About this trial
This clinical trial consists of Phase I and Phase II. The objective is to evaluate the safety and immunogenicity of the 24-valent pneumococcal polysaccharide conjugate vaccine (CRM197/tetanus toxoid) in individuals aged 2 months (minimum 6 weeks) and older.
Eligibility criteria
Qualifiers
Individuals aged 2 months (minimum 6 weeks), 7 months to 5 years, and 18 years and older who are willing to provide identification
The trial participant and/or guardian (legal representative) has voluntarily signed the informed consent form after providing informed consent
Children aged 5 and under who have not previously received a pneumococcal vaccine
People aged 18 and older who have not received a pneumonia vaccine in the past five years
Disqualifiers
Preterm birth (delivery before 37 weeks of gestation), low birth weight (<2500 g at birth), history of labor abnormalities or resuscitation due to asphyxia; (Applicable to individuals in Phase I and Phase II who are 2 months of age or older (minimum 6 weeks))
Patients with abnormal results in pre-vaccination blood tests (including complete blood count, blood chemistry, and coagulation function) or urinalysis, which the investigator determines to be clinically significant; (Applicable only to Phase I participants aged 2 years (or 7 months) and older)
Individuals who are allergic to the active ingredient of the vaccine, any of its inactive ingredients, or substances used in the manufacturing process; or those who have previously experienced an allergic reaction after receiving a similar vaccine; Individuals with a history of severe allergic reactions to vaccines (such as acute allergic reactions, angioedema, or difficulty breathing), or a history of severe allergic reactions to any vaccine, food, or medication, including urticaria, anaphylactic shock, eczema, allergic respiratory distress, angioedema, or a history of asthma
Individuals with uncontrolled hypertension (as measured on-site: systolic blood pressure ≥160 mmHg and diastolic blood pressure ≥100 mmHg); (Applicable to Stage II participants aged 50 and older and Stage I participants aged 18 and older)
Trial design
Treatments tested in this trial
- 24-valent pneumococcal polysaccharide conjugate vaccine (CRM197/tetanus toxoid) (referred to as PCV24) (dose M)
- PCV24 vaccine (dose H)
- PCV24 vaccine (dose M)
- 23-valent pneumococcal polysaccharide vaccine (referred to as PPV23)
- PCV24 vaccine (dose M)
- 13-valent pneumococcal polysaccharide conjugate vaccine (referred to as PCV13)
- PCV24 vaccine (dose H)
- PPV23 vaccine
- PCV24 vaccine (dose H)
- PCV13 vaccine
- PCV24 vaccine (dose M)
- PCV13 vaccine
- PCV24 vaccine (dose H)
- PCV13 vaccine
- PCV24 vaccine (dose L)
- PCV13 vaccine
- PCV24 vaccine (dose M)
- PCV13 vaccine
- PCV24 vaccine (dose H)
- PCV13 vaccine
- PCV24 vaccine (dose L or M or H)
- PPV23 vaccine
- PCV24 vaccine (dose L or M or H)
- PCV13 vaccine
Treatment groups
24
Treatment groupsSee each treatment group below.