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

NCT07300644
clinicaltrials.gov
Phase
Phase 2
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Recruitment status
Recruiting
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Participants
420
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Lead sponsor
Sinovac Life Sciences Co., Ltd.
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Start date
2025-11-25
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Number of sites
3
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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.
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Short title
Clinical Trial of PCV24 in Infants and Children Aged 2 Months to 5 Years
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Official title
A Randomized, Double-blind, Positive-controlled Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of 24-valent Pneumococcal Conjugate Vaccine in Children Aged 2 Months (Minimum 42 Days) to 5 Years
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2027-12-01
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First posted
2025-12-24
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Registry last updated
2025-12-24
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Primary completion date
2026-09-01
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Start date
2025-11-25
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Participants
420
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Participant count basis
Estimated
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Planned participants
420
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Protocol amendments
0
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Randomisation ratio
1:1
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Number of sites
3
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Sinovac Life Sciences Co., Ltd.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07300644
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ClinicalTrials.gov ID
NCT07300644
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Prevention
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

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

    Timeframe: 30 days after primary vaccination

  2. Incidence of adverse reactions

    Timeframe: 0-30 days after vaccination

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

    Timeframe: 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

    Timeframe: 30 days after vaccination

  3. Incidence of adverse reactions

    Timeframe: 0-7 days after vaccination

  4. Incidence of serious adverse events (SAE)

    Timeframe: from vaccination to 6 months after final dose

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Children
Minimum age
42 Days
Maximum age
5 Years
Healthy volunteers
Yes

  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 informed consent form;
  4. Follow all study procedures and stay in contact during the study.

  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. Autoimmune diseases, immunodeficiency diseases (including but not limited to systemic lupus erythematosus, rheumatoid arthritis, autoimmune thyroid disease, asplenia, functional asplenia, HIV infection);
  9. Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelet 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 immunosuppressive therapy (excluding corticosteroid 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 investigational vaccine (except for hepatitis B 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 live attenuated vaccine 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.
Sources for eligibility
clinicaltrials.gov

  • Qichun District Center for Disease Prevention and ControlHuanggang, ChinaRecruiting
  • Xiangzhou District Center for Disease Prevention and ControlXiangyang, ChinaRecruiting
  • Xian'an District Center for Disease Prevention and ControlXianning, ChinaRecruiting
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)