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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date  ICMJE September 13, 2023
First Posted Date  ICMJE September 21, 2023
Last Update Posted Date September 21, 2023
Actual Study Start Date  ICMJE September 8, 2023
Estimated Primary Completion Date March 8, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 19, 2023)
  • 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,
  • 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
  • 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
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2023)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 19, 2023)		 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,
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Clinical Trial to Evaluate the Immunogenicity and Safety of the 23-valent Pneumococcal Polysaccharide Vaccine in Healthy People
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Pneumococcal Disease
Intervention  ICMJE
  • Biological: 23-valent pneumococcal polysaccharide vaccine
    23-valent pneumococcal polysaccharide vaccine from Aimei Vacin BioPharm (Zhejiang) Co., Ltd.
  • Biological: control pneumococcal polysaccharide vaccine
    23-valent pneumococcal polysaccharide vaccine from Merck Sharp & Dohme Corp
Study Arms  ICMJE
  • Experimental: Experimental Group
    1 dose vaccination of study vaccine
    Intervention: Biological: 23-valent pneumococcal polysaccharide vaccine
  • Control Group
    1 dose vaccination of control vaccine
    Intervention: Biological: control pneumococcal polysaccharide vaccine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 19, 2023)		 1920
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2029
Estimated Primary Completion Date March 8, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Xuecheng LIU +86 189 8195 8206 534210793@qq.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06044077
Other Study ID Numbers  ICMJE AM2022PPV23III
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Aimei Vacin BioPharm (Zhejiang) Co., Ltd.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Aimei Vacin BioPharm (Zhejiang) Co., Ltd.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Aimei Vacin BioPharm (Zhejiang) Co., Ltd.
Verification Date September 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP