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RecruitingNCT06044077Updated Sep 21, 2023

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

A Phase 3 interventional study of 23-valent pneumococcal polysaccharide vaccine and control pneumococcal polysaccharide vaccine in Pneumococcal Disease, sponsored by Aimei Vacin BioPharm (Zhejiang) Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 2 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-21.

Sponsored by Aimei Vacin BioPharm (Zhejiang) Co., Ltd. · Phase 3, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Mar 2024, 2 years 7 months ago, but the record still lists the study as recruiting.
  • Started Sep 2023; still recruiting 3 years 1 month later.
Phase
Phase 3
Study type
Interventional
Enrollment
1,920
Allocation
Randomized
Ages
2 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Pneumococcal Disease
03

In context

Pneumococcal Infections

281 studies on the registry are indexed under Pneumococcal Infections; 27 are open to participants now.

This study's planned enrollment of 1,920 is above the median of 379 across 230 interventional studies indexed under Pneumococcal Infections.

Browse Pneumococcal Infections studies →

Lead sponsor

Aimei Vacin BioPharm (Zhejiang) Co., Ltd. is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years and older
Sexes eligible
All
Accepts 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

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;
  1. * 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.

05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
1,920 participants (estimated)

Study arms

  • Experimental
    Experimental Group

    1 dose vaccination of study vaccine

    Biological: 23-valent pneumococcal polysaccharide vaccine

  • Other
    Control Group

    1 dose vaccination of control vaccine

    Biological: control pneumococcal polysaccharide vaccine

Interventions

  • Biological23-valent pneumococcal polysaccharide vaccine

    23-valent pneumococcal polysaccharide vaccine from Aimei Vacin BioPharm (Zhejiang) Co., Ltd.

  • Biologicalcontrol pneumococcal polysaccharide vaccine

    23-valent pneumococcal polysaccharide vaccine from Merck Sharp \& Dohme Corp

06

What researchers measure

Primary outcomes

  1. 2-fold growth rate of IgG antibodies to 23 pneumococcal serotypes on 30 days after vaccination,

    2-fold growth rate of IgG antibodies to 23 pneumococcal serotypes on 30 days after vaccination,

    Time frame: 30 days

  2. Geometric mean concentration (GMC) 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

  3. Incidence of adverse reactions/events within 30 minutes of vaccination

    Incidence of adverse reactions/events within 30 minutes of vaccination

    Time frame: 30 min after vaccination

  4. Incidence of adverse reactions/events on days 0 to 7 after vaccination

    Incidence of adverse reactions/events on days 0 to 7 after vaccination

    Time frame: 7 days

  5. Incidence of adverse reaction/event on days 0 to 30 after vaccination

    Incidence of adverse reaction/event on days 0 to 30 after vaccination

    Time frame: 30 days

  6. Incidence of serious adverse events (SAE) within 6 months after vaccination

    Incidence of serious adverse events (SAE) within 6 months after vaccination

    Time frame: 6 months

Secondary outcomes

  1. Geometric mean fold increase (GMFI) of IgG antibodies against 23 pneumococcal serotypes 30 days after vaccination

    Geometric mean fold increase (GMFI) of IgG antibodies against 23 pneumococcal serotypes 30 days after vaccination

    Time frame: 30 days

  2. GMC of 23 pneumococcal serotype IgG antibodies in the 3rd and 6th year after vaccination

    GMC of 23 pneumococcal serotype IgG antibodies in the 3rd and 6th year after vaccination

    Time frame: 3, 6 years after vaccination

Other outcomes

  1. The proportion of subjects with ≥0.35ug/mL IgG antibodies to 23 pneumococcal serotypes 30 days after vaccination,

    The proportion of subjects with ≥0.35ug/mL IgG antibodies to 23 pneumococcal serotypes 30 days after vaccination,

    Time frame: 30 days

07

Study locations

1 of 1 sites recruiting
  • Sichuan Center For Disease Control and Prevention
    Chengdu, Sichuan, China
    • Xuecheng LIU · Contact · +8618981958206
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06044077
Lead sponsor
Aimei Vacin BioPharm (Zhejiang) Co., Ltd.
Responsible party
Sponsor
First posted
Sep 21, 2023
Start date
Sep 8, 2023
Primary completion
Mar 8, 2024 (estimated)
Completion
Jul 31, 2029 (estimated)
Last update
Sep 21, 2023

Study contacts

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

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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