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Pneumococcal Infectious DiseasePhase 1/2NCT07543198

Clinical Trial of PCV24 in Adults Aged ≥18 Years

A Phase 1/2 study testing Sinovac Low-dosage PCV24, Sinovac Middle-dosage PCV24 and Sinovac High-dosage PCV24 in people with Pneumococcal Infectious Disease, run by Sinovac Life Sciences Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A Phase Ib/II clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24)developed by Sinovac Life Science Co., Ltd will be conducted in adults aged ≥18 years. The objective of the study is to evaluate the safety and immunogenicity of Sinovac PCV24. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Pneumococcal Infectious Disease
What is being tested?
Sinovac Low-dosage PCV24, Sinovac Middle-dosage PCV24 and Sinovac High-dosage PCV24
Could I receive a placebo?
No, everyone receives an active treatment
How many people
385 participants
Where
1 siteChina
Study dates
18 Jun 2025to 26 Feb 2026
Phase
Phase 1/2
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy adults aged ≥18 years, who can provide legal identification documents
  • Fully understand and agree to sign the informed consent form
  • Willing and able to follow all study procedures and stay in contact during the study

Who cannot join

  • Received any pneumococcal vaccine;
  • History of invasive pneumococcal diseases or other pneumococcal diseases caused by Streptococcus pneumoniae, as confirmed by laboratory tests;
  • History of allergy or serious adverse reactions to the vaccine or vaccine components, or history of allergy, such as urticaria, dyspnea, angioedema and anaphylactic shock;
  • Congenital malformations or developmental disorders, genetic defects, severe malnutrition;
  • Have uncontrolled chronic diseases or history of severe diseases, including but not limited to cardiovascular diseases, metabolic diseases, hematological diseases,liver and kidney diseases, digestive diseases, respiratory diseases , malignant tumors and major functional organ transplantation history;
  • Autoimmune diseases or immunodeficiency diseases (including but not limited to systemic lupus erythematosus, rheumatoid arthritis,autoimmune thyroid disease, asplenia, functional asplenia, HIV infection);
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  • Abnormalities in coagulation function (such as deficiency of coagulation factors, coagulation disorders, and abnormalities of platelets);
  • Have/have suffered from a serious neurological disorder (epilepsy , convulsions or seizures) or mental illness or have a family history of such diseases;
  • Long-term alcohol or drug abuse;
  • Have received > 14 days of immunosuppressive or other immunomodulatory therapy((such as prednisone ≥20 mg/day, or an equivalent dose)) in the past 6 months, or cytotoxic therapy, or plan to receive such therapy during the study period;
  • Received immunoglobulin or other blood products within 3 months before receiving the l vaccine, or plan to receive such treatment during the study period;
  • Received other investigational drugs or vaccines within 30 days before receiving the vaccine, or plan to receive such drugs or vaccines during the study;
  • Received live attenuated vaccine within 14 days before receiving the vaccine;
  • Received subunit or inactivated or other vaccine within 7 days before receiving the vaccine;
  • Acute diseases or acute onset of chronic diseases within the past 7 days , or known or suspected active infection;
  • Women who are breastfeeding or pregnant, or women of childbearing potential who plan to become pregnant or have egg donation plans from the time of signing the informed consent form until 6 months after the study intervention;
  • Participants who have a fever on the day of the planned trial vaccine, with an axillary temperature >37.0°C before vaccination;
  • Abnormalities in clinical laboratory indicators that exceed reference range and are clinically significant(Applicable only to phase Ib)
  • In the investigator's judgment, the participant has any other factors that make him or her unfit to participate in the clinical trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shaanxi Provincial Center for Disease Control and Prevention

    Xi'an, Shaanxi

Other trials in China

About this study

Official title: A Randomized, Double-blind, Positive Controlled Phase Ib/II Clinical Trial to Evaluate the Safety and Immunogenicity of 24-valent Pneumococcal Conjugate Vaccine in Adults Aged ≥18 Years

A Phase Ib/II clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24)developed by Sinovac Life Science Co., Ltd will be conducted in adults aged ≥18 years.

The objective of the study is to evaluate the safety and immunogenicity of Sinovac PCV24. The trial is a randomized, double-blind, Positive Controlled phase Ib/II clinical trial.

Read the detailed description

A phase Ib/II clinical trial of the study of 24-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV24) developed by Sinovac Life Science Co., Ltd (Sinovac) will be conducted in Chinese adults aged ≥18years.

The trial is a randomized, double-blind, positive controlled study. The objective of this study is to evaluate the safety and immunogenicity of PCV24 manufactured by Sinovac Life Science Co., Ltd. The active control vaccine is Pneumovax® manufactured by MSD.

