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.
Phase I employs a randomized, blinded, dose-escalation, positive-control design with a total sample size of 310 participants. The study population is divided into five age groups: the 18-49 age group is an open-label design with M and H dose groups; The 7-23-month, 2-5-year-old, and ≥50-year-old groups will use a positive-control, blinded design with M and H dose groups; the 2-month-old (minimum 6 weeks) group will use a positive-control, dose-escalation, and blinded design with L, M, and H dose groups. The Phase II study was divided into two age groups. The ≥50-year-old group: a randomized, blinded, active-controlled design with a total sample size of 160 participants, who were randomly assigned to the treatment and control groups in a 1:1 ratio; the 2-month-old (minimum 6 weeks) group: a randomized, blinded, active-controlled design with a total sample size of 384 participants. Participants were randomly assigned in a 3:1 ratio to the treatment groups (doses L, M, and H) and the control group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
854
1 dose ( 0.5ml) of PCV24 vaccine (dose M)
1 dose ( 0.5ml) of PCV24 vaccine (dose H)
1 dose ( 0.5ml) of PCV24 vaccine (dose M)
Ningling County Center for Disease Control and Prevention
Shangqiu, China
NOT_YET_RECRUITINGXiangcheng County Center for Disease Control and Prevention
Xuchang, China
RECRUITINGPhase I: Incidence of adverse reactions
Time frame: Within 7 days of receiving each dose of the vaccine
Phase I: Incidence of adverse reactions
Time frame: Within 30 days of receiving each dose of the vaccine
Phase I: Incidence of serious adverse event (SAE)
Time frame: Within 180 days of receiving the first dose of the vaccine through completion of the full vaccination series for each group
Phase I: Incidence of abnormalities in urinalysis
Time frame: 4 days after vaccination
Phase I: Incidence of abnormalities in complete blood count
Time frame: 4 days after vaccination
Phase I: Incidence of abnormalities in blood chemistry
Time frame: 4 days after vaccination
Phase I: Incidence of abnormalities in coagulation function
Time frame: 4 days after vaccination
Phase II (≥50 years old group): Geometric mean concentration (GMC) of serotype-specific pneumococcal IgG antibodies
Time frame: 30 days after vaccination
Phase II (≥50 years old group): ≥4-fold increase of serotype-specific pneumococcal IgG antibodies
Time frame: 30 days after vaccination
Phase II (≥50 years old group): Geometric mean increment (GMI) of serotype-specific pneumococcal IgG antibodies
Time frame: 30 days after vaccination
Phase II (≥50 years old group): Serotype-specific pneumococcal OPA antibody titers in some trial participants
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1 dose ( 0.5ml) of PPV23 vaccine
1 dose ( 0.5ml) of PCV24 vaccine (dose M)
1 dose ( 0.5ml) of PCV13 vaccine
1 dose ( 0.5ml) of PCV24 vaccine (dose H)
1 dose ( 0.5ml) of PPV23 vaccine
1 dose ( 0.5ml) of PCV24 vaccine (dose H)
1 dose ( 0.5ml) of PCV13 vaccine
If 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.
If 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.
If 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.
If 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.
The 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.
The 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.
The 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.
The 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.
The 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.
The 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.
1 dose ( 0.5ml) of PCV24 vaccine (dose L or M or H)
1 dose ( 0.5ml) of PPV23 vaccine
A 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.
A 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.
