Emmy and Weixin's 13-valent pneumococcal vaccine enters Phase 3 clinical trials

TextPharmaceutical Guanlan

According to the China Drug Clinical Trial Registration and Information Publicity Platform, Emmy Weixin Biopharmaceutical (Zhejiang) Co.

Screenshot source: Drug Clinical Trial Registration and Information Publicity Platform

The 13-valent pneumococcal conjugate vaccine is mainly used in infants and children.

This time, a single-center, randomized, double-blind, parallel-group, non-inferiority comparison of the same vaccine phase 3 clinical trial was launched.

According to the drug clinical trial registration and information publicity platform, the main research purposes of this phase 3 clinical trial are as follows: (1) To investigate healthy people aged 2 months (minimum 6 weeks old), according to the 0, 2, and 4 months Inoculation of 1 dose, and the program of boosting 1 dose at 12-15 months of age, after inoculation with 13-valent pneumococcal polysaccharide conjugate vaccine, the level of serotype-specific pneumococcal IgG antibody of the vaccine is non-inferior to that of the same type vaccinated by the same immunization program Control vaccine; ② To investigate healthy people aged 3-6 months, inoculate 1 dose each at 0, 1, and 2 months, and boost 1 dose at 12-15 months of age, after inoculation with 13-valent pneumococcal polysaccharide conjugate vaccine , its vaccine serotype-specific pneumococcal IgG antibody level is non-inferior to 2-month-olds who are vaccinated at 0, 2, and 4 months with 1 dose each, and boosted with 1 dose at 12-15 months of age (minimum 6 weeks of age).

The secondary research objectives of this study include: (1) To evaluate the opsonophagocytic activity of vaccine serotype-specific pneumococcal antibodies after inoculation with 13-valent pneumococcal polysaccharide conjugate vaccine according to different immunization schedules in healthy people aged 2-71 months (minimum 6 weeks of age) ( OPA; Immune persistence of pneumococcal polysaccharide conjugate vaccines

Pneumococcal disease, an illness caused by infection with Streptococcus pneumoniae, affects children differently than adults, who are particularly susceptible to pneumococcal infection

References:

[1] China Drug Clinical Trial Registration and Information Publicity Platform.