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A Clinical Trial to Evaluate the Immunogenicity and Safety of the 23-valent Pneumococcal Polysaccharide Vaccine in Healthy People | Clinical Trials | Clareo Health

RECRUITINGPHASE3

A Clinical Trial to Evaluate the Immunogenicity and Safety of the 23-valent Pneumococcal Polysaccharide Vaccine in Healthy People

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

NCT06044077•Aimei Vacin BioPharm (Zhejiang) Co., Ltd.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

2 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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;
+4 more criteria

Locations (1)

Sichuan Center For Disease Control and Prevention

Chengdu, Sichuan, China

Key Dates

Start Date

September 8, 2023

Primary Completion Date

March 8, 2024

Completion Date

July 31, 2029

Last Updated

September 21, 2023

Enrollment

1,920

ESTIMATED participants

Conditions

Pneumococcal Disease

Interventions

23-valent pneumococcal polysaccharide vaccine

BIOLOGICAL

control pneumococcal polysaccharide vaccine

BIOLOGICAL

Contacts

Xuecheng LIU

CONTACT

+86 189 8195 8206 534210793@qq.com

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ACTIVE_NOT_RECRUITINGPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 21, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Clinical Trial to Evaluate the Immunogenicity and Safety of the 23-valent Pneumococcal Polysaccharide Vaccine in Healthy People

Inclusion Criteria

Exclusion Criteria

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Phase 2 Trial to Evaluate Safety and Immunogenicity of Inventprise's (IVT) 25-valent Pneumococcal Conjugate Vaccine (IVT PCV-25) in Healthy Infants

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