Clinical Trial of PCV24 in Infants Aged 2-23 Months

NCT06800261
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Phase
Phase 1
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Recruitment status
Recruiting
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Participants
180
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Lead sponsor
Sinovac Life Sciences Co., Ltd.
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Start date
2025-05-08
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Number of sites
2
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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.
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Short title
Clinical Trial of PCV24 in Infants Aged 2-23 Months
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Official title
A Randomized, Double-blind, Positive Controlled Phase Ib Clinical Trial to Evaluate the Safety and Immunogenicity of 24-valent Pneumococcal Conjugate Vaccine in Children Aged 2 (Minimum 42 Days)-23 Months
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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 1
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Study type
Interventional
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Completion date
2026-06-01
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First posted
2025-01-29
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Registry last updated
2026-01-28
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Primary completion date
2026-06-01
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Start date
2025-05-08
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Participants
180
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Participant count basis
Estimated
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Planned participants
180
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Protocol amendments
1
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Randomisation ratio
1:1
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Number of sites
2
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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
NCT06800261
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ClinicalTrials.gov ID
NCT06800261
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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. Incidence of adverse reactions

    Timeframe: 0-30 days after vaccination

    Incidence of adverse reactions within 30 days after vaccination

  1. Incidence of adverse reactions

    Timeframe: 0-7 days after vaccination

    Incidence of adverse reactions within 7 days after vaccination

  2. Incidence of serious adverse events (SAE)

    Timeframe: from vaccination to 6 months after final dose

    Incidence of SAE during the period of safety monitoring

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

    Timeframe: 30 days after primary vaccination

    IgG GMC 30 days after primary vaccination

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

    Timeframe: 30 days after primary vaccination

    IgG GMI 30 days after primary vaccination

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

    Timeframe: 30 days after primary vaccination

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

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

    Timeframe: 30 days after primary vaccination

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

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Children
Minimum age
42 Days
Maximum age
23 Months
Healthy volunteers
Yes

  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 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. 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. 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 platelets 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 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. Received blood products prior to enrollment within 3 months prior to enrollment, or plans to receive such therapies during the study. Receipt of Hepatitis B immunoglobulin one month prior to enrollment is an exception.
  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

  • Shandong Provincial Center for Disease Control and PreventionJinan, ChinaNot yet recruiting
  • Shanxian Center for Disease Control and PreventionShancheng, ChinaRecruiting
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)