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RecruitingNCT07300644Updated Dec 24, 2025

Clinical Trial of PCV24 in Infants and Children Aged 2 Months to 5 Years

A Phase 2 interventional study of Sinovac PCV24 and Prevnar® in Pneumococcal Infectious Disease, sponsored by Sinovac Life Sciences Co., Ltd.. Recruiting at 3 sites in China. Open to participants aged 42 Days to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-24.

Sponsored by Sinovac Life Sciences Co., Ltd. (part of Sinovac Biotech Co., Ltd) · Phase 2, Interventional, and Prevention

From the registry’s dates

  • Started Nov 2025; still recruiting 11 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
420
Allocation
Randomized
Ages
42 Days to 5 Years
Sex
All
01

Study summary

A Phase 2 clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24) developed by Sinovac Life Science Co., Ltd will be conducted in the pediatric population aged 2 months (minimum 42 days) to 5 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 2 clinical trial.

Read the detailed description

A phase 2 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 the Chinese pediatric population aged 2 months (minimum 42 days) to 5 years. 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 Prevenar13®, manufactured by Pfizer.

A total of at least 420 participants aged 2 months (minimum 42 days) to 5 years will be enrolled. Participants will be randomized in a 1:1 ratio to the test group and control group.

02

Conditions studied

  • Pneumococcal Infectious Disease

Keywords

  • PCV24
  • Phase 2
03

In context

Pneumococcal Infections

298 studies on the registry are indexed under Pneumococcal Infections; 26 are open to participants now.

This study's planned enrollment of 420 is above the median of 373 across 253 interventional studies indexed under Pneumococcal Infections.

Browse Pneumococcal Infections studies →

Lead sponsor

Sinovac Life Sciences Co., Ltd. is the lead sponsor of 26 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
42 Days to 5 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Healthy infants who are aged 2 months (42-89 days), 7-11 months, 12-23 months, and 2-5 years;
  2. The participants' guardian provides a legal identity document and the participants' vaccination record;
  3. The participant's guardian understands and voluntarily signs the form;
  4. Follow all study procedures and stay in contact during the study.

Exclusion criteria

Exclusion Criteria:

  1. Received any pneumococcal vaccine prior to enrollment;
  2. History of invasive pneumococcal diseases or other pneumococcal diseases caused by Streptococcus pneumoniae, as confirmed by laboratory tests;
  3. History of severe adverse reactions to the vaccine or vaccine components, or history of allergy, such as urticaria, dyspnea, angioneurotic edema, anaphylactic shock;
  4. Low birth weight (\<2.5kg), or premature infant (gestation weeks \< 37 weeks) (applies to infants younger than 12 months);
  5. History of abnormal labor during delivery (planned cesarean section is excluded), history of asphyxia rescue and nervous system damage (applies to infants younger than 12 months);
  6. Severe congenital malformations or developmental disorders, genetic defects, or malnutrition;
  7. Have uncontrolled chronic diseases or history of severe diseases, including but not limited to cardiovascular diseases (e.g. congenital heart disease), hematological diseases (e.g. severe anemia), liver and kidney diseases, digestive diseases, respiratory diseases (such as active tuberculosis), malignant tumors and major functional organ transplantation history;
  8. diseases, immunodeficiency diseases (including but not limited to systemic lupus erythematosus, rheumatoid arthritis, autoimmune thyroid disease, asplenia, functional asplenia, infection);
  9. Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal levels);
  10. Have/have suffered from a serious neurological disorder (epilepsy or convulsions, but a febrile convulsion is not an exclusion criteria ) or mental illness, or have a family history of such diseases;
  11. Consecutively received therapy (excluding spray therapy for allergic rhinitis and surface corticosteroid therapy for acute non-concurrent dermatitis), or other immunoregulatory therapies, or cytotoxic therapy over 14 days within 6 months before vaccination, or plans to receive such therapies during the study;
  12. Receipt of immunoglobulins or other blood products within 3 months prior to administration of the vaccine (except for immunoglobulin or rabies immunoglobulin used within 1 month), or planned use of such products during the study period;
  13. Received other investigational drugs or vaccines within 30 days prior to enrollment, or plan to receive such drugs or vaccines during the study;
  14. Received within 14 days prior to enrollment;
  15. Received subunit or inactivated vaccine within 7 days prior to enrollment;
  16. Acute diseases or acute onset of chronic diseases within 7 days prior to enrollment, known or potentially active infection;
  17. Axillary temperature≥ 37.3 Degree Celsius before vaccination;
  18. In the investigator's judgment, the participant has any other factors that make him or her unfit to participate in the clinical trial.
Terms in these criteria, in plain language(9)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
420 participants (estimated)

Study arms

  • Experimental
    Sinovac PCV24

    Sinovac PCV24 (0.5 mL) is administered intramuscularly according to different immunization schedules.

    Biological: Sinovac PCV24

  • Active comparator
    Prevnar®

    Prevnar® (0.5 mL) is administered intramuscularly according to different immunization schedules.

    Biological: Prevnar®

Interventions

  • BiologicalSinovac PCV24

    Sinovac PCV24 (0.5 mL) is administered intramuscularly according to different immunization schedules.

  • BiologicalPrevnar®

    Prevnar® (0.5 mL) is administered intramuscularly according to different immunization schedules.

06

What researchers measure

Primary outcomes

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

    Time frame: 30 days after primary vaccination

  2. Incidence of adverse reactions

    Time frame: 0-30 days after vaccination

Secondary outcomes

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

    Time frame: 30 days after the 2nd dose of the primary vaccination (2-month-olds), 30 days after primary vaccination (all participants)

  2. OPA antibody levels for each pneumococcal serotype

    Time frame: 30 days after vaccination

  3. Incidence of adverse reactions

    Time frame: 0-7 days after vaccination

  4. Incidence of serious adverse events (SAE)

    Time frame: from vaccination to 6 months after final dose

07

Study locations

3 of 3 sites recruiting
  • Qichun District Center for Disease Prevention and Control
    Huanggang, Hubei, China
    Recruiting
  • Xiangzhou District Center for Disease Prevention and Control
    Xiangyang, Hubei, China
    Recruiting
  • Xian'an District Center for Disease Prevention and Control
    Xianning, Hubei, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2025 (actual). Primary completion is estimated for Sep 2026, 10 months after the start.

Of 23 phase 2 interventional studies under Pneumococcal Infections, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 28. This study's planned 10 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 24, 2025
First posted
Dec 24, 2025
StartActual
Nov 25, 2025
Primary completionEst.
Sep 2026
CompletionEst.
Dec 2027
Last update
Dec 24, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07300644
Responsible party
Sponsor
First posted
Dec 24, 2025
Start date
Nov 25, 2025
Primary completion
Sep 2026 (estimated)
Completion
Dec 2027 (estimated)
Last update
Dec 24, 2025

Study contacts

Ye-qing Tong
Contact
63382251@qq.com
+86 13971078410

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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