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.
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
- Type of treatment
- Vaccines, Injection or infusion
- 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
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
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.
- Conditions
- Pneumococcal Infectious Disease
- 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 group | Role | What they receive |
|---|---|---|
| Low-dosage PCV24 (phase Ib) | Experimental | 12 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) | Experimental | 12 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) | Experimental | 12 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 comparator | 12 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) | Experimental | 50 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) | Experimental | 50 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 comparator | 50 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.
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
Pneumococcal serotype-specific opsonophagocytic assay (OPA) geometric mean titer (GMT) (phase II)
OPA GMT 30 days after vaccination
Measured: 30 days after vaccination
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
Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC)(phase II)
IgG GMC 30 days after vaccination
Measured: 30 days after vaccination
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)
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
Incidence of adverse reactions
Incidence of adverse reactions within 7 days after vaccination
Measured: 0-7 days after vaccination
Incidence of serious adverse reactions(SAE)
Incidence of SAE within 6 months after vaccination
Measured: 0-6 months after vaccination
Pneumococcal serotype-specific OPA GMI(phase II)
OPA GMI 30 days after vaccination
Measured: 30 days after vaccination
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.
- First posted21 Apr 2026
- Study start18 Jun 2025
- Primary completion26 Feb 2026
- Study completion26 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal Infectious DiseaseStudies 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 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)
Sponsor and investigators
- Lead sponsor
- Sinovac Life Sciences Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Weijun Hu, Principal investigator, Shaanxi Provincial Center for Disease Control and Prevention
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