025.2579366. Epub 2025 Oct 30.
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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.
Yunong Zhang principal investigator
Shanxi Provincial Center for Disease Prevention and Control
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Experimental 23-valent Pneumococcal in people with Pneumococcal Infections, run by Sinovac Biotech Co., Ltd at 2 sites 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 18 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 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Immunogenicity index-Geometric Mean Concentration (GMC) (time frame: 30 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 NCT05731115, 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 Sep 2023.