Phase I/II Clinical Trial of 26-valent Pneumococcal Conjugate Vaccine

PHASE1/PHASE2Enrolling by invitationINTERVENTIONAL
Enrollment

450

Participants

Timeline

Start Date

August 27, 2024

Primary Completion Date

December 30, 2025

Study Completion Date

June 30, 2026

Conditions
Pneumococcal Vaccines
Interventions
BIOLOGICAL

26-Valent pneumococcal conjugate vaccine

As an experimental group. The active ingredient of 26-valent pneumococcal conjugate vaccine is the capsular polysaccharide of 26 pneumococcal serotypes conjugated to the tetanus toxoid carrier protein. Administer one dose of 0.5mL each time.

BIOLOGICAL

23-Valent pneumococcal polysaccharide vaccine

As a control group. The effective ingredients of 23-valent pneumococcal polysaccharide vaccine are 23 serotypes of pneumococcal capsular polysaccharides. Administer one dose of 0.5mL each time.

BIOLOGICAL

13-Valent pneumococcal conjugate vaccine

As a control group. The active ingredient of 13-valent pneumococcal conjugate vaccine is the capsular polysaccharide of 13 pneumococcal serotypes conjugated to the tetanus toxoid carrier protein. Administer one dose of 0.5mL each time.

Trial Locations (1)

476700

Henan Provincial Center for Disease Control and Prevention, Shangqiu

All Listed Sponsors
lead

Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

INDUSTRY