A Randomized, Blinded, Dose-Exploratory, Positive-Control Clinical Trial Evaluating the Safety and Immunogenicity of the 24-Valent Pneumococcal Polysaccharide Conjugate Vaccine (CRM197/Tetanus Toxoid) Following Administration in Individuals Aged 2 Months (Minimum 6 Weeks) and Older
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:
• 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
⁃ Phase II (age ≥50 group):
• People aged 50 and older who are willing to provide identification documents
• The trial participants voluntarily signed the informed consent form after providing their informed consent
• People aged 50 and older who have not received a pneumonia vaccine in the past five years
⁃ Phase II (2-month-old group (minimum 6 weeks)):
• Individuals aged 2 months or older (minimum 6 weeks) who are willing to provide identification documents
• The guardian (authorized representative) of the trial participant has voluntarily signed the informed consent form after providing informed consent.
• Infants aged 2 months (minimum 6 weeks) who have not previously received a pneumococcal vaccine