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.
Age range
6 Weeks
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Phase I: Incidence of adverse reactions
Timeframe: Within 7 days of receiving each dose of the vaccine
Phase I: Incidence of adverse reactions
Timeframe: Within 30 days of receiving each dose of the vaccine
Phase I: Incidence of serious adverse event (SAE)
Timeframe: 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
Timeframe: 4 days after vaccination
Phase I: Incidence of abnormalities in complete blood count
Timeframe: 4 days after vaccination
Phase I: Incidence of abnormalities in blood chemistry
Timeframe: 4 days after vaccination
Phase I: Incidence of abnormalities in coagulation function
Timeframe: 4 days after vaccination
Phase II (≥50 years old group): Geometric mean concentration (GMC) of serotype-specific pneumococcal IgG antibodies
Timeframe: 30 days after vaccination
Phase II (≥50 years old group): ≥4-fold increase of serotype-specific pneumococcal IgG antibodies
Timeframe: 30 days after vaccination
Phase II (≥50 years old group): Geometric mean increment (GMI) of serotype-specific pneumococcal IgG antibodies
Timeframe: 30 days after vaccination
Phase II (≥50 years old group): Serotype-specific pneumococcal OPA antibody titers in some trial participants
Timeframe: 30 days after vaccination
Phase II (≥50 years old group): Proportion of trial participants with serotype-specific pneumococcal OPA antibody titers ≥1:8
Timeframe: 30 days after vaccination
Phase II (≥50 years old group): Incidence of adverse reactions
Timeframe: Within 7 days of vaccination
Phase II (≥50 years old group): Incidence of adverse reactions
Timeframe: 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)
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: Within 7 days of each dose
Phase II (2-month-old group [minimum 6 weeks]): Incidence of adverse reactions
Timeframe: Within 30 days of each dose