A Lot-to-Lot Consistency Clinical Trial of PCV13
- Summary
- A Phase IIIb clinical trial of 13-valent pneumococcal conjugate vaccine (PCV13)developed by Sinovac Life Science Co., Ltd will be conducted in children aged 2 to 5 years. The objective of the study is to evaluate the the Lot-to-Lot consistency, immunogenicity and safety of Sinovac PCV13. The trial is a randomized, double-blind phase IIIb clinical trial.
- Short title
- A Lot-to-Lot Consistency Clinical Trial of PCV13
- Official title
- A Randomized, Double-Blind Phase Ⅲb Clinical Trial to Evaluate the Lot-to-Lot Consistency, Immunogenicity and Safety of 13-Valent Pneumococcal Conjugate Vaccine in Children Aged 2 to 5 Years
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Not yet recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2027-03-01
- First posted
- 2026-09-22
- Registry last updated
- 2026-09-22
- Primary completion date
- 2027-03-01
- Start date
- 2026-09-01
- Participants
- 1,125
- Participant count basis
- Estimated
- Planned participants
- 1,125
- Protocol amendments
- Randomisation ratio
- 1:1:1
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Sinovac Life Sciences Co., Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07832500
- ClinicalTrials.gov ID
- NCT07832500
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Prevention
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC) 30 days after vaccination
Timeframe: 30 days after vaccination
Equivalence Criterion: The 95% confidence intervals (CIs) for the ratios of serotype-specific IgG geometric mean concentrations (GMCs) between any two lots shall lie entirely within the range of 0.5 to 2.0,as measured by enzyme-linked immunosorbent assay (ELISA) method
Percentage of Pneumococcal serotype-specific IgG antibody concentration ≥0.35 μg/ml (seropositive rate) 30 days after vaccination
Timeframe: 30 days after vaccination
Percentage of IgG antibody concentration ≥0.35 μg/ml at 30 days after vaccination, as measured by ELISA method
Percentage of Pneumococcal serotype-specific IgG antibody concentration ≥1.0 μg/ml 30 days after vaccination
Timeframe: 30 days after vaccination
Percentage of IgG antibody concentration ≥1.0 μg/ml at 30 days after vaccination, as measured by ELISA method
Pneumococcal serotype-specific IgG antibody geometric mean increase (GMI) from pre-vaccination up to 30 days post-vaccination
Timeframe: Pre-vaccination up to 30 days post-vaccination
IgG GMI for the pneumococcal serotypes were measured by ELISA method
Incidence of adverse reactions within 7 days after vaccination
Timeframe: 0-7 days after vaccination
Incidence of adverse reactions within 7 days after vaccination.Adverse reactions consisted of solicited and unsolicited events. Solicited local (injection-site) symptoms included Pain, swelling, erythema, induration, pruritus, solicited systemic (non-injection-site) symptoms included Fever (axillary temperature), decreased appetite, diarrhoea, vomiting, nausea, cough, lethargy, headache, hypersensitivity reaction
Incidence of adverse reactions within 30 days after vaccination
Timeframe: 0-30 days after vaccination
Incidence of adverse reactions within 30 days after vaccination.Adverse reactions consisted of solicited and unsolicited events. Solicited local (injection-site) symptoms included Pain, swelling, erythema, induration, pruritus, solicited systemic (non-injection-site) symptoms included Fever (axillary temperature), decreased appetite, diarrhoea, vomiting, nausea, cough, lethargy, headache, hypersensitivity reaction
Incidence of serious adverse events (SAE) within 6 months after vaccination
Timeframe: 0-6 months after vaccination
Incidence of serious adverse reactions within 6 months after vaccination
- Sex
- All
- Age groups
- Children
- Minimum age
- 2 Years
- Maximum age
- 5 Years
- Healthy volunteers
- Yes
- Healthy children aged 2 to 5 years with stable health status
- Participants and their legal representative provide legal proof of identity, as well as vaccination record
- Participants' legal representative understand and voluntarily sign the informed consent form
- Willing and able to comply with all scheduled visits, sample collection, vaccination and other study procedures, and maintain accessible contact throughout the study period.
- Received any pneumococcal vaccine prior to enrollment
- History of invasive pneumococcal diseases or other pneumococcal diseases 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 anaphylactic shock
- History of severe diseases judged by the investigator to interfere with vaccination, including but not limited to cardiovascular and cerebrovascular diseases (e.g., complicated or complex congenital heart disease), hematological diseases (e.g., severe anemia), liver and renal diseases, digestive system diseases, respiratory diseases (e.g., active pulmonary tuberculosis), malignant tumors, history of major solid organ transplantation, etc.
- Autoimmune diseases or immunodeficiency diseases (including but not limited to systemic lupus erythematosus, rheumatoid arthritis, autoimmune thyroid disease, asplenia, functional asplenia, HIV infection)
- Abnormal coagulation functions (e.g., coagulation factor deficiency, blood coagulation diseases, platelet disorders)
- Have/have suffered from a serious neurological disorder (epilepsy , convulsions or seizures) or mental illness or have a family history of such diseases
- Have received > 14 days of corticosteroids or other immunomodulatory therapy in the past 6 months(defined as ≥2 mg/kg per day with a maximum daily dose of no less than 20 mg prednisone equivalent, or equivalent dosage), or cytotoxic therapy, or plan to receive such therapy during the study period (inhaled, intranasal or topical corticosteroids are excluded)
- Received immunoglobulin or other blood products within 3 months prior to enrollment, or plan to receive such treatment during the study period
- .Received other investigational drugs or vaccines within 30 days prior to enrollment, or plan to receive such drugs or vaccines 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, or known or suspected active infection
- Had fever (axillary temperature> 37.0℃) prior to administration on the scheduled study vaccination day
- In the investigator's judgment, the participant has any other factors that make him or her unfit to participate in the clinical trial
- Xinjiang Uygur Autonomous Region Center for Disease Control and Prevention (Xinjiang Uygur Autonomous Region Academy of Preventive Medicine, Xinjiang Uygur Autonomous Region Public Health Inspection and Testing Center)Ürümqi, China