Clinical Trial of 13-Valent Pneumococcal Conjugate Vaccine
- Summary
- A Phase Ⅲ clinical trial of 13-valent pneumococcal conjugate vaccine (PCV13) developed by Sinovac Life Science Co., Ltd will be conducted in pediatric population aged 2 months (minimum 6 weeks)-5 years (before 6th birthday). The objective of the study is to evaluate the immunogenicity and safety of Sinovac PCV13.
- Short title
- Clinical Trial of 13-Valent Pneumococcal Conjugate Vaccine
- Official title
- A Phase Ⅲ Clinical Study to Evaluate the Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine (PCV13) in Healthy Infants
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2026-07-30
- First posted
- 2024-09-27
- Registry last updated
- 2026-01-28
- Primary completion date
- 2026-05-12
- Start date
- 2024-10-23
- Participants
- 3,080
- Participant count basis
- Estimated
- Planned participants
- 3,080
- Protocol amendments
- Randomisation ratio
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Sinovac Life Sciences Co., Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06617715
- ClinicalTrials.gov ID
- NCT06617715
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Prevention
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Proportion of pneumococcal serotype-specific IgG antibody concentration ≥0.35 μg/ml (seropositive rate)
Timeframe: 30 days after primary vaccination
Proportion of serotype-specific IgG concentration ≥0.35 μg/ml
Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC)
Timeframe: 30 days after primary vaccination
IgG GMC
Proportion of pneumococcal serotype-specific IgG antibody concentration ≥0.35 μg/ml (seropositive rate)
Timeframe: 30 days after booster vaccination
Proportion of serotype-specific IgG concentration ≥0.35 μg/ml
Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC)
Timeframe: 30 days after booster vaccination
IgG GMC
Proportion of pneumococcal serotype-specific OPA antibody GMT≥1:8
Timeframe: 30 days after primary vaccination
Proportion of participants with pneumococcal serotype-specific OPA antibody titers ≥ 1:8
Pneumococcal serotype-specific OPA antibody geometric mean titer (GMT)
Timeframe: 30 days after primary vaccination
Pneumococcal serotype-specific OPA antibody GMT
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
Pneumococcal serotype-specific IgG antibody geometric mean increase (GMI)
Timeframe: 30 days after primary vaccination
Pneumococcal serotype-specific IgG GMI
Pneumococcal serotype-specific OPA antibody geometric mean increase(GMI)
Timeframe: 30 days after primary vaccination
Pneumococcal serotype-specific OPA antibody GMI
Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 1.0 μg/mL
Timeframe: 30 days after booster vaccination
Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 1.0 μg/mL
Pneumococcal serotype-specific IgG antibody geometric mean increase (GMI)
Timeframe: 30 days after booster vaccination
Pneumococcal serotype-specific IgG GMI
Proportion of participants with pneumococcal serotype-specific OPA titers ≥ 1:8 (seropositive rate)
Timeframe: 30 days after booster vaccination
Proportion of participants with pneumococcal serotype-specific OPA titers ≥ 1:8 (seropositive rate)
Pneumococcal serotype-specific OPA antibody geometric mean titer (GMT)
Timeframe: 30 days after booster vaccination
Pneumococcal serotype-specific OPA antibody GMT
Pneumococcal serotype-specific OPA antibody geometric mean increase(GMI)
Timeframe: 30 days after booster vaccination
Pneumococcal serotype-specific OPA antibody GMI
Safety of Sinovac PCV13
Timeframe: 0-30 days within each dose
Incidence of adverse reactions
Safety of Sinovac PCV13
Timeframe: 6 months within final dose
Incidence of serious adverse events
- Sex
- All
- Age groups
- Children
- Minimum age
- 6 Weeks
- Maximum age
- 5 Years
- Healthy volunteers
- Yes
- Healthy infants or children who are aged 2 months (at least 6 weeks), 7-11 months, 12-23 months and 2-5 years (before the 6th birthday);
- Participants' guardians provide legal identity document and participants' vaccination record;
- Participants' guardians understand and voluntarily sign the informed consent form;
- Participants' guardians can follow all study procedures and stay in contact during the study.
- Received any pneumococcal vaccine prior to enrollment;
- History of bacterial pneumonia or invasive pneumococcal diseases (IPDs) caused by Streptococcus pneumoniae, as confirmed by laboratory tests;
- History of allergy or adverse reactions to the vaccine or vaccine components, or history of allergy, such as urticaria, dyspnea, angioedema and abdominal pain;
- History of dystocia, asphyxia rescue and nervous system damage at birth for infants under 2 years of age;
- Congenital malformations or developmental disorders, genetic defects, severe malnutrition, history of asthma;
- Autoimmune diseases (such as systemic lupus erythematosus), immunodeficiency diseases or immunosuppressive diseases (such as AIDS, organ transplantation);
- Severe cardiovascular diseases, diabetes, liver diseases, kidney diseases, malignant tumours.
- Have/have suffered from a serious neurological disorder (epilepsy or convulsions) or mental illness or have a family history of such diseases.
- History of thyroidectomy, asplenia, functional asplenia; asplenia or splenectomy caused by any reasons;
- Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets level), history of obvious bleeding, hematoma or bruising after intramuscular injection or venipuncture.
- Consecutively received ≥14 days of corticosteroid, any other immunosuppressive therapy (excluding corticosteroid spray therapy for allergic rhinitis and surface corticosteroid therapy for acute non-concurrent dermatitis), or cytotoxic therapy prior to enrollment for infants aged 6 weeks to 2 months or within 6 months prior to enrollment for children aged 7 months to 5 years.
- Received blood products prior to enrollment for children aged 2 months or within 3 months prior to enrollment for children aged 7 months to 5 years. Receipt of Hepatitis B immunoglobulin one month prior to enrollment is an exception.
- Received other investigational drugs within 60 days prior to enrollment, or plan to receive such drugs during the study;
- Received live attenuated vaccine within 14 days prior to enrollment;
- Received subunit or inactivated or other vaccine within 7 days prior to enrollment;
- Acute diseases or acute onset of chronic diseases within 7 days prior to enrollment;
- Had fever (axillary temperature≥ 37.3 Degree Celsius) before vaccination;
- In the investigator's judgment, the participant has any other factors that make him or her unfit to participate in the clinical trial.
- Henan Provincial Center for Disease Control and PreventionZhengzhou, ChinaRecruiting
Related records
Drugs (2)
Lead sponsors (1)
Conditions (1)
- Pneumococcal infection Primary condition