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New treatment option for Pneumococcal Infectious Disease
Official title Clinical Trial of PCV24 in Infants Aged 2-23 Months
ClinicalTrials.gov ID: NCT06800261
What this study is testing
What is Sinovac PCV24?
Sinovac PCV24 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 1b clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24) developed by Sinovac Life Science Co., Ltd will be conducted in pediatric population aged 2 months (minimum 42 days)-23 months. The objective of the study is to evaluate the safety and immunogenicity of Sinovac PCV24.
- Phase 1: an early, usually small safety 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 42 to 23. Healthy volunteers may be eligible.
You may be able to join if
- Healthy infants who are aged 2 months (42-89 days), 7-11 months, 12-23 months;
- Participants' guardian provides legal identity document and participants' vaccination record;
- Participants' guardian understands and voluntarily signs the informed consent form;
- 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 invasive pneumococcal diseases or other pneumococcal diseases caused by Streptococcus pneumoniae, as confirmed by laboratory tests;
- History of severe adverse reactions to the vaccine or vaccine components, or history of allergy, such as urticaria, dyspnea, angioneurotic edema...
- Low birth weight (\<2.5kg), or premature infant (gestation weeks \< 37 weeks) (applies to infants younger than 12 months);
- History of abnormal labor during delivery (planned cesarean section is excluded), history of asphyxia rescue and nervous system damage (applies to...
- Congenital malformations or developmental disorders, genetic defects, severe malnutrition;
See the full eligibility criteria
- Healthy infants who are aged 2 months (42-89 days), 7-11 months, 12-23 months;
- Participants' guardian provides legal identity document and participants' vaccination record;
- Participants' guardian understands and voluntarily signs the informed consent form;
- Follow all study procedures and stay in contact during the study.
- 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 severe adverse reactions to the vaccine or vaccine components, or history of allergy, such as urticaria, dyspnea, angioneurotic edema, anaphylactic shock;
- Low birth weight (\<2.5kg), or premature infant (gestation weeks \< 37 weeks) (applies to infants younger than 12 months);
- History of abnormal labor during delivery (planned cesarean section is excluded), history of asphyxia rescue and nervous system damage (applies to infants younger than 12 months);
- Congenital malformations or developmental disorders, genetic defects, severe malnutrition;
- Have uncontrolled chronic diseases or history of severe diseases, including but not limited to cardiovascular diseases (e.g. congenital heart disease), hematological diseases (e.g. severe anemia), liver and kidney...
- Autoimmune diseases, immunodeficiency diseases (including but not limited to systemic lupus erythematosus, rheumatoid arthritis, autoimmune thyroid disease, asplenia, functional asplenia, HIV infection);
- Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets level), potential bleeding (history of obvious bleeding, hematoma or bruising after...
- Have/have suffered from a serious neurological disorder (epilepsy or convulsions, but febrile convulsion is not an exclusion criteria ) or mental illness or have a family history of such diseases.
- Consecutively received immunosuppressive therapy (excluding corticosteroid spray therapy for allergic rhinitis and surface corticosteroid therapy for acute non-concurrent dermatitis), or other immunoregulatory...
- Received blood products prior to enrollment within 3 months prior to enrollment, or plans to receive such therapies during the study. Receipt of Hepatitis B immunoglobulin one month prior to enrollment is an exception.
- 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 vaccine within 7 days prior to enrollment;
- Acute diseases or acute onset of chronic diseases within 7 days prior to enrollment, known or potentially active infection;
- 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
- Jinan, Shandong, China
- Shancheng, Shandong, 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, 42 days to 23 months. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jinan, Shandong, China; Shancheng, Shandong, 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.