Pneumococcal Infectious DiseaseNCT07071701
A Clinical Trial to Observe the Safety of 23-Valent Pneumococcal Polysaccharide Vaccine in Target Population
An observational study of Pneumococcal Infectious Disease, run by Sinovac Biotech Co., Ltd at 1 site in China.
Trial summary
An open clinical trial of a 23-valent pneumococcal polysaccharide vaccine (PPV23) developed by Sinovac Life Science Co., Ltd was conducted to evaluate the safety of Sinovac PPV23 in target population of individuals aged 2 years and above. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Infectious Disease
- What is being tested?
- 23-valent pneumococcal polysaccharide vaccine and Influenza vaccine
- Type of treatment
- Vaccines
- How many people
- 19,267 participants
- Where
- 1 siteChina
- Study dates
- 2 Jul 2022to 5 Apr 2024
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants aged 2 years old and above.
Who may be able to join
- Have voluntarily and at their own expense received the 23-valent pneumococcal polysaccharide vaccine;
- Participants and/or their guardians are able to understand and voluntarily participate in this study and sign an informed consent form;
- Provide valid legal identification.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site
Jiangsu Provincial Center for Disease Prevention and Control
Nanjing, Jiangsu
About this study
Official title: A Clinical Trial to Observe the Safety of 23-Valent Pneumococcal Polysaccharide Vaccine in Target Population Aged 2 Years and Above
An open clinical trial of a 23-valent pneumococcal polysaccharide vaccine (PPV23) developed by Sinovac Life Science Co., Ltd was conducted to evaluate the safety of Sinovac PPV23 in target population of individuals aged 2 years and above. All participants received 1 dose of PPV23 and self-selected whether to receive 1 dose of influenza vaccine at the same time.
- Conditions
- Pneumococcal Infectious Disease
- Being tested
- 23-valent pneumococcal polysaccharide vaccine, Influenza vaccine
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
23-valent pneumococcal polysaccharide vaccineBiological
23-valent pneumococcal polysaccharide vaccine
Influenza vaccineBiological
Influenza vaccine
| Study group | Role | What they receive |
|---|---|---|
| Acitive safety surveillance group | Not described Receives: Biological: 23-valent pneumococcal polysaccharide vaccine; Biological: Influenza vaccine | |
| Passive safety surveillance group | Not described Receives: Biological: 23-valent pneumococcal polysaccharide vaccine; Biological: Influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse reactions to 23-valent pneumonia vaccine within 0-28 days after single and combined vaccination.
Measured: 28 days after the vaccination
Secondary outcomes (2)
Incidence of adverse events to 23-valent pneumonia vaccine within 0-28 days after single and combined vaccination.
Measured: 28 days after the vaccination
Incidence of adverse events to 23-valent pneumonia vaccine within 0-7 days after single and combined vaccination.
Measured: 7 days after the vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start2 Jul 2022
- Primary completion5 Apr 2024
- Study completion5 Apr 2024
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 Infectious DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19,267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinovac Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07071701
- Sponsor's protocol ID
- PRO-PPV-MA4002-JS
- Status last verified
- Jul 2025
- First submitted
- 8 Jul 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shi YF, Ju LH, Wang KN, Pan Y, Zou YY, Lu X, Tuo L, Zou WT, Wei MW, Zhao YW, Pan HX. Post-marketing Safety Surveillance of 23-Valent Pneumococcal Polysaccharide Vaccine Administered Alone and Concomitantly with Influenza Vaccine in Individuals Aged 2 Years and Older in China. Infect Dis Ther. 2026 Apr;15(4):1035-1046. doi: 10.1007/s40121-026-01309-4. Epub 2026 Feb 23.
PubMed 41729368
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Observe the Safety of 23-Valent Pneumococcal Polysaccharide Vaccine in Target Population Aged 2 Years and Above
- ClinicalTrials.gov ID
- NCT07071701
- Acronym / sponsor ID
- PRO-PPV-MA4002-JS
- Conditions
- Pneumococcal Infectious Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19,267 participants (actual)
- Lead sponsor
- Sinovac Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 2 Jul 2022 (actual)
- Primary completion
- 5 Apr 2024 (actual)
- Study completion
- 5 Apr 2024 (actual)
- First posted
- 17 Jul 2025 (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.
An open clinical trial of a 23-valent pneumococcal polysaccharide vaccine (PPV23) developed by Sinovac Life Science Co., Ltd was conducted to evaluate the safety of Sinovac PPV23 in target population of individuals aged 2 years and above. All participants received 1 dose of PPV23 and self-selected whether to receive 1 dose of influenza vaccine at the same time.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acitive safety surveillance group | – | Biological: 23-valent pneumococcal polysaccharide vaccine, Biological: Influenza vaccine |
| Passive safety surveillance group | – | Biological: 23-valent pneumococcal polysaccharide vaccine, Biological: Influenza vaccine |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants aged 2 years old and above.
Key inclusion criteria (3 listed)
- Have voluntarily and at their own expense received the 23-valent pneumococcal polysaccharide vaccine;
- Participants and/or their guardians are able to understand and voluntarily participate in this study and sign an informed consent form;
- Provide valid legal identification.
Key exclusion criteria (0 listed)
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 vaccine23-valent pneumococcal polysaccharide vaccine | Biological | Acitive safety surveillance group, Passive safety surveillance group |
| Influenza vaccineInfluenza vaccine | Biological | Acitive safety surveillance group, Passive safety surveillance group |
Primary outcome
Incidence of adverse reactions to 23-valent pneumonia vaccine within 0-28 days after single and combined vaccination.
Time frame: 28 days after the vaccination
2 secondary outcomes
Incidence of adverse events to 23-valent pneumonia vaccine within 0-28 days after single and combined vaccination.
Time frame: 28 days after the vaccination
Incidence of adverse events to 23-valent pneumonia vaccine within 0-7 days after single and combined vaccination.
Time frame: 7 days after the 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 17 Jul 2025.
- Derived from this study: PubMed 41729368Shi YF, Ju LH, Wang KN, Pan Y, Zou YY, Lu X, Tuo L, Zou WT, Wei MW, Zhao YW, Pan HX. Post-marketing Safety Surveillance of 23-Valent Pneumococcal Polysaccharide Vaccine Administered Alone and Concomitantly with Influenza Vaccine in Individuals Aged 2 Years and Older in China. Infect Dis Ther. 2026 Apr;15(4):1035-1046. doi: 10.1007/s40121-026-01309-4. Epub 2026 Feb 23.
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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?
An observational study of Pneumococcal Infectious Disease, run by Sinovac Biotech 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 0 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 17 Jul 2025. 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.
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?
Incidence of adverse reactions to 23-valent pneumonia vaccine within 0-28 days after single and combined vaccination. (time frame: 28 days after the 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 NCT07071701, 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 17 Jul 2025.