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.
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
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)
Parallel
24-valent pneumococcal polysaccharide conjugate vaccine (CRM197/tetanus toxoid) (referred to as PCV24) (dose M)
Biological/Vaccine1 dose ( 0.5ml) of PCV24 vaccine (dose M)
PCV24 vaccine (dose H)
Biological/Vaccine1 dose ( 0.5ml) of PCV24 vaccine (dose H)
PCV24 vaccine (dose M)
Biological/Vaccine1 dose ( 0.5ml) of PCV24 vaccine (dose M)
23-valent pneumococcal polysaccharide vaccine (referred to as PPV23)
Biological/Vaccine1 dose ( 0.5ml) of PPV23 vaccine
PCV24 vaccine (dose M)
Biological/Vaccine1 dose ( 0.5ml) of PCV24 vaccine (dose M)
13-valent pneumococcal polysaccharide conjugate vaccine (referred to as PCV13)
Biological/Vaccine1 dose ( 0.5ml) of PCV13 vaccine
PCV24 vaccine (dose H)
Biological/Vaccine1 dose ( 0.5ml) of PCV24 vaccine (dose H)
PPV23 vaccine
Biological/Vaccine1 dose ( 0.5ml) of PPV23 vaccine
PCV24 vaccine (dose H)
Biological/Vaccine1 dose ( 0.5ml) of PCV24 vaccine (dose H)
PCV13 vaccine
Biological/Vaccine1 dose ( 0.5ml) of PCV13 vaccine
PCV24 vaccine (dose M)
Biological/VaccineIf trial participants are 12-23 months of age, they should receive 2 doses (0.5ml) of PCV24 ( dose M) , administered two months apart. If trial participants are 7-11 months of age, they should receive 2 doses ( 0.5ml) of PCV24 ( dose M) as a primary series, administered two months apart; a booster dose should be administered at 12-15 months of age, at least two months after the second dose.
PCV13 vaccine
Biological/VaccineIf trial participants are 12-23 months of age, they should receive 2 doses (0.5ml) of PCV13, administered two months apart. If trial participants are 7-11 months of age, they should receive 2 doses ( 0.5ml) of PCV13 as a primary series, administered two months apart; a booster dose should be administered at 12-15 months of age, at least two months after the second dose.
PCV24 vaccine (dose H)
Biological/VaccineIf trial participants are 12-23 months of age, they should receive 2 doses ( 0.5ml) of PCV24 (dose H) , administered two months apart. If trial participants are 7-11 months of age, they should receive 2 doses ( 0.5ml) of PCV24 ( dose H) as a primary series, administered two months apart; a booster dose should be administered at 12-15 months of age, at least two months after the second dose.
PCV13 vaccine
Biological/VaccineIf trial participants are 12-23 months of age, they should receive 2 doses ( 0.5ml) of PCV13 , administered two months apart. If trial participants are 7-11 months of age, they should receive 2 doses ( 0.5ml) of PCV13 as a primary series, administered two months apart; a booster dose should be administered at 12-15 months of age, at least two months after the second dose.
PCV24 vaccine (dose L)
Biological/VaccineThe primary vaccination series consists of 3 doses ( 0.5ml) of the PCV24 vaccine ( dose L) , administered 2 months apart; a single booster dose is administered at 12 to 15 months of age.
PCV13 vaccine
Biological/VaccineThe primary vaccination series consists of 3 doses ( 0.5ml) of the PCV13 vaccine, administered 2 months apart; a single booster dose is administered at 12 to 15 months of age.
PCV24 vaccine (dose M)
Biological/VaccineThe primary vaccination series consists of 3 doses of the PCV24 vaccine ( 0.5ml) , administered 2 months apart; a single booster dose is administered at 12 to 15 months of age.
PCV13 vaccine
Biological/VaccineThe primary vaccination series consists of 3 doses of the PCV13 vaccine ( 0.5ml) , administered 2 months apart; a single booster dose is administered at 12 to 15 months of age.
PCV24 vaccine (dose H)
Biological/VaccineThe primary vaccination series consists of 3 doses of the PCV24 vaccine ( 0.5ml) , administered 2 months apart; a single booster dose is administered at 12 to 15 months of age.
PCV13 vaccine
Biological/VaccineThe primary vaccination series consists of 3 doses of the PCV13 vaccine ( 0.5ml) , administered 2 months apart; a single booster dose is administered at 12 to 15 months of age.
PCV24 vaccine (dose L or M or H)
Biological/Vaccine1 dose ( 0.5ml) of PCV24 vaccine (dose L or M or H)
PPV23 vaccine
Biological/Vaccine1 dose ( 0.5ml) of PPV23 vaccine
PCV24 vaccine (dose L or M or H)
Biological/VaccineA primary vaccination series consisting of 3 doses of the PCV24 vaccine ( 0.5ml) , with a 2-month interval between each dose; a single booster dose should be administered at 12 to 15 months of age.
PCV13 vaccine
Biological/VaccineA primary vaccination series consisting of 3 doses of the PCV13 vaccine ( 0.5ml) , with a 2-month interval between each dose; a single booster dose should be administered at 12 to 15 months of age.
24
Treatment groupsSee each treatment group below.
Phase I: Incidence of adverse reactions
Phase I: Incidence of adverse reactions
Phase I: Incidence of serious adverse event (SAE)
Phase I: Incidence of abnormalities in urinalysis
Phase I: Incidence of adverse reactions
Phase I (2-month-old group [minimum 6 weeks]): Positive rate of vaccine-serotype-specific pneumococcal IgG antibodies (antibody concentration ≥ 0.35 μg/ml)
Phase I (2-month-old group [minimum 6 weeks]): Proportion with vaccine-serotype-specific pneumococcal IgG antibody concentrations ≥ 1.0 μg/ml
Phase I (2-month-old group [minimum 6 weeks]): GMC of serotype-specific pneumococcal IgG antibodies
Click on the lead sponsor to view all of their trials.
