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New treatment option for Pneumococcal Infectious Disease
Official title Clinical Trial of 13-Valent Pneumococcal Conjugate Vaccine
ClinicalTrials.gov ID: NCT06617715
What this study is testing
What is Sinovac PCV13?
Sinovac PCV13 is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for pneumococcal infectious disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 5. Healthy volunteers may be eligible.
You may be able to join if
- 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.
You likely can't join if
- 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...
- 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...
See the full eligibility criteria
- 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.
- 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);
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Zhengzhou, Henan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 weeks to 5 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zhengzhou, Henan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.