A Phase 3 interventional study of Sinovac PCV13 and Prevnar® in Pneumococcal Infectious Disease, sponsored by Sinovac Life Sciences Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 6 Weeks to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-28.
Sponsored by Sinovac Life Sciences Co., Ltd. (part of Sinovac Biotech Co., Ltd) · Phase 3, Interventional, and Prevention
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.
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.
298 studies on the registry are indexed under Pneumococcal Infections; 26 are open to participants now.
This study's planned enrollment of 3,080 is above the median of 373 across 253 interventional studies indexed under Pneumococcal Infections.
Browse Pneumococcal Infections studies →Sinovac Life Sciences Co., Ltd. is the lead sponsor of 26 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants aged 6 weeks-5 years will receive 4 doses of Sinovac PCV13 according to different immunization schedules.
Biological: Sinovac PCV13
Participants aged 6 weeks-5 years will receive 4 doses of Prevnar 13® according to different immunization schedules.
Biological: Prevnar®
One dose of Sinovac PCV13 (0.5 mL) is administered intramuscularly.
One dose of Prevnar® (0.5 mL) is administered intramuscularly.
Proportion of pneumococcal serotype-specific IgG antibody concentration ≥0.35 μg/ml (seropositive rate)
Proportion of serotype-specific IgG concentration ≥0.35 μg/ml
Time frame: 30 days after primary vaccination
Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC)
IgG GMC
Time frame: 30 days after primary vaccination
Proportion of pneumococcal serotype-specific IgG antibody concentration ≥0.35 μg/ml (seropositive rate)
Proportion of serotype-specific IgG concentration ≥0.35 μg/ml
Time frame: 30 days after booster vaccination
Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC)
IgG GMC
Time frame: 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
Time frame: 30 days after primary vaccination
Pneumococcal serotype-specific OPA antibody geometric mean titer (GMT)
Pneumococcal serotype-specific OPA antibody GMT
Time frame: 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
Time frame: 30 days after primary vaccination
Pneumococcal serotype-specific IgG antibody geometric mean increase (GMI)
Pneumococcal serotype-specific IgG GMI
Time frame: 30 days after primary vaccination
Pneumococcal serotype-specific OPA antibody geometric mean increase(GMI)
Pneumococcal serotype-specific OPA antibody GMI
Time frame: 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
Time frame: 30 days after booster vaccination
Pneumococcal serotype-specific IgG antibody geometric mean increase (GMI)
Pneumococcal serotype-specific IgG GMI
Time frame: 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)
Time frame: 30 days after booster vaccination
Pneumococcal serotype-specific OPA antibody geometric mean titer (GMT)
Pneumococcal serotype-specific OPA antibody GMT
Time frame: 30 days after booster vaccination
Pneumococcal serotype-specific OPA antibody geometric mean increase(GMI)
Pneumococcal serotype-specific OPA antibody GMI
Time frame: 30 days after booster vaccination
Safety of Sinovac PCV13
Incidence of adverse reactions
Time frame: 0-30 days within each dose
Safety of Sinovac PCV13
Incidence of serious adverse events
Time frame: 6 months within final dose
Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 0.35 μg/mL (seropositive rate)
Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 0.35 μg/mL (seropositive rate)
Time frame: 1,2,3 years after final dose
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
Time frame: 1,2,3 years after final dose
Pneumococcal serotype-specific IgG geometric mean concentration (GMC)
Pneumococcal serotype-specific IgG geometric mean concentration (GMC)
Time frame: 1,2,3 years after final dose
Proportion of participants aged 2-5 years with pneumococcal serotype-specific OPA titers ≥ 1:8 (seropositive rate)
Proportion of participants aged 2-5 years with pneumococcal serotype-specific OPA titers ≥ 1:8
Time frame: 1,2,3 years after vaccination
Pneumococcal serotype-specific OPA antibody geometric mean titer (GMT) in participants aged 2-5 years
Pneumococcal serotype-specific OPA antibody GMT in participants aged 2-5 years
Time frame: 1,2,3 years after vaccination
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