Immunogenicity and Safety Study of 15-Valent Pneumococcal Conjugate Vaccine in 2-month-old and 3-month-old Healthy Volunteers
NCT04357522 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1950
Last updated 2020-04-22
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
- 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.
Sponsors & Collaborators
-
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
lead INDUSTRY
Principal Investigators
-
Du Lin, Master · Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 6 Weeks
- Max Age
- 3 Months
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-07-31
- Primary Completion
- 2026-03-31
- Completion
- 2026-03-31
Countries
- China
Study Locations
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