A Phase 3 interventional study of Sinovac PCV13 and Prevenar 13™ in Pneumococcal Infectious Diseases, sponsored by Sinovac Life Sciences Co., Ltd.. Not yet recruiting at 1 site in Philippines. Open to participants aged 42 Days to 89 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-18.
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 infants aged approximately 2 months (42 to 89 days).
The objective of the study is to evaluate the immunogenicity and safety of Sinovac PCV13. The trial is a randomized, double-blind, active controlled phase III clinical trial.
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 Philippines infants aged approximately 2 months (42 to 89 days).
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 Prevenar 13™ manufactured by Pfizer.
About 500 infants aged approximately 2 months (42 to 89 days) will be enrolled. Participants will be randomized in 1:1 ratio to the test group and control group.
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.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
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.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
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.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
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.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
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.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
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.
250 participants aged 2 months (42 to 89 days) will receive 3 doses of Sinovac PCV13 at approximately 2, 4 and 12-15 months of age.Route of administration is intramuscular injection at anterolateral thigh for infants aged younger than 12 months, and at deltoid muscle of upper arm for children aged older than 12 months.
Biological: Sinovac PCV13
250 participants aged 2 months (42 to 89 days) will receive 3 doses of Prevenar 13™ at approximately 2, 4 and 12-15 months of age.Route of administration is intramuscular injection at anterolateral thigh for infants aged younger than 12 months, and at deltoid muscle of upper arm for children aged older than 12 months.
Biological: Prevenar 13™
One dose of Sinovac PCV13 (0.5ml) was administered at 2, 4, and 12-15 months of age.
One dose of Prevenar 13™ (0.5ml) was administered at 2, 4, and 12-15 months of age.
Percentage of participants with pneumococcal serotype-specific IgG antibody concentrations≥0.35 μg/mL .
Non-inferiority criterion: The lower limit of the two-sided 95% CI for the difference (Sinovac-PCV13 minus Prevenar 13™) \> -10% for each serotype at 30 days after dose 2.
Time frame: 30 days after dose 2.
Geometric mean concentrations (GMCs) of serotype-specific IgG antibody.
Non-inferiority criterion: The lower limit of the two-sided 95% CI for the GMC ratio (Sinovac-PCV13/Prevenar 13™) \> 0.5 for each serotype at 30 days after dose 2.
Time frame: 30 days after dose 2
Percentage of participants with pneumococcal serotype-specific IgG antibody concentrations≥0.35 μg/mL .
Non-inferiority criterion: The lower limit of the two-sided 95% CI for the difference (Sinovac-PCV13 minus Prevenar 13™) \> -10% for each serotype at 30 days after dose 3.
Time frame: 30 days after dose 3.
Geometric mean concentrations (GMCs ) of serotype-specific IgG antibody.
Non-inferiority criterion: The lower limit of the two-sided 95% CI for the GMC ratio (Sinovac-PCV13/Prevenar 13™) \> 0.5 for each serotype at 30 days after dose 3.
Time frame: 30 days after dose 3.
Percentage of participants with serotype-specific IgG concentrations ≥ 1.0 μg/mL
Percentage of participants with serotype-specific IgG concentrations ≥ 1.0 μg/mL at 30 days after dose 2
Time frame: 30 days after dose 2
Percentage of participants with serotype-specific IgG concentrations ≥ 1.0 μg/mL .
Percentage of participants with serotype-specific IgG concentrations ≥ 1.0 μg/mL at 30 days after dose 3.
Time frame: 30 days after dose 3
GMC fold increases (GMFRs) in IgG antibody concentrations.
GMC fold increases (GMFRs) in IgG antibody concentrations from before dose 3 to 30 days after dose 3.
Time frame: From before dose 3 to 30 days after dose 3
Percentage of participants with serotype-specific opsonophagocytosis assay (OPA) antibody titers ≥1:8
Percentage of participants with serotype-specific OPA antibody titers ≥1:8 at 30 days after the dose 2.
Time frame: 30 days after the dose 2.
Percentage of participants with serotype-specific OPA antibody titers ≥1:8.
Percentage of participants with serotype-specific OPA antibody titers ≥1:8 at 30 days after the dose 3.
Time frame: 30 days after the dose 3.
Geometric mean titers (GMTs) of serotype-specific OPA antibody.
Geometric mean titers (GMTs) of serotype-specific OPA antibody 30 days after dose 2.
Time frame: 30 days after dose 2.
GMTs of serotype-specific OPA antibody .
GMTs of serotype-specific OPA antibody at 30 days after dose 3.
Time frame: 30 days after dose 3.
GMT fold rises (GMFRs) in OPA titers.
GMT fold rises (GMFRs) in OPA titers from before dose 3 to 30 days after dose 3.
Time frame: From before dose 3 to 30 days after dose 3.
Incidence of adverse reactions
Incidence of adverse reactions within 30 days after each dose.
Time frame: 0-30 days after each dose.
Incidence of adverse reactions
Incidence of adverse reactions within 7 days after each dose
Time frame: 0-7 days after each dose
Incidence of serious adverse events(SAEs)
Incidence of SAEs from dose 1 to 30 days after dose 3
Time frame: From dose 1 to 30 days after dose 3
Percentage of infants with anti-diphtheria toxoid IgG concentrations ≥ 0.1 IU/mL
Percentage of infants with anti-diphtheria toxoid IgG concentrations ≥ 0.1 IU/mL at 30 days after dose 3 of DTwP-HepB-Hib
Time frame: 30 days after dose 3 of DTwP-HepB-Hib
Percentage of infants with anti-tetanus toxoid IgG concentrations ≥ 0.1 IU/mL
Percentage of infants with anti-tetanus toxoid IgG concentrations ≥ 0.1 IU/mL at 30 days after dose 3 of DTwP-HepB-Hib
Time frame: 30 days after dose 3 of DTwP-HepB-Hib
Percentage of participants achieving an anti-acellular pertussis (PT, FHA and PRN antigens) antibody concentration
Percentage of participants achieving an anti-acellular pertussis (PT, FHA and PRN antigens) antibody concentration ≥ the observed anti-pertussis antibody concentration achieved by 95% of Prevenar 13™ recipients at 30 days after dose 3 of DTwP-HepB-Hib
Time frame: 30 days after dose 3 of DTwP-HepB-Hib
Percentage of infants with anti-Haemophilus influenzae type b (PRP) IgG concentration≥0.15 µg/mL
Percentage of infants with anti-Haemophilus influenzae type b (PRP) IgG concentration≥0.15 µg/mL at 30 days after dose 3 of DTwP-HepB-Hib
Time frame: 30 days after dose 3 of DTwP-HepB-Hib
Percentage of infants with anti-Hepatitis B surface antigen (HBsAg) antibody concentrations≥10 mIU/mL
Percentage of infants with anti-Hepatitis B surface antigen (HBsAg) antibody concentrations≥10 mIU/mL at 30 days after dose 3 of DTwP-HepB-Hib
Time frame: 30 days after dose 3 of DTwP-HepB-Hib
Percentage of infants with anti-poliovirus types 1, 2 and 3 neutralizing antibody titers≥1:8
Percentage of infants with anti-poliovirus types 1, 2 and 3 neutralizing antibody titers≥1:8 measured at 30 days after dose 3 of IPV
Time frame: 30 days after dose 3 of IPV
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sinovac Life Sciences Co., Ltd. →