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Pneumococcal Infectious DiseasePhase 1NCT06474377

Clinical Trial of PCV24 in Adults

A Phase 1 study testing Sinovac PCV24 formulation 1, Sinovac PCV24 formulation 2 and Pneumovax® 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 I clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24) developed by Sinovac Life Science Co., Ltd will be conducted in adults aged 18 years and older. 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 PCV24 formulation 1, Sinovac PCV24 formulation 2 and Pneumovax®
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
170 participants
Where
1 siteChina
Study dates
21 Jun 2024to 26 Feb 2025
Phase
Phase 1
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 volunteers who are aged 18 years and older, and provide legal proof of identity;
  • Participants understand and voluntarily sign the informed consent form;
  • Participants can follow all study procedures and stay in contact during the study.

Who cannot join

  • Received any pneumococcal vaccine prior to enrollment;
  • History of invasive pneumococcal diseases (IPDs) or other pneumococcal diseases caused by Streptococcus pneumoniae, as confirmed by laboratory tests;
  • History of allergy or 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 (such as Down syndrome, thalassemia, or G6PD deficiency), severe malnutrition;
  • Have uncontrolled chronic diseases or history of severe diseases, including but not limited to cardiovascular diseases, such as hypertension uncontrolled by drugs (measurement on site: systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg) and coronary heart disease, metabolic diseases (such as uncontrolled diabetes), hematological diseases (e.g. severe anemia, hemophilia), liver and kidney diseases, digestive diseases, respiratory diseases (such as active tuberculosis), 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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  • Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets level), history of obvious bleeding, hematoma or bruising after intramuscular injection or venipuncture.
  • Have/have suffered from a serious neurological disorder (epilepsy or convulsions) 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 its equivalent) 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 prior to enrollment, or plan to receive such treatment during the study period;
  • Received other investigational drugs or vaccines within 30 days prior to enrollment, or plan to receive such drugs or vaccines during the study;
  • Received live attenuated vaccine within 14 days prior to enrollment;
  • Received subunit or inactivated or other vaccine within 7 days prior to enrollment;
  • Acute diseases or acute onset of chronic diseases within 7 days prior to enrollment, or known or suspected active infection;
  • Women who are breastfeeding;
  • Fertile women aged 18-59 years who plan to become pregnant or cannot use effective contraception or have egg donation plans from enrollment to 3 months after the study intervention;
  • Women who are pregnant (as judged by the participant's blood pregnancy test);
  • Had fever (axillary temperature> 37.0℃) before vaccination;
  • Abnormalities in clinical laboratory indicators that exceed reference range and are clinically significant.
  • 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

  • Jiangsu Provincial Center for Disease Control and Prevention

    Nanjing, Jiangsu, 210009

Other trials in China

About this study

Official title: A Randomized, Double-blind, Controlled Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 24-valent Pneumococcal Conjugate Vaccine in Adults 18 Years of Age and Older

A Phase I clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24) developed by Sinovac Life Science Co., Ltd will be conducted in adults aged 18 years and older. The objective of the study is to evaluate the safety and immunogenicity of Sinovac PCV24. The trial is a randomized, double-blind, controlled Phase I clinical trial.

Read the detailed description

A phase I 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 18 years and older. The trial is a randomized, double-blind and active 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 the Pneumovax® manufactured by MSD. The placebo is 0.9%NaCl solution.

A total of at least 168 participants will be enrolled, including 84 adults aged 18-59 years and 84 elderly people aged ≥60 years. Participants will be randomized in a 2:2:2:1 ratio to receive one dose of PCV24 formulation 1, PCV24 formulation 2, Pneumovax® or placebo.

Being tested
Sinovac PCV24 formulation 1, Sinovac PCV24 formulation 2, Pneumovax®, Placebo
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 PCV24 formulation 1Biological

    One dose of Sinovac PCV24 formulation 1（0.5mL）

  • Sinovac PCV24 formulation 2Biological

    One dose of Sinovac PCV24 formulation 2（0.5mL）

  • Pneumovax®Biological

    One dose of Pneumovax® (0.5 mL) contains 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F and 33F saccharides.

  • PlaceboBiological

    0.5 mL of 0.9%NaCl solution (normal saline)

Study groups in NCT06474377
Study groupRoleWhat they receive
Experimental: Sinovac PCV24 formulation 1Experimental48 participants will be randomized to receive Sinovac PCV24 formulation 1. Route of administration is intramuscular injection at deltoid muscle of upper arm. Immunization schedule is 1 dose.
Receives: Biological: Sinovac PCV24 formulation 1
Experimental: Sinovac PCV24 formulation 2Experimental48 participants will be randomized to receive Sinovac PCV24 formulation 2. Route of administration is intramuscular injection at deltoid muscle of upper arm. Immunization schedule is 1 dose.
Receives: Biological: Sinovac PCV24 formulation 2
Active control: Pneumovax®Active comparator48 participants will be randomized to receive Pneumovax®. Route of administration is intramuscular injection at deltoid muscle of upper arm. Immunization schedule is 1 dose.
Receives: Biological: Pneumovax®
Placebo: Normal salinePlacebo comparator24 participants will be randomized to receive placebo. Route of administration is intramuscular injection at deltoid muscle of upper arm. Immunization schedule is 1 dose.
Receives: Biological: Placebo

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 within 30 days after vaccination

    Measured: 0-30 days after vaccination

Secondary outcomes (9)

  1. Incidence of adverse reactions

    Incidence of adverse reactions within 7 days after vaccination

    Measured: 0-7 days after vaccination

  2. Incidence of serious adverse events (SAE)

    Incidence of SAE during the period of safety monitoring

    Measured: 0-6 months after vaccination

  3. Incidence of clinically significant abnormality in laboratory examination tests

    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

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

    IgG GMC 30 days after vaccination

    Measured: 30 days after vaccination

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

    IgG GMI 30 days after vaccination

    Measured: 30 days after vaccination

  6. Proportion of pneumococcal serotype-specific IgG antibody concentration increase≥4

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

    Measured: 30 days after vaccination

  7. Pneumococcal serotype-specific opsonophagocytic assay (OPA) geometric mean titer (GMTs)

    OPA GMT 30 days after vaccination

    Measured: 30 days after vaccination

  8. Pneumococcal serotype-specific OPA GMI

    OPA GMI 30 days after vaccination

    Measured: 30 days after vaccination

  9. Proportion of pneumococcal serotype-specific OPA antibody titer increase≥4

    Proportion of OPA antibody titer increase≥four folds 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 posted25 Jun 2024
  2. Study start21 Jun 2024
  3. Primary completion26 Aug 2024
  4. Study completion26 Feb 2025

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
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
170 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06474377
Sponsor's protocol ID
PRO-PCV24-1001
Status last verified
Apr 2025
First submitted
19 Jun 2024
Last updated
16 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Sinovac PCV24 formulation 1, Sinovac PCV24 formulation 2 and Pneumovax® 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 21 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 Apr 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. 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 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.

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). 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 NCT06474377.

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 Apr 2025.

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