Phase I Study of a Combined Vaccine for Diphtheria, Tetanus, Pertussis, Haemophilus Influenzae Type B, and Meningococcal Disease in Children Aged 2 Months to 6 Years

What this Trial Is About

Researchers are evaluating the safety and immune response of a combined vaccine that includes components for Diphtheria, Tetanus, Acellular Pertussis, Haemophilus influenzae type b, and Meningococcal group ACYW135 in children aged 2 months to 6 years. This Phase I clinical trial includes two parts Part One uses a randomized, partially blinded, dose-escalation and partially active-controlled design, while Part Two is a randomized, blinded, placebo-controlled study focusing on 2-month-old participants. The study involves multiple vaccine dosing schedules depending on the participants age group. Some groups receive a single dose of the combined vaccine on Day 0, while others receive three doses at 0, 2, and 4 months, followed by a booster dose between 18 and 24 months of age. The trial compares different dose levels, age groups, and also includes active comparator vaccines and placebo groups. Participants will undergo monitoring for adverse reactions within 14 days after each dose, with additional safety assessments extending up to 180 days for serious events. Researchers will evaluate immune responses by measuring specific antibodies against meningococcal groups and other vaccine components at various timepoints, including before and after booster doses. The total participation duration and detailed follow-up visits are designed to assess both safety and immunogenicity comprehensively.

Clinical Trial of the Adsorbed Acellular Pertussis (Tricomponent) DTaP-Haemophilus Influenzae Type b (Conjugate)-ACYW135 Group Meningococcal (Conjugate) Combined Vaccine