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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07832500
- Acronym / sponsor ID
- PRO-PCV-3002
- Conditions
- Pneumococcal Infectious Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,125 participants (estimated)
- Lead sponsor
- Sinovac Life Sciences Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 22 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PCV13 Lot 1 | Experimental | Biological: Sinovac PCV13 lot 1375 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 |
| PCV13 Lot 2 | Experimental | Biological: Sinovac PCV13 lot 2375 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 |
| PCV13 Lot 3 | Experimental | Biological: Sinovac PCV13 lot 3375 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 |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sinovac PCV13 lot 1One dose of Sinovac PCV13 lot 1 (0.5ml) was administered | Biological | PCV13 Lot 1 |
| Sinovac PCV13 lot 2One dose of Sinovac PCV13 lot 2 (0.5ml) was administered | Biological | PCV13 Lot 2 |
| Sinovac PCV13 lot 3One dose of Sinovac PCV13 lot 3(0.5ml) was administered | Biological | PCV13 Lot 3 |
Primary outcome
Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC) 30 days after vaccination
Time frame: 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
6 secondary outcomes
Percentage of Pneumococcal serotype-specific IgG antibody concentration ≥0.35 μg/ml (seropositive rate) 30 days after vaccination
Time frame: 30 days after vaccination
Percentage of Pneumococcal serotype-specific IgG antibody concentration ≥1.0 μg/ml 30 days after vaccination
Time frame: 30 days after vaccination
Pneumococcal serotype-specific IgG antibody geometric mean increase (GMI) from pre-vaccination up to 30 days post-vaccination
Time frame: Pre-vaccination up to 30 days post-vaccination
Incidence of adverse reactions within 7 days after vaccination
Time frame: 0-7 days after vaccination
Incidence of adverse reactions within 30 days after vaccination
Time frame: 0-30 days after vaccination
Incidence of serious adverse events (SAE) within 6 months after vaccination
Time frame: 0-6 months after vaccination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xie na (19990151052, xn@xjcdc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC) 30 days after vaccination (time frame: 30 days after vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.