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

Primary Purpose

Pneumococcal Disease

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
23-valent pneumococcal polysaccharide vaccine
control pneumococcal polysaccharide vaccine
Sponsored by
Aimei Vacin BioPharm (Zhejiang) Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pneumococcal Disease

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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; 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); The subject and/or the subject's legal guardian or principal can abide by the clinical Relevant requirements of the research protocol; *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: Previous vaccination with marketed or experimental pneumococcal vaccines; Previous culture-confirmed history of invasive diseases caused by pneumococcal bacteria; History or family history of convulsions, epilepsy, encephalopathy, and mental illness; 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 ); 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); 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.; Known or suspected to be immune Academic functional defects include: immunosuppressant treatment (radiotherapy, chemotherapy, corticosteroids, antimetabolites, cytotoxic drugs), HIV infection, etc. within 6 months; Have received any treatment within 3 months before enrollment Blood products or globulin treatment, those who have used hepatitis B immune globulin are acceptable; Asplenia, functional asplenia or splenectomy; * 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; * Antipyretic analgesics or anti-allergic drugs have been used within 3 days before enrollment; 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.

Sites / Locations

  • Sichuan Center For Disease Control and PreventionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Experimental Group

Control Group

Arm Description

1 dose vaccination of study vaccine

1 dose vaccination of control vaccine

Outcomes

Primary Outcome Measures

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,
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
Incidence of adverse reactions/events within 30 minutes of vaccination
Incidence of adverse reactions/events within 30 minutes of vaccination
Incidence of adverse reactions/events on days 0 to 7 after vaccination
Incidence of adverse reactions/events on days 0 to 7 after vaccination
Incidence of adverse reaction/event on days 0 to 30 after vaccination
Incidence of adverse reaction/event on days 0 to 30 after vaccination
Incidence of serious adverse events (SAE) within 6 months after vaccination
Incidence of serious adverse events (SAE) within 6 months after vaccination

Secondary Outcome Measures

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
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

Full Information

First Posted
September 13, 2023
Last Updated
September 19, 2023
Sponsor
Aimei Vacin BioPharm (Zhejiang) Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT06044077
Brief Title
A Clinical Trial to Evaluate the Immunogenicity and Safety of the 23-valent Pneumococcal Polysaccharide Vaccine in Healthy People
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 8, 2023 (Actual)
Primary Completion Date
March 8, 2024 (Anticipated)
Study Completion Date
July 31, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aimei Vacin BioPharm (Zhejiang) Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumococcal Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1920 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
1 dose vaccination of study vaccine
Arm Title
Control Group
Arm Type
Other
Arm Description
1 dose vaccination of control vaccine
Intervention Type
Biological
Intervention Name(s)
23-valent pneumococcal polysaccharide vaccine
Intervention Description
23-valent pneumococcal polysaccharide vaccine from Aimei Vacin BioPharm (Zhejiang) Co., Ltd.
Intervention Type
Biological
Intervention Name(s)
control pneumococcal polysaccharide vaccine
Intervention Description
23-valent pneumococcal polysaccharide vaccine from Merck Sharp & Dohme Corp
Primary Outcome Measure Information:
Title
2-fold growth rate of IgG antibodies to 23 pneumococcal serotypes on 30 days after vaccination,
Description
2-fold growth rate of IgG antibodies to 23 pneumococcal serotypes on 30 days after vaccination,
Time Frame
30 days
Title
Geometric mean concentration (GMC) of IgG antibodies to 23 pneumococcal serotypes on 30 days after vaccination
Description
Geometric mean concentration (GMC) of IgG antibodies to 23 pneumococcal serotypes on 30 days after vaccination
Time Frame
30 days
Title
Incidence of adverse reactions/events within 30 minutes of vaccination
Description
Incidence of adverse reactions/events within 30 minutes of vaccination
Time Frame
30 min after vaccination
Title
Incidence of adverse reactions/events on days 0 to 7 after vaccination
Description
Incidence of adverse reactions/events on days 0 to 7 after vaccination
Time Frame
7 days
Title
Incidence of adverse reaction/event on days 0 to 30 after vaccination
Description
Incidence of adverse reaction/event on days 0 to 30 after vaccination
Time Frame
30 days
Title
Incidence of serious adverse events (SAE) within 6 months after vaccination
Description
Incidence of serious adverse events (SAE) within 6 months after vaccination
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Geometric mean fold increase (GMFI) of IgG antibodies against 23 pneumococcal serotypes 30 days after vaccination
Description
Geometric mean fold increase (GMFI) of IgG antibodies against 23 pneumococcal serotypes 30 days after vaccination
Time Frame
30 days
Title
GMC of 23 pneumococcal serotype IgG antibodies in the 3rd and 6th year after vaccination
Description
GMC of 23 pneumococcal serotype IgG antibodies in the 3rd and 6th year after vaccination
Time Frame
3, 6 years after vaccination
Other Pre-specified Outcome Measures:
Title
The proportion of subjects with ≥0.35ug/mL IgG antibodies to 23 pneumococcal serotypes 30 days after vaccination,
Description
The proportion of subjects with ≥0.35ug/mL IgG antibodies to 23 pneumococcal serotypes 30 days after vaccination,
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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; 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); The subject and/or the subject's legal guardian or principal can abide by the clinical Relevant requirements of the research protocol; *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: Previous vaccination with marketed or experimental pneumococcal vaccines; Previous culture-confirmed history of invasive diseases caused by pneumococcal bacteria; History or family history of convulsions, epilepsy, encephalopathy, and mental illness; 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 ); 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); 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.; Known or suspected to be immune Academic functional defects include: immunosuppressant treatment (radiotherapy, chemotherapy, corticosteroids, antimetabolites, cytotoxic drugs), HIV infection, etc. within 6 months; Have received any treatment within 3 months before enrollment Blood products or globulin treatment, those who have used hepatitis B immune globulin are acceptable; Asplenia, functional asplenia or splenectomy; * 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; * Antipyretic analgesics or anti-allergic drugs have been used within 3 days before enrollment; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xuecheng LIU
Phone
+86 189 8195 8206
Email
534210793@qq.com
Facility Information:
Facility Name
Sichuan Center For Disease Control and Prevention
City
Chengdu
State/Province
Sichuan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuecheng LIU
Phone
+8618981958206

12. IPD Sharing Statement

Learn more about this trial

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

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