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

Phase 3

Recruiting

• Conditions: Pneumococcal Disease
• Interventions: Biological: control pneumococcal polysaccharide vaccine; Biological: 23-valent pneumococcal polysaccharide vaccine

• Registration Number: NCT06044077
• Lead Sponsor: Aimei Vacin BioPharm (Zhejiang) Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-09
• Study Start: 2023-09-08
• Study First Submitted: 2023-09-13
• Study First Submitted QC: 2023-09-19
• Last Update Submitted: 2023-09-19
• Study First Posted: 2023-09-21
• Last Update Posted: 2023-09-21
• Primary Completion: 2024-03-08
• Study Completion: 2029-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1920

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;

13. * 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	control pneumococcal polysaccharide vaccine	1 dose vaccination of control vaccine
Experimental Group	23-valent pneumococcal polysaccharide vaccine	1 dose vaccination of study vaccine

Primary Outcome Measures

Name	Time	Method
2-fold growth rate of IgG antibodies to 23 pneumococcal serotypes on 30 days after vaccination,	30 days	2-fold growth rate of IgG antibodies to 23 pneumococcal serotypes on 30 days after vaccination,
Incidence of adverse reactions/events on days 0 to 7 after vaccination	7 days	Incidence of adverse reactions/events on days 0 to 7 after vaccination
Geometric mean concentration (GMC) of IgG antibodies to 23 pneumococcal serotypes on 30 days after vaccination	30 days	Geometric mean concentration (GMC) of IgG antibodies to 23 pneumococcal serotypes on 30 days after vaccination
Incidence of adverse reactions/events within 30 minutes of vaccination	30 min after vaccination	Incidence of adverse reactions/events within 30 minutes of vaccination
Incidence of adverse reaction/event on days 0 to 30 after vaccination	30 days	Incidence of adverse reaction/event on days 0 to 30 after vaccination
Incidence of serious adverse events (SAE) within 6 months after vaccination	6 months	Incidence of serious adverse events (SAE) within 6 months after vaccination

Secondary Outcome Measures

Name	Time	Method
GMC of 23 pneumococcal serotype IgG antibodies in the 3rd and 6th year after vaccination	3, 6 years after vaccination	GMC of 23 pneumococcal serotype IgG antibodies in the 3rd and 6th year after vaccination
Geometric mean fold increase (GMFI) of IgG antibodies against 23 pneumococcal serotypes 30 days after vaccination	30 days	Geometric mean fold increase (GMFI) of IgG antibodies against 23 pneumococcal serotypes 30 days after vaccination

Trial Locations

Locations (1)

Sichuan Center For Disease Control and Prevention; 🇨🇳 Chengdu, Sichuan, China