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RECRUITING
NCT07333352
PHASE2

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

Sponsor: Shanghai Reinovax Biologics Co.,LTD

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

6 Weeks - 71 Months

Study Type

INTERVENTIONAL

Enrollment

480

Start Date

2025-09-11

Completion Date

2027-08

Last Updated

2026-01-16

Healthy Volunteers

Yes

Interventions

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.

Locations (7)

Luzhou District Center for Disease Control and Prevention

Changzhi, Shanxi, China

Qinxian County Center for Disease Control and Prevention

Changzhi, Shanxi, China

Kuangqu District Center for Disease Control and Prevention of Yangquan City

Yangquan, Shanxi, China

Xinjiang County Center for Disease Control and Prevention

Yuncheng, Shanxi, China

Jishan County Center for Disease Control and Prevention

Yuncheng, Shanxi, China

Yongji City Center for Disease Control and Prevention

Yuncheng, Shanxi, China

Shangdang District Center for Disease Control and Prevention of Changzhi City

Yuncheng, Shanxi, China