NCT02544698

Safety Study of Pneumococcal 13-valent Conjugate Vaccine in Healthy People Aged 2 Months and Older

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Beijing Chaoyang District Centre for Disease Control and Prevention · Academic / Other
• Sex: All
• Age: 2 Months
• Healthy volunteers: Accepted

Summary

This study evaluates the safety of Pneumococcal 13-valent Conjugate Vaccine in Healthy People Aged 2 Months and Older.120 Subjects will be equally divided into 4 groups,including 18 years and older,2-5 years old, 2 months old and 3 months old. Subjects aged 18 years and 2-5 years old will receive one dose of PCV13 vaccine,while subjects aged 2 and 3 months will receive 3 doses of PCV13 vaccine,injected at 2, 4, 6 months or 3、4、5 months respectively.

Conditions

• Pneumococcal 13-valent Conjugate Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	One dose of PCV13a vaccine
BIOLOGICAL	One dose of PCV13a vaccine
BIOLOGICAL	three doses of PCV13a vaccine
BIOLOGICAL	three doses of PCV13a vaccine

Timeline

• Start date: 2015-11-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2015-09-09
• Last updated: 2016-06-17