Being tested
Sinovac Low-dosage PCV24, Sinovac Middle-dosage PCV24, Sinovac High-dosage PCV24, Pneumovax®
Medical subject headings
Pneumococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sinovac Low-dosage PCV24Biological

    One dose of Sinovac Low-dosage PCV24 (0.5mL)

  • Sinovac Middle-dosage PCV24Biological

    One dose of Sinovac Middle-dosage PCV24(0.5mL)

  • Sinovac High-dosage PCV24Biological

    One dose of Sinovac High-dosage PCV24(0.5mL)

  • Pneumovax®Biological

    One dose of PPV23 manufactured by MSD

Study groups in NCT07543198
Study groupRoleWhat they receive
Low-dosage PCV24 (phase Ib)Experimental12 Participants aged 18-49years and 12 Participants aged ≥50years will receive Sinovac Low-dosage PCV24 . Route of administration is intramuscular injection at deltoid muscle of upper arm.Immunization schedule is 1 dose
Receives: Biological: Sinovac Low-dosage PCV24
Middle-dosage PCV24(phase Ib)Experimental12 Participants aged 18-49 years and 12 Participants aged ≥50years will receive Sinovac Middle-dosage PCV24 . Route of administration is intramuscular injection at deltoid muscle of upper arm.Immunization schedule is 1 dose
Receives: Biological: Sinovac Middle-dosage PCV24
High-dosage PCV24(phase Ib)Experimental12 Participants aged 18-49years will receive Sinovac High-dosage PCV24 . Route of administration is intramuscular injection at deltoid muscle of upper arm.Immunization schedule is 1 dose
Receives: Biological: Sinovac High-dosage PCV24
Pneumovax®(phase Ib)Active comparator12 Participants aged 18-49years and 6 Participants aged ≥50years will receive Pneumovax®(PPV23) . Route of administration is intramuscular injection at deltoid muscle of upper arm.Immunization schedule is 1 dose
Receives: Biological: Pneumovax®
Low-dosage PCV24(phase II)Experimental50 Participants aged 18-49years and 50 Participants aged ≥50years will receive Sinovac Low-dosage PCV24 . Route of administration is intramuscular injection at deltoid muscle of upper arm.Immunization schedule is 1 dose
Receives: Biological: Sinovac Low-dosage PCV24
Middle-dosage PCV24(phase II)Experimental50 Participants aged 18-49years and 50 Participants aged ≥50years will receive Sinovac Middle-dosage PCV24 . Route of administration is intramuscular injection at deltoid muscle of upper arm.Immunization schedule is 1 dose
Receives: Biological: Sinovac Middle-dosage PCV24
Pneumovax®(phase II)Active comparator50 Participants aged 18-49years and 50 Participants aged ≥50years will receive Pneumovax®(PPV23) . Route of administration is intramuscular injection at deltoid muscle of upper arm.Immunization schedule is 1 dose
Receives: Biological: Pneumovax®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse reactions

    Incidence of adverse reactions of different doses of PCV24 in adults aged ≥18 years within 30 days after vaccination

    Measured: 0-30 days after vaccination

  2. Pneumococcal serotype-specific opsonophagocytic assay (OPA) geometric mean titer (GMT) (phase II)

    OPA GMT 30 days after vaccination

    Measured: 30 days after vaccination

  3. Proportion of pneumococcal serotype-specific OPA antibody titer increase≥4-fold(phase II)

    Proportion of OPA antibody titer increase≥four folds 30 days after vaccination

    Measured: 30 days after vaccination

  4. Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC)(phase II)

    IgG GMC 30 days after vaccination

    Measured: 30 days after vaccination

  5. Proportion of pneumococcal serotype-specific IgG antibody concentration increase≥4-fold(phase II)

    Proportion of IgG antibody concentration increase≥four folds 30 days after vaccination

    Measured: 30 days after vaccination

Secondary outcomes (5)

  1. Incidence of clinically significant abnormality in laboratory examination tests(phase Ib)

    Incidence of clinically significant abnormality in blood routine, blood biochemistry and urine routine test results within 3 days after vaccination

    Measured: 0-3 days after vaccination

  2. Incidence of adverse reactions

    Incidence of adverse reactions within 7 days after vaccination

    Measured: 0-7 days after vaccination

  3. Incidence of serious adverse reactions(SAE)

    Incidence of SAE within 6 months after vaccination

    Measured: 0-6 months after vaccination

  4. Pneumococcal serotype-specific OPA GMI(phase II)

    OPA GMI 30 days after vaccination

    Measured: 30 days after vaccination

  5. Pneumococcal serotype-specific IgG antibody geometric mean increase (GMI)(phase II)

    IgG GMI 30 days after vaccination

    Measured: 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.

  1. First posted21 Apr 2026
  2. Study start18 Jun 2025
  3. Primary completion26 Feb 2026
  4. Study completion26 Feb 2026

Resources

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 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
385 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07543198
Sponsor's protocol ID
PRO-PCV24-1004
Status last verified
Apr 2026
First submitted
14 Apr 2026
Last updated
21 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Sinovac Low-dosage PCV24, Sinovac Middle-dosage PCV24 and Sinovac High-dosage PCV24 in people with Pneumococcal Infectious Disease, run by Sinovac Life Sciences 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 19 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 21 Apr 2026. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Incidence of adverse reactions (time frame: 0-30 days after vaccination). The study lists 5 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 NCT07543198.

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 21 Apr 2026.

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