A Clinical Trial to Observe the Safety of 23-Valent Pneumococcal Polysaccharide Vaccine in Target Population
Completed
- Conditions
- Pneumococcal Infectious Disease
- Interventions
- Registration Number
- NCT07071701
- Lead Sponsor
- Sinovac Biotech Co., Ltd
- Brief Summary
An open clinical trial of a 23-valent pneumococcal polysaccharide vaccine (PPV23) developed by Sinovac Life Science Co., Ltd was conducted to evaluate the safety of Sinovac PPV23 in target population of individuals aged 2 years and above. All participants received 1 dose of PPV23 and self-selected whether to receive 1 dose of influenza vaccine at the same time.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19267
Inclusion Criteria
- Have voluntarily and at their own expense received the 23-valent pneumococcal polysaccharide vaccine;
- Participants and/or their guardians are able to understand and voluntarily participate in this study and sign an informed consent form;
- Provide valid legal identification.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Acitive safety surveillance group 23-valent pneumococcal polysaccharide vaccine - Acitive safety surveillance group Influenza vaccine - Passive safety surveillance group 23-valent pneumococcal polysaccharide vaccine - Passive safety surveillance group Influenza vaccine -
- Primary Outcome Measures
Name Time Method Incidence of adverse reactions to 23-valent pneumonia vaccine within 0-28 days after single and combined vaccination. 28 days after the vaccination
- Secondary Outcome Measures
Name Time Method Incidence of adverse events to 23-valent pneumonia vaccine within 0-28 days after single and combined vaccination. 28 days after the vaccination Incidence of adverse events to 23-valent pneumonia vaccine within 0-7 days after single and combined vaccination. 7 days after the vaccination
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of PPV23 in preventing pneumococcal infections in adults and children aged 2 years and above?
How does the safety profile of Sinovac's PPV23 compare to other 23-valent pneumococcal vaccines in post-marketing surveillance?
What biomarkers correlate with immune response to 23-valent pneumococcal polysaccharide vaccines in pediatric and adult populations?
Are there specific adverse event management strategies for PPV23 co-administration with influenza vaccines in clinical practice?
What is the comparative effectiveness of Sinovac PPV23 versus standard-of-care pneumococcal vaccines in preventing invasive pneumococcal disease?
Trial Locations
- Locations (1)
Jiangsu Provincial Center for Disease Prevention and Control
🇨🇳Nanjing, Jiangsu, China
Jiangsu Provincial Center for Disease Prevention and Control🇨🇳Nanjing, Jiangsu, China