NCT07333352

PCV24 Clinical Trial in Infants and Young Children Aged 2 Months (Minimum 6 Weeks) to 71 Months

Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of A 24-Valent Pneumococcal Polysaccharide Conjugate Vaccine (RZ700) in Infants and Young Children Aged 2 Months (Minimum 6 Weeks) to 71 Months

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 480 (estimated)
• Sponsor: Shanghai Reinovax Biologics Co.,LTD · Industry
• Sex: All
• Age: 6 Weeks – 71 Months
• Healthy volunteers: Accepted

Summary

The Phase II clinical trial of the 24-valent pneumococcal polysaccharide conjugate vaccine (RZ700) will be carried out in infants and young children aged 2 months (minimum 6 weeks) to 71 months. The purpose of this study is to evaluate the immunogenicity and safety of the 24-valent pneumococcal polysaccharide conjugate vaccine.

Conditions

• Pneumococcal Infectious Disease

Interventions

Type	Name	Description
BIOLOGICAL	24-Valent Pneumococcal Polysaccharide Conjugate Vaccine (RZ700)	24-Valent Pneumococcal Polysaccharide Conjugate Vaccine (RZ700) consisting of polysaccahrides from 24 pneumococcal serotypes: 1, 2, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F conjugated two carrier proteins. Each dose contains 0.5 ml vaccine in a prefilled syringe.
BIOLOGICAL	13-Valent Pneumococcal Polysaccharide Conjugate Vaccine (Prevnar 13)	13-Valent Pneumococcal Polysaccharide Conjugate Vaccine (Prevnar 13) consisting of plosaccharides from 13 pneumococcal serotypes: 1, , 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F conjugated CRM197. Each dose contains 0.5 ml vaccine in a prefilled syringe.

Timeline

• Start date: 2025-09-11
• Primary completion: 2027-07-01
• Completion: 2027-08-01
• First posted: 2026-01-12
• Last updated: 2026-01-16

Locations

7 sites across 1 country: China