Pneumococcal Infectious DiseasesPhase 3NCT07832500
A Lot-to-Lot Consistency Clinical Trial of PCV13
A Phase 3 study testing Sinovac PCV13 lot 1, Sinovac PCV13 lot 2 and Sinovac PCV13 lot 3 in people with Pneumococcal Infectious Diseases, run by Sinovac Life Sciences Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Infectious Diseases
- What is being tested?
- Sinovac PCV13 lot 1, Sinovac PCV13 lot 2 and Sinovac PCV13 lot 3
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,125 participants
- Where
- 1 siteChina
- Study dates
- Sep 2026to Mar 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
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, Xinjiang
Xie na, 19990151052, xn@xjcdc.com
About this study
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
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.
Read the detailed description
A phase IIIb clinical trial of the study of 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV13) developed by Sinovac Life Science Co., Ltd (Sinovac) will be conducted in Chinese children aged approximately 2 to 5 years.
The trial is a randomized, double-blind study. The objective of this study is to evaluate theLot-to-Lot consistency, immunogenicity and safety of PCV13 manufactured by Sinovac Life Science Co., Ltd.
A total of at least 1125 participants will be enrolled. Participants wiil be randomized in a 1:1:1 ratio into three groups to receive different lots of commercially manufactured PCV13.
- Conditions
- Pneumococcal Infectious Diseases
- Being tested
- Sinovac PCV13 lot 1, Sinovac PCV13 lot 2, Sinovac PCV13 lot 3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sinovac PCV13 lot 1Biological
One dose of Sinovac PCV13 lot 1 (0.5ml) was administered
Sinovac PCV13 lot 2Biological
One dose of Sinovac PCV13 lot 2 (0.5ml) was administered
Sinovac PCV13 lot 3Biological
One dose of Sinovac PCV13 lot 3(0.5ml) was administered
| Study group | Role | What they receive |
|---|---|---|
| PCV13 Lot 1 | Experimental | 375 participants aged 2-5 years will be randomized to receive Sinovac PCV13 Lot
1. Route of administration is intramuscular injection at deltoid muscle of upper arm. Immunization schedule is 1 dose Receives: Biological: Sinovac PCV13 lot 1 |
| PCV13 Lot 2 | Experimental | 375 participants aged 2-5 years will be randomized to receive Sinovac PCV13 Lot 2. Route of administration is intramuscular injection at deltoid muscle of upper arm. Immunization schedule is 1 dose Receives: Biological: Sinovac PCV13 lot 2 |
| PCV13 Lot 3 | Experimental | 375 participants aged 2-5 years will be randomized to receive Sinovac PCV13 Lot 3. Route of administration is intramuscular injection at deltoid muscle of upper arm. Immunization schedule is 1 dose Receives: Biological: Sinovac PCV13 lot 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC) 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
Measured: 30 days after vaccination
Secondary outcomes (6)
Percentage of Pneumococcal serotype-specific IgG antibody concentration ≥0.35 μg/ml (seropositive rate) 30 days after vaccination
Percentage of IgG antibody concentration ≥0.35 μg/ml at 30 days after vaccination, as measured by ELISA method
Measured: 30 days after vaccination
Percentage of Pneumococcal serotype-specific IgG antibody concentration ≥1.0 μg/ml 30 days after vaccination
Percentage of IgG antibody concentration ≥1.0 μg/ml at 30 days after vaccination, as measured by ELISA method
Measured: 30 days after vaccination
Pneumococcal serotype-specific IgG antibody geometric mean increase (GMI) from pre-vaccination up to 30 days post-vaccination
IgG GMI for the pneumococcal serotypes were measured by ELISA method
Measured: Pre-vaccination up to 30 days post-vaccination
Incidence of adverse reactions within 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
Measured: 0-7 days after vaccination
Incidence of adverse reactions within 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
Measured: 0-30 days after vaccination
Incidence of serious adverse events (SAE) within 6 months after vaccination
Incidence of serious adverse reactions within 6 months after vaccination
Measured: 0-6 months after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal Infectious DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinovac Life Sciences Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xie na, Principal investigator, 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)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07832500
- Sponsor's protocol ID
- PRO-PCV-3002
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No