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Tests treatment safety and results for Pneumococcal Disease
Official title A Clinical Trial to Evaluate the Immunogenicity and Safety of the 23-valent Pneumococcal Polysaccharide Vaccine in Healthy People
ClinicalTrials.gov ID: NCT06044077
What this study is testing
What is 23-valent pneumococcal polysaccharide vaccine?
23-valent pneumococcal polysaccharide vaccine is an investigational medicine, being studied as a potential treatment for pneumococcal 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
- This study is a randomized, blinded, parallel controlled phase 3 clinical trial to evaluate the immunogenicity and safety of the 23-valent pneumococcal polysaccharide vaccine in healthy people aged 2 years and above.
- 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 2 and older. Healthy volunteers may be eligible.
You may be able to join if
- Healthy people who meet the observation age of this clinical trial (2 years old and above) and are determined based on medical history, physical...
- people who voluntarily participate and/or the people' legal guardians Or the entrusted person voluntarily agrees for his or her child to participate...
- The subject and/or the subject's legal guardian or principal can abide by the clinical Relevant requirements of the research protocol;
- \ Axillary body temperature \<37.3°C on the day of enrollment. For criteria marked with an asterisk (\ ), if the subject has the conditions specified...
You likely can't join if
- Previous vaccination with marketed or experimental pneumococcal vaccines;
- Previous culture-confirmed history of invasive diseases caused by pneumococcal bacteria;
- History or family history of convulsions, epilepsy, encephalopathy, and mental illness;
- Have a history of severe allergy to any vaccination or drug in the past, be allergic to the ingredients of the experimental vaccine (mainly including...
- Known severe congenital malformations, developmental disabilities or clinically diagnosed serious chronic diseases (such as Down syndrome, diabetes...
- Known or suspected to have serious diseases including: severe respiratory diseases, severe digestive system diseases, severe endocrine system...
See the full eligibility criteria
- Healthy people who meet the observation age of this clinical trial (2 years old and above) and are determined based on medical history, physical examination and the researcher's judgment;
- people who voluntarily participate and/or the people' legal guardians Or the entrusted person voluntarily agrees for his or her child to participate and signs an informed consent form (people aged 8-17 years old must...
- The subject and/or the subject's legal guardian or principal can abide by the clinical Relevant requirements of the research protocol;
- \ Axillary body temperature \<37.3°C on the day of enrollment. For criteria marked with an asterisk (\ ), if the subject has the conditions specified in the criterion, the visit can be rescheduled when they no longer...
- Previous vaccination with marketed or experimental pneumococcal vaccines;
- Previous culture-confirmed history of invasive diseases caused by pneumococcal bacteria;
- History or family history of convulsions, epilepsy, encephalopathy, and mental illness;
- Have a history of severe allergy to any vaccination or drug in the past, be allergic to the ingredients of the experimental vaccine (mainly including pneumococcal polysaccharide, sodium dihydrogen phosphate, disodium...
- Known severe congenital malformations, developmental disabilities or clinically diagnosed serious chronic diseases (such as Down syndrome, diabetes that cannot be controlled by drugs, sickle cell anemia, Guillain-Barré...
- Known or suspected to have serious diseases including: severe respiratory diseases, severe digestive system diseases, severe endocrine system diseases, severe cardiovascular diseases, severe liver and kidney diseases...
- Known or suspected to be immune Academic functional defects include: immunosuppressant treatment (radiotherapy, chemotherapy, corticosteroids, antimetabolites, cytotoxic drugs), HIV infection, etc. within 6 months;
- Have received any treatment within 3 months before enrollment Blood products or globulin treatment, those who have used hepatitis B immune globulin are acceptable;
- Asplenia, functional asplenia or splenectomy;
- \ In the acute infectious period (including recovery period) or acute exacerbation of chronic disease within 3 days before enrollment, or need or plan to use intravenous or oral steroids within 1 month after vaccination;
- \ Antipyretic analgesics or anti-allergic drugs have been used within 3 days before enrollment;
- Women of childbearing age are pregnant ( Positive urine pregnancy test), breastfeeding or planning to prepare for pregnancy within six months; 13. \ Hypertension that cannot be controlled by medication, such as systolic...
The study team makes the final eligibility decision.
Where it's taking place
- Chengdu, Sichuan, 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, 2 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chengdu, Sichuan, 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.