Evaluating a Pneumococcal Vaccine in Healthy Individuals
Official title: 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
Run by Aimei Vacin BioPharm (Zhejiang) Co., Ltd. · NCT06044077 · Data updated 2026-11-12
This study is testing a new pneumococcal vaccine in healthy people aged 2 and older to see how well it works and if it's safe.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 2 Years and up |
| Sex | All |
| Enrollment | 1920 (estimated) |
| Sponsor | Aimei Vacin BioPharm (Zhejiang) Co., Ltd. Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Chengdu, Sichuan) |
| Status | Recruiting |
| Started | September 8, 2023 |
| Main results expected | March 8, 2024 |
| Study ends | July 31, 2029 |
| Registry record updated | September 21, 2023 |
| Trial ID | NCT06044077 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are healthy individuals aged 2 years and older who meet the eligibility criteria.
✕Probably not a fit
Patients who have previously received pneumococcal vaccines or have a history of culture-confirmed pneumococcal disease may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase 3 clinical trial is designed to assess the immunogenicity and safety of the 23-valent pneumococcal polysaccharide vaccine in healthy individuals aged 2 years and older. Participants will be randomly assigned to receive either the vaccine or a control vaccine, and their immune responses will be monitored. The study aims to provide insights into the vaccine's effectiveness in preventing pneumococcal disease. The trial will involve medical history evaluations and physical examinations to ensure participant eligibility.
Why it matters
Potential benefit: If successful, this study could enhance the prevention of pneumococcal disease in healthy populations through improved vaccination strategies.
How similar studies have gone: Other studies evaluating pneumococcal vaccines have shown positive outcomes, indicating that this approach is supported by previous research.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Healthy subjects 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; 2. Subjects who voluntarily participate and/or the subjects' legal guardians Or the entrusted person voluntarily agrees for his or her child to participate and signs an informed consent form (subjects aged 8-17 years old must also sign an informed notification form); 3. The subject and/or the subject's legal guardian or principal can abide by the clinical Relevant requirements of the research protocol; 4. \*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 have those conditions. Exclusion Criteria: 1. Previous vaccination with marketed or experimental pneumococcal vaccines; 2. Previous culture-confirmed history of invasive diseases caused by pneumococcal bacteria; 3. History or family history of convulsions, epilepsy, encephalopathy, and mental illness; 4. 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 hydrogen phosphate, and sodium chloride), and have a history of vaccination-related fever (39℃ or above ); 5. 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 syndrome); 6. 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, malignant tumors, severe skin diseases, etc.; 7. Known or suspected to be immune Academic functional defects include: immunosuppressant treatment (radiotherapy, chemotherapy, corticosteroids, antimetabolites, cytotoxic drugs), HIV infection, etc. within 6 months; 8. Have received any treatment within 3 months before enrollment Blood products or globulin treatment, those who have used hepatitis B immune globulin are acceptable; 9. Asplenia, functional asplenia or splenectomy; 10. \* 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; 11. \* Antipyretic analgesics or anti-allergic drugs have been used within 3 days before enrollment; 12. 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 blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg in adults aged 18 years and above before enrollment; 14\. \* Have received attenuated live vaccines within 14 days before vaccination, and received inactivated vaccines within 7 days; 15. Are participating in or plan to participate in clinical studies of other drugs or vaccines within 6 months after vaccination (immune persistence observation subjects in the vaccine who plan to vaccinate any marketed or unmarketed pneumococcal vaccine within 6 years after vaccination need to be excluded); 16. The investigators evaluate that they are not suitable for participating in the study. 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 have those conditions.
Where it's running
-
Sichuan Center For Disease Control and Prevention
Chengdu, Sichuan, China Recruiting
Study contacts
- Study coordinator: Xuecheng LIU
- Email: 534210793@qq.com
- Phone: +86 189 8195 8206
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Safety and immune response of three PG4 vaccine lots vs 20vPnC in adults
This study tests three different lots of a new pneumococcal vaccine and the standard 20vPnC vaccine in adults to see if they are similarly safe and provoke a similar immune response.
-
New pneumococcal vaccine safety and immune response in children and teens
This study tests whether a new pneumococcal vaccine is as safe and as effective as Prevnar 20 in children and adolescents who have previously received PCV.
-
New pneumococcal vaccine in infants shows safety and how it stacks up against Prevnar 20
A new pneumococcal vaccine is being tested in healthy infants to see if it is as safe as Prevnar 20 and whether it triggers a similar or better immune response.
-
New pneumococcal vaccine for healthy infants
A new pneumococcal vaccine is being tested in about 2-month-old healthy babies to see if it is as safe as Prevnar 20 and whether it may offer broader protection against germs that cause pneumonia, meningitis, and ear infections.
-
Serum collection after Gamma-PN vaccination to support assay development
This project will collect blood samples from people who receive the Gamma-PN vaccine to help develop lab tests for pneumococcal disease.
-
How pneumococcal conjugate vaccines may produce antibodies that protect against serogroup 33.
This will try two different pneumococcal conjugate vaccines in healthy adults to see which one makes antibodies that can kill serogroup 33 bacteria.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.