Time frame: 30 days after vaccination
Phase II (≥50 years old group): Proportion of trial participants with serotype-specific pneumococcal OPA antibody titers ≥1:8
Time frame: 30 days after vaccination
Phase II (≥50 years old group): Incidence of adverse reactions
Time frame: Within 7 days of vaccination
Phase II (≥50 years old group): Incidence of adverse reactions
Time frame: Within 30 days of vaccination
Phase II (2-month-old group [minimum 6 weeks]): Positive rate of vaccine-serotype-specific pneumococcal IgG antibodies (antibody concentration ≥ 0.35 μg/ml)
Time frame: 30 days after the primary series, before the booster dose, and 30 days after the booster dose
Phase II (2-month-old group [minimum 6 weeks]): Proportion with vaccine-serotype-specific pneumococcal IgG antibody concentrations ≥ 1.0 μg/ml
Time frame: 30 days after the primary series, before the booster dose, and 30 days after the booster dose
Phase II (2-month-old group [minimum 6 weeks]): GMC of serotype-specific pneumococcal IgG antibodies
Time frame: 30 days after the primary series, before the booster dose, and 30 days after the booster dose
Phase II (2-month-old group [minimum 6 weeks]): GMI of serotype-specific pneumococcal IgG antibodies
Time frame: 30 days after the primary series, before the booster dose, and 30 days after the booster dose
Phase II (2-month-old group [minimum 6 weeks]): Serotype-specific pneumococcal OPA antibody titers in some trial participants
Time frame: 30 days after the primary series; 30 days after the booster dose
Phase II (2-month-old group [minimum 6 weeks]): Proportion of trial participants with serotype-specific pneumococcal OPA antibody titers ≥1:8
Time frame: 30 days after the primary series; 30 days after the booster dose
Phase II (2-month-old group [minimum 6 weeks]): Incidence of adverse reactions
Time frame: Within 7 days of each dose
Phase II (2-month-old group [minimum 6 weeks]): Incidence of adverse reactions
Time frame: Within 30 days of each dose
Phase I: Incidence of adverse reactions
Time frame: Within 30 days of receiving each dose of the vaccine
Phase I (2-month-old group [minimum 6 weeks]): Positive rate of vaccine-serotype-specific pneumococcal IgG antibodies (antibody concentration ≥ 0.35 μg/ml)
Time frame: 30 days after the primary series, 30 and 180 days after the booster dose
Phase I (2-month-old group [minimum 6 weeks]): Proportion with vaccine-serotype-specific pneumococcal IgG antibody concentrations ≥ 1.0 μg/ml
Time frame: 30 days after the primary series, 30 and 180 days after the booster dose
Phase I (2-month-old group [minimum 6 weeks]): GMC of serotype-specific pneumococcal IgG antibodies
Time frame: 30 days after the primary series, 30 and 180 days after the booster dose
Phase I (2-month-old group [minimum 6 weeks]): GMI of serotype-specific pneumococcal IgG antibodies
Time frame: 30 days after the primary series, 30 and 180 days after the booster dose
Phase I (2-month-old group [minimum 6 weeks]): Serotype-specific pneumococcal OPA antibody titers
Time frame: 30 days after the primary series; 30 days after the booster dose
Phase I (2-month-old group [minimum 6 weeks]): Proportion of serotype-specific pneumococcal OPA antibody titers ≥1:8
Time frame: 30 days after the primary series; 30 days after the booster dose
Phase I (≥50 years old group): GMC of Serotype-specific pneumococcal IgG antibody
Time frame: 30 days after vaccination
Phase I (≥50 years old group): ≥4-fold increaseof Serotype-specific pneumococcal IgG antibody
Time frame: 30 days after vaccination
Phase I (≥50 years old group): GMI of Serotype-specific pneumococcal IgG antibody
Time frame: 30 days after vaccination
Phase I (≥50 years old group): Serotype-specific pneumococcal OPA antibody titers
Time frame: 30 days after vaccination
Phase I (≥50 years old group): Proportion of serotype-specific pneumococcal OPA antibody titers ≥1:8
Time frame: 30 days after vaccination
Phase II (≥50 years old group): Incidence of adverse reactions
Time frame: Within 30 days of vaccination
Phase II (≥50 years old group): Incidence of SAE
Time frame: Within 180 days of vaccination
Phase II (2-month-old group [minimum 6 weeks]): Incidence of adverse reactions
Time frame: Within 30 days of each dose
Phase II (2-month-old group [minimum 6 weeks]): Incidence of SAE
Time frame: Within 180 days of receiving the first dose of the vaccine through the booster shot