A Phase 1b Clinical Trial of 13-valent Pneumococcal Polysaccharide Conjugate Vaccine

NCT06183216
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Phase
Phase 1
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Recruitment status
Completed
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Participants
140
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Lead sponsor
Sinovac Research and Development Co., Ltd.
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Start date
2024-01-04
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Number of sites
1
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Summary
A phase 1b clinical trial of 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV13) developed by Sinovac Life Science Co., Ltd will be conducted in children aged 2 months (42-89 days) and 2 to 5 years. The objective of the study is to evaluate the safety and immunogenicity of Sinovac PCV13. The trial is a randomized, double blinded, positive controlled study.
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Short title
A Phase 1b Clinical Trial of 13-valent Pneumococcal Polysaccharide Conjugate Vaccine
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Official title
A Randomized, Double Blinded, Positive Controlled Phase Ⅰb Clinical Trial in Participants Aged 2 Months (42-89 Days) and 2 to 5 Years to Evaluate the Safety and Immunogenicity of 13-valent Pneumococcal Polysaccharide Conjugate Vaccine
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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
Completed
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Phase
Phase 1
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Study type
Interventional
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Completion date
2025-03-26
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First posted
2023-12-27
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Registry last updated
2026-01-28
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Primary completion date
2025-03-26
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Start date
2024-01-04
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Actual participants
140
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Participants
140
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Participant count basis
Actual
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Protocol amendments
2
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Randomisation ratio
1:1
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Number of sites
1
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Sinovac Research and Development Co., Ltd.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06183216
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ClinicalTrials.gov ID
NCT06183216
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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 each dose

    Incidence of adverse reactions within 30 days after each dose

  1. Incidence of adverse reactions

    Timeframe: 0-7 days after each dose

    Incidence of adverse reactions within 7 days after each dose

  2. Incidence of SAE

    Timeframe: 6 months after vaccination for children aged 2-5 years; 1 month after completion of booster vaccination for infants aged 2 months.

    Incidence of SAE during the period of safety monitoring

  3. IgG concentration ≥0.35μg/mL for infants aged 2 months

    Timeframe: 30 days after primary/booster immunization

    The proportion of participants achieving an IgG concentration ≥0.35μg/mL (seropositivity rate) for each serotype 30 days after primary/booster immunization.

  4. IgG concentration ≥1.0μg/mL for infants aged 2 months

    Timeframe: 30 days after primary/booster immunization

    The proportion of participants achieving an IgG concentration ≥1.0μg/mL for each serotype 30 days after primary/booster immunization.

  5. GMCs for infants aged 2 months

    Timeframe: 30 days after primary/booster immunization

    GMCs for each serotype 30 days after primary/booster immunization

  6. GMIs for infants aged 2 months

    Timeframe: 30 days after primary/booster immunization

    GMIs (GMC increase folds) for each serotype 30 days after primary/booster immunization

  7. IgG concentration ≥0.35μg/mL for children aged 2-5 years

    Timeframe: 30 days after vaccination

    The proportion of participants achieving an IgG concentration ≥0.35μg/mL (seropositivity rate) for each serotype 30 days after vaccination.

  8. IgG concentration ≥1.0μg/mL for children aged 2-5 years

    Timeframe: 30 days after vaccination

    The proportion of participants achieving an IgG concentration ≥1.0μg/mL for each serotype 30 days after vaccination.

  9. GMCs for children aged 2-5 years

    Timeframe: 30 days after vaccination

    GMCs for each serotype 30 days after vaccination

  10. GMIs for children aged 2-5 years

    Timeframe: 30 days after vaccination

    GMIs (GMC increase folds) for each serotype 30 days after vaccination

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Children
Minimum age
6 Weeks
Maximum age
5 Years
Healthy volunteers
Yes

  1. Healthy infants aged 2 months (42-89 days); Healthy children aged 2-5 years.
  2. Proven vaccination certificate, birth certificate and legal identification documents
  3. The participants' guardians can understand and voluntarily sign the informed consent form.
  4. Participants and their guardians can obey requirements of the protocol.

  1. Received any pneumococcal vaccine prior to enrollment.
  2. History of culture confirmed bacterial pneumonia or invasive pneumococcal disease (IPD) caused by Streptococcus pneumoniae.
  3. History of allergy to the vaccine or vaccine components, including pneumococcal polysaccharide for each serotype, diphtheria CRM197, aluminum phosphate, succinic acid, polysorbate 80 and sodium chloride; or serious adverse reactions to the vaccine, such as urticaria, dyspnea, angioedema and asthma.
  4. History of dystocia, asphyxia rescue, nervous system damage at birth (only applicable to infants aged 2 months (42-89 days))
  5. Congenital malformations or developmental disorders, genetic defects, severe malnutrition, asthma etc.
  6. Autoimmune disease (such as systemic lupus erythematosus) or immunodeficiency/ immunosuppression (such as HIV, organ transplantation)
  7. Severe cardiovascular diseases, such as diabetes, liver diseases, kidney diseases, malignant tumors.
  8. Family history of mental illness, severe neurological disease (epilepsy or convulsions) or mental illness.
  9. History of thyroidectomy, asplenia, functional asplenia; and asplenia or splenectomy resulting from any condition.
  10. Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets), history of obvious bleeding or bruising after intramuscular injection or venipuncture.
  11. Infants 2 months of age (42-89 days) prior to enrollment/children 2 to 5 years of age 6 months prior to enrollment had been treated with corticosteroids, other immunosuppressive agents (excluding corticosteroid spray therapy for allergic rhinitis, superficial corticosteroid therapy for acute non-concurrent dermatitis) or cytotoxic therapy for ≥14 days
  12. Infants 2 months of age (42-89 days) prior to enrollment/children 2 to 5 years of age 3 months prior to enrollment received blood products within the past 3 months (excluding hepatitis B immunoglobulin within 1 month).
  13. Receipt of other investigational drugs in the past 60 days or have the plan to participate in other clinical trials during this study.
  14. Receipt of attenuated live vaccines in the past 14 days.
  15. Receipt of inactivated or subunit vaccines in the past 7 days.
  16. Acute diseases or acute exacerbation of chronic diseases in the past 7 days.
  17. Axillary temperature ≥37.3 °C.
  18. According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
Sources for eligibility
clinicaltrials.gov

  • Binchuan County Center for Diseases Control and PreventionDali, China
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)