Actively Recruiting
PCV24 Clinical Trial in Infants and Young Children Aged 2 Months (Minimum 6 Weeks) to 71 Months
Led by Shanghai Reinovax Biologics Co.,LTD · Updated on 2026-01-16
480
Participants Needed
7
Research Sites
98 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The Phase II clinical trial of the 24-valent pneumococcal polysaccharide conjugate vaccine (RZ700) will be carried out in infants and young children aged 2 months (minimum 6 weeks) to 71 months. The purpose of this study is to evaluate the immunogenicity and safety of the 24-valent pneumococcal polysaccharide conjugate vaccine.
CONDITIONS
Official Title
PCV24 Clinical Trial in Infants and Young Children Aged 2 Months (Minimum 6 Weeks) to 71 Months
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy children aged 2 months (minimum 6 weeks) to 71 months
- Guardians can provide valid ID for both child and themselves and proof of guardianship
- Guardians voluntarily agree to participation and sign consent form
- Guardians can understand trial procedures (not illiterate)
You will not qualify if you...
- Prior or planned pneumococcal vaccination or history of invasive pneumococcal disease
- Clinically significant abnormal physical exam
- Fever (axillary temperature 65 37.5�b0C) within 3 days before enrollment or day before first vaccine dose
- Recent acute illness, antibiotic or antiviral use within 3 days before first dose
- Allergy to vaccine components or history of severe allergic reactions to vaccines or drugs
- Receipt of certain vaccines within 7 or 14 days prior to enrollment
- Use of investigational drugs or blood products within 3 months prior or planned during trial
- History of blood disorders or anticoagulant therapy
- Known infectious diseases like tuberculosis, hepatitis B/C, or HIV
- Severe chronic diseases or unstable progressive conditions
- Abnormal birth history or weight in infants 2 to 11 months
- Severe eczema or jaundice in infants 2 to 11 months
- Severe congenital malformations, developmental disorders, genetic defects, or malnutrition
- Neurological or neurodevelopmental disorders or family history of mental illness
- History of immunodeficiency, immunosuppression, autoimmune diseases, or recent immunomodulatory therapy
- Asplenia or related conditions
- Guardians unable to comply with trial requirements or planning to relocate
- Other factors deemed unsuitable by researchers
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 7 locations
1
Luzhou District Center for Disease Control and Prevention
Changzhi, Shanxi, China, 046011
Actively Recruiting
2
Qinxian County Center for Disease Control and Prevention
Changzhi, Shanxi, China, 046400
Actively Recruiting
3
Kuangqu District Center for Disease Control and Prevention of Yangquan City
Yangquan, Shanxi, China, 045000
Actively Recruiting
4
Xinjiang County Center for Disease Control and Prevention
Yuncheng, Shanxi, China, 043100
Actively Recruiting
5
Jishan County Center for Disease Control and Prevention
Yuncheng, Shanxi, China, 043200
Actively Recruiting
6
Yongji City Center for Disease Control and Prevention
Yuncheng, Shanxi, China, 044500
Actively Recruiting
7
Shangdang District Center for Disease Control and Prevention of Changzhi City
Yuncheng, Shanxi, China, 047100
Actively Recruiting
Research Team
P
Principal Investigator ，Yunong Zhang，Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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