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RecruitingNCT06800261Updated Jan 28, 2026

Clinical Trial of PCV24 in Infants Aged 2-23 Months

A Phase 1 interventional study of Sinovac PCV24 and Prevnar® in Pneumococcal Infectious Disease, sponsored by Sinovac Life Sciences Co., Ltd.. Recruiting at 2 sites in China. Open to participants aged 42 Days to 23 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-28.

Sponsored by Sinovac Life Sciences Co., Ltd. (part of Sinovac Biotech Co., Ltd) · Phase 1, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Jun 2026, 5 months ago, but the record still lists the study as recruiting.
  • Started May 2025; still recruiting 1 year 6 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
42 Days to 23 Months
Sex
All
01

Study summary

A Phase 1b clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24) developed by Sinovac Life Science Co., Ltd will be conducted in pediatric population aged 2 months (minimum 42 days)-23 months.

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 clinical trial.

Read the detailed description

A phase 1b 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 pediatric population aged 2 months (minimum 42 days)-23 months. 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 180 participants aged 2 months (minimum 42 days)-23 months will be enrolled. Participants will be randomized in 1:1 ratio to the test group and control group.

02

Conditions studied

  • Pneumococcal Infectious Disease
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 180 is below 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 23 Months
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;
  2. Participants' guardian provides legal identity document and participants' vaccination record;
  3. Participants' 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. Congenital malformations or developmental disorders, genetic defects, severe 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 level), potential bleeding (history of obvious bleeding, hematoma or bruising after intramuscular injection or venipuncture).
  10. Have/have suffered from a serious neurological disorder (epilepsy or convulsions, but 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. Received blood products prior to enrollment within 3 months prior to enrollment, or plans to receive such therapies during the study. Receipt of immunoglobulin one month prior to enrollment is an exception.
  13. Received other 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.

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.

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.

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 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
180 participants (estimated)

Study arms

  • Experimental
    Experimental: Sinovac PCV24

    Participants aged 2 months (minimum 42 days)-23 months will receive Sinovac PCV24 according to different immunization schedules. Route of administration is intramuscular injection at anterolateral thigh for infants aged younger than 12 months, and at deltoid muscle of upper arm for children aged older than 12 months.

    Biological: Sinovac PCV24

  • Active comparator
    Active Comparator: Prevnar®

    Participants aged 2 months (minimum 42 days)-23 months will receive Prevnar 13® according to different immunization schedules. Route of administration is intramuscular injection at anterolateral thigh for infants aged younger than 12 months, and at deltoid muscle of upper arm for children aged older than 12 months.

    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. Incidence of adverse reactions

    Incidence of adverse reactions within 30 days after vaccination

    Time frame: 0-30 days after vaccination

Secondary outcomes

  1. Incidence of adverse reactions

    Incidence of adverse reactions within 7 days after vaccination

    Time frame: 0-7 days after vaccination

  2. Incidence of serious adverse events (SAE)

    Incidence of SAE during the period of safety monitoring

    Time frame: from vaccination to 6 months after final dose

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

    IgG GMC 30 days after primary vaccination

    Time frame: 30 days after primary vaccination

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

    IgG GMI 30 days after primary vaccination

    Time frame: 30 days after primary vaccination

  5. Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 1.0 μg/mL

    Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 1.0 μg/mL

    Time frame: 30 days after primary vaccination

  6. Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 0.35 μg/mL (seropositive rate)

    Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 0.35 μg/mL (seropositive rate)

    Time frame: 30 days after primary vaccination

07

Study locations

1 of 2 sites recruiting
  • Shandong Provincial Center for Disease Control and Prevention
    Jinan, Shandong 250014, China
    Not yet recruiting
  • Shanxian Center for Disease Control and Prevention
    Shancheng, Shandong 250014, China
    Recruiting
    • Shanxian Center for Disease Control and Prevention · Contact
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06800261
Responsible party
Sponsor
First posted
Jan 29, 2025
Start date
May 8, 2025
Primary completion
Jun 2026 (estimated)
Completion
Jun 2026 (estimated)
Last update
Jan 28, 2026

Study contacts

Qing Xu
Contact
xqepi@163.com
18853165516
Qing Xu
principal investigator · Shandong Provincial Center for Disease Control and Prevention

Oversight

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

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