NCT04357522

Immunogenicity and Safety Study of 15-Valent Pneumococcal Conjugate Vaccine in 2-month-old and 3-month-old Healthy Volunteers

A Single-center, Randomised, Blind, Similar Vaccine Control, Non-inferior Designed Phase III Clinical Trial to Evaluate Immunogenicity and Safety Study of 15-Valent Pneumococcal Conjugate Vaccine in 2-month-old and 3-month-old Healthy Volunteers

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,950 (estimated)
• Sponsor: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 6 Weeks – 3 Months
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate Immunogenicity and safety of 15-Valent Pneumococcal Conjugate Vaccine in healthy volunteers aged 2 and 3 months.

Conditions

• Pneumonia, Pneumococcal

Interventions

Type	Name	Description
BIOLOGICAL	15-Valent Pneumococcal Conjugate Vaccine	4/1 dose(s) according to age of subjects. Single intramuscular dose contains 0.5ml 15-Valent Pneumococcal Conjugate Vaccine.
BIOLOGICAL	13-Valent Pneumococcal Conjugate Vaccine	4/1 dose(s) according to age of subjects. Single intramuscular dose contains 0.5ml 15-Valent Pneumococcal Conjugate Vaccine.

Timeline

• Start date: 2020-07-01
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2020-04-22
• Last updated: 2020-04-22

Locations

3 sites across 1 country: China