Actively Recruiting
A Randomized, Blinded, Parallel Controlled Phase 3 Trial to Evaluate the Immunogenicity and Safety of the 23-valent Pneumococcal Polysaccharide Vaccine in Healthy People Aged 2 Years and Above
Led by Aimei Vacin BioPharm (Zhejiang) Co., Ltd. · Updated on 2023-09-21
1920
Participants Needed
1
Research Sites
281 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the immunogenicity and safety of the 23-valent pneumococcal polysaccharide vaccine in healthy individuals aged 2 years and older. This phase 3 clinical trial is randomized, blinded, and parallel controlled to compare the immune response and safety profile of the study vaccine against a control vaccine. The study focuses on measuring antibody responses and monitoring adverse reactions following vaccination. Participants will receive a single dose of either the 23-valent pneumococcal polysaccharide vaccine from Aimei Vacin BioPharm or a control pneumococcal polysaccharide vaccine from Merck Sharp & Dohme Corp. The study is designed with two groups, and both vaccines are administered as one dose. The trial includes detailed safety monitoring periods immediately after vaccination and over several months to assess adverse events. During the study, participants will undergo evaluations of their antibody levels against 23 pneumococcal serotypes 30 days after vaccination, with follow-up measurements at 3 and 6 years. Researchers will also track the incidence of adverse reactions within 30 minutes, 7 days, 30 days, and serious adverse events up to 6 months after vaccination. The total duration of participation includes initial vaccination and long-term follow-up for safety and immune response assessment.
CONDITIONS
Brief Title
A Clinical Trial to Evaluate the Immunogenicity and Safety of the 23-valent Pneumococcal Polysaccharide Vaccine in Healthy People
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy individuals aged 2 years and older based on medical history, physical exam, and investigator judgment
- Voluntary participation with signed informed consent (subjects aged 8-17 also must sign an assent form)
- Ability to follow study protocol requirements
- Axillary body temperature below 37.3°C on the day of enrollment; visit may be rescheduled if fever or other conditions present
You will not qualify if you...
- Previous vaccination with any pneumococcal vaccine (marketed or experimental)
- History of invasive pneumococcal disease confirmed by culture
- Personal or family history of convulsions, epilepsy, encephalopathy, or mental illness
- Severe allergy to vaccines or vaccine ingredients, or history of high fever (≥39°C) after vaccination
- Known severe congenital malformations, developmental disabilities, or serious chronic diseases
- Known or suspected serious diseases such as severe respiratory, digestive, endocrine, cardiovascular, liver, kidney, malignancies, or severe skin diseases
- Immune deficiencies or immunosuppressive treatment within 6 months
- Blood product or immune globulin treatment within 3 months before enrollment
- Asplenia, functional asplenia, or splenectomy
- Acute infection or exacerbation of chronic disease within 3 days before enrollment, or planned steroid use within 1 month after vaccination
- Recent use of antipyretic, analgesic, or anti-allergic drugs within 3 days before enrollment
- Pregnancy, breastfeeding, or planning pregnancy within 6 months
- Uncontrolled hypertension (systolic ≥160 mmHg or diastolic ≥100 mmHg) in adults
- Recent live vaccine within 14 days or inactivated vaccine within 7 days before vaccination
- Participation in other drug or vaccine clinical trials within 6 months after vaccination
- Investigator judgment deeming participant unsuitable for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive a single dose of either the study vaccine or the control vaccine.
1 vaccination visit (in-person)
Duration - 6 months
Participants are monitored for adverse reactions up to 30 days after vaccination and serious adverse events up to 6 months after vaccination.
Multiple visits including visits at 30 minutes, 7 days, 30 days, and periodic assessments up to 6 months after vaccination
Duration - Up to 6 years
Participants have antibody levels checked in the 3rd and 6th year after vaccination to assess long-term immune response.
2 visits (at 3 years and 6 years post-vaccination)
Trial Site Locations
Total: 1 location
1
Sichuan Center For Disease Control and Prevention
Chengdu, Sichuan, China
Actively Recruiting
Research Team
X
Xuecheng LIU
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here