Last updated: September 19, 2023
Sponsor: Aimei Vacin BioPharm (Zhejiang) Co., Ltd.
Overall Status: Active - Recruiting
Phase
3
Condition
Pneumococcal Disease
Treatment
control pneumococcal polysaccharide vaccine
23-valent pneumococcal polysaccharide vaccine
Clinical Study ID
NCT06044077
AM2022PPV23III
Ages > 2 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Healthy subjects who meet the observation age of this clinical trial (2 years old andabove) and are determined based on medical history, physical examination and theresearcher's judgment;
- Subjects who voluntarily participate and/or the subjects' legal guardians Or theentrusted person voluntarily agrees for his or her child to participate and signs aninformed consent form (subjects aged 8-17 years old must also sign an informednotification form);
- The subject and/or the subject's legal guardian or principal can abide by the clinicalRelevant requirements of the research protocol;
- Axillary body temperature <37.3°C on the day of enrollment. For criteria marked withan asterisk (), if the subject has the conditions specified in the criterion, thevisit can be rescheduled when they no longer have those conditions.
Exclusion
Exclusion Criteria:
- Previous vaccination with marketed or experimental pneumococcal vaccines;
- Previous culture-confirmed history of invasive diseases caused by pneumococcalbacteria;
- History or family history of convulsions, epilepsy, encephalopathy, and mentalillness;
- Have a history of severe allergy to any vaccination or drug in the past, be allergicto the ingredients of the experimental vaccine (mainly including pneumococcalpolysaccharide, sodium dihydrogen phosphate, disodium hydrogen phosphate, and sodiumchloride), and have a history of vaccination-related fever (39℃ or above );
- Known severe congenital malformations, developmental disabilities or clinicallydiagnosed serious chronic diseases (such as Down syndrome, diabetes that cannot becontrolled 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, severecardiovascular diseases, severe liver and kidney diseases, malignant tumors, severeskin diseases, etc.;
- Known or suspected to be immune Academic functional defects include: immunosuppressanttreatment (radiotherapy, chemotherapy, corticosteroids, antimetabolites, cytotoxicdrugs), HIV infection, etc. within 6 months;
- Have received any treatment within 3 months before enrollment Blood products orglobulin 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 ofchronic disease within 3 days before enrollment, or need or plan to use intravenous ororal steroids within 1 month after vaccination;
- Antipyretic analgesics or anti-allergic drugs have been used within 3 days beforeenrollment;
- Women of childbearing age are pregnant ( Positive urine pregnancy test), breastfeedingor planning to prepare for pregnancy within six months; 13. *Hypertension that cannotbe controlled by medication, such as systolic blood pressure ≥ 160 mmHg and/ordiastolic blood pressure ≥ 100 mmHg in adults aged 18 years and above beforeenrollment;
- Have received attenuated live vaccines within 14 days before vaccination, andreceived inactivated vaccines within 7 days; 15. Are participating in or plan toparticipate in clinical studies of other drugs or vaccines within 6 months aftervaccination (immune persistence observation subjects in the vaccine who plan to vaccinateany marketed or unmarketed pneumococcal vaccine within 6 years after vaccination need to beexcluded); 16. The investigators evaluate that they are not suitable for participating inthe study. For criteria marked with an asterisk (*), if the subject has the conditions specified inthe criterion, the visit can be rescheduled when they no longer have those conditions.
Study Design
Total Participants: 1920
Treatment Group(s): 2
Primary Treatment: control pneumococcal polysaccharide vaccine
Phase: 3
Study Start date:
September 08, 2023
Estimated Completion Date:
July 31, 2029
Connect with a study center
Sichuan Center For Disease Control and Prevention
Chengdu, Sichuan
ChinaActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.