Pneumococcal Infectious DiseasePhase 3NCT06617715
Clinical Trial of 13-Valent Pneumococcal Conjugate Vaccine
A Phase 3 study testing Sinovac PCV13 and Prevnar® in people with Pneumococcal Infectious Disease, run by Sinovac Life Sciences Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 weeks to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Infectious Disease
- What is being tested?
- Sinovac PCV13 and Prevnar®
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,080 participants
- Where
- 1 siteChina
- Study dates
- 23 Oct 2024to 30 Jul 2026
- 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 6 weeks to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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.
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, 1 recruiting
- Recruiting
Henan Provincial Center for Disease Control and Prevention
Zhengzhou, Henan
Yanxia Wang, 13613816598
About this study
Official title: A Phase Ⅲ Clinical Study to Evaluate the Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine (PCV13) in Healthy Infants
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.
Read the detailed description
A phase Ⅲ 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 pediatric population aged 2 months (minimum 6 weeks)-5 years (before the 6th birthday). The trial is a randomized, double-blind, active controlled study. The objective of this study is to evaluate the immunogenicity and safety of PCV13 manufactured by Sinovac Life Science Co., Ltd. The active control vaccine is Prevenar13®. A total of at least 3080 participants aged 6 weeks to 5 years will be enrolled. Participants will be randomized in 1:1 ratio to the test group or control group.
- Conditions
- Pneumococcal Infectious Disease
- Being tested
- Sinovac PCV13, Prevnar®
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sinovac PCV13Biological
One dose of Sinovac PCV13 (0.5 mL) is administered intramuscularly.
Prevnar®Biological
One dose of Prevnar® (0.5 mL) is administered intramuscularly.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Sinovac PCV13 | Experimental | Participants aged 6 weeks-5 years will receive 4 doses of Sinovac PCV13 according to different immunization schedules. Receives: Biological: Sinovac PCV13 |
| Active Comparator: Prevnar® | Active comparator | Participants aged 6 weeks-5 years will receive 4 doses of Prevnar 13® according to different immunization schedules. Receives: Biological: Prevnar® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of pneumococcal serotype-specific IgG antibody concentration ≥0.35 μg/ml (seropositive rate)
Proportion of serotype-specific IgG concentration ≥0.35 μg/ml
Measured: 30 days after primary vaccination
Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC)
IgG GMC
Measured: 30 days after primary vaccination
Secondary outcomes (14)
Proportion of pneumococcal serotype-specific IgG antibody concentration ≥0.35 μg/ml (seropositive rate)
Proportion of serotype-specific IgG concentration ≥0.35 μg/ml
Measured: 30 days after booster vaccination
Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC)
IgG GMC
Measured: 30 days after booster vaccination
Proportion of pneumococcal serotype-specific OPA antibody GMT≥1:8
Proportion of participants with pneumococcal serotype-specific OPA antibody titers ≥ 1:8
Measured: 30 days after primary vaccination
Pneumococcal serotype-specific OPA antibody geometric mean titer (GMT)
Pneumococcal serotype-specific OPA antibody GMT
Measured: 30 days after primary vaccination
Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 1.0 μg/mL
Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 1.0 μg/mL
Measured: 30 days after primary vaccination
Pneumococcal serotype-specific IgG antibody geometric mean increase (GMI)
Pneumococcal serotype-specific IgG GMI
Measured: 30 days after primary vaccination
Pneumococcal serotype-specific OPA antibody geometric mean increase(GMI)
Pneumococcal serotype-specific OPA antibody GMI
Measured: 30 days after primary vaccination
Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 1.0 μg/mL
Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 1.0 μg/mL
Measured: 30 days after booster vaccination
Pneumococcal serotype-specific IgG antibody geometric mean increase (GMI)
Pneumococcal serotype-specific IgG GMI
Measured: 30 days after booster vaccination
Proportion of participants with pneumococcal serotype-specific OPA titers ≥ 1:8 (seropositive rate)
Proportion of participants with pneumococcal serotype-specific OPA titers ≥ 1:8 (seropositive rate)
Measured: 30 days after booster vaccination
Pneumococcal serotype-specific OPA antibody geometric mean titer (GMT)
Pneumococcal serotype-specific OPA antibody GMT
Measured: 30 days after booster vaccination
Pneumococcal serotype-specific OPA antibody geometric mean increase(GMI)
Pneumococcal serotype-specific OPA antibody GMI
Measured: 30 days after booster vaccination
Safety of Sinovac PCV13
Incidence of adverse reactions
Measured: 0-30 days within each dose
Safety of Sinovac PCV13
Incidence of serious adverse events
Measured: 6 months within final dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start23 Oct 2024
- Primary completion12 May 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal Infectious DiseaseStudies 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
- 3,080 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinovac Life Sciences Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yanxia Wang, Principal investigator, Henan Provincial Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06617715
- Sponsor's protocol ID
- PRO-PCV-3001
- Status last verified
- Jan 2026
- First submitted
- 26 Sep 2024
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No