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

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ClinicalTrials.gov Identifier: NCT06044077
Recruitment Status : Recruiting
First Posted : September 21, 2023
Last Update Posted : September 21, 2023
Sponsor:
Information provided by (Responsible Party):
Aimei Vacin BioPharm (Zhejiang) Co., Ltd.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pneumococcal Disease Biological: 23-valent pneumococcal polysaccharide vaccine Biological: control pneumococcal polysaccharide vaccine Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1920 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : September 8, 2023
Estimated Primary Completion Date : March 8, 2024
Estimated Study Completion Date : July 31, 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental Group
1 dose vaccination of study vaccine
 Biological: 23-valent pneumococcal polysaccharide vaccine
23-valent pneumococcal polysaccharide vaccine from Aimei Vacin BioPharm (Zhejiang) Co., Ltd.
Control Group
1 dose vaccination of control vaccine
 Biological: control pneumococcal polysaccharide vaccine
23-valent pneumococcal polysaccharide vaccine from Merck Sharp & Dohme Corp


Outcome Measures
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Primary Outcome Measures :
  1. 2-fold growth rate of IgG antibodies to 23 pneumococcal serotypes on 30 days after vaccination, [ Time Frame: 30 days ]
    2-fold growth rate of IgG antibodies to 23 pneumococcal serotypes on 30 days after vaccination,

  2. Geometric mean concentration (GMC) of IgG antibodies to 23 pneumococcal serotypes on 30 days after vaccination [ Time Frame: 30 days ]
    Geometric mean concentration (GMC) of IgG antibodies to 23 pneumococcal serotypes on 30 days after vaccination

  3. Incidence of adverse reactions/events within 30 minutes of vaccination [ Time Frame: 30 min after vaccination ]
    Incidence of adverse reactions/events within 30 minutes of vaccination

  4. Incidence of adverse reactions/events on days 0 to 7 after vaccination [ Time Frame: 7 days ]
    Incidence of adverse reactions/events on days 0 to 7 after vaccination

  5. Incidence of adverse reaction/event on days 0 to 30 after vaccination [ Time Frame: 30 days ]
    Incidence of adverse reaction/event on days 0 to 30 after vaccination

  6. Incidence of serious adverse events (SAE) within 6 months after vaccination [ Time Frame: 6 months ]
    Incidence of serious adverse events (SAE) within 6 months after vaccination


Secondary Outcome Measures :
  1. Geometric mean fold increase (GMFI) of IgG antibodies against 23 pneumococcal serotypes 30 days after vaccination [ Time Frame: 30 days ]
    Geometric mean fold increase (GMFI) of IgG antibodies against 23 pneumococcal serotypes 30 days after vaccination

  2. GMC of 23 pneumococcal serotype IgG antibodies in the 3rd and 6th year after vaccination [ Time Frame: 3, 6 years after vaccination ]
    GMC of 23 pneumococcal serotype IgG antibodies in the 3rd and 6th year after vaccination


Other Outcome Measures:
  1. The proportion of subjects with ≥0.35ug/mL IgG antibodies to 23 pneumococcal serotypes 30 days after vaccination, [ Time Frame: 30 days ]
    The proportion of subjects with ≥0.35ug/mL IgG antibodies to 23 pneumococcal serotypes 30 days after vaccination,


Eligibility Criteria
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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06044077


Contacts
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Contact: Xuecheng LIU +86 189 8195 8206 534210793@qq.com

Locations
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China, Sichuan
Sichuan Center For Disease Control and Prevention Recruiting
Chengdu, Sichuan, China
Contact: Xuecheng LIU    +8618981958206      
Sponsors and Collaborators
Aimei Vacin BioPharm (Zhejiang) Co., Ltd.
More Information
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Responsible Party: Aimei Vacin BioPharm (Zhejiang) Co., Ltd.
ClinicalTrials.gov Identifier: NCT06044077    
Other Study ID Numbers: AM2022PPV23III
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: September 21, 2023
Last Verified: September 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
 Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs