Safety and Immune Response Study of a 24-Valent Pneumococcal Conjugate Vaccine CRM197Tetanus Toxoid in People Starting at 2 Months Old

What this Trial Is About

Researchers are evaluating the safety and immune response of a 24-valent pneumococcal polysaccharide conjugate vaccine CRM197tetanus toxoid in individuals aged 2 months minimum 6 weeks and older. This clinical trial includes Phase I and Phase II parts, with participants divided into various age groups. The study uses randomized, blinded, and dose-escalation designs with positive controls to understand how the vaccine performs across ages from infants to older adults. The trial involves multiple vaccine doses and dose levels low, medium, high depending on age group and phase. Infants receive a primary vaccination series of three doses spaced two months apart, plus a booster dose between 12 and 15 months. Older children and adults receive one dose of the study vaccine or comparator vaccines, with random assignment to different dose groups. The study evaluates several vaccine types, including PCV24 at various doses, PPV23, and PCV13. Participants undergo screening and vaccination visits, with monitoring for adverse reactions within 7 and 30 days after each dose. Blood tests and urinalysis are performed shortly after vaccination to assess safety. Researchers measure immune responses by analyzing pneumococcal antibody levels at multiple time points, including after the primary series and booster doses. The study includes follow-up for serious adverse events up to 180 days after vaccination. Total participation duration varies by age group and dose schedule.

Clinical Trial of the 24-valent Pneumococcal Polysaccharide Conjugate Vaccine (CRM197/Tetanus Toxoid)