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

NCT02544698 Phase 1 UNKNOWN

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.

Details

Lead sponsor	Beijing Chaoyang District Centre for Disease Control and Prevention
Phase	Phase 1
Status	UNKNOWN
Enrolment	120
Start date	2015-11
Completion	2016-12

Conditions

• Pneumococcal 13-valent Conjugate Vaccine

Interventions

• One dose of PCV13a vaccine
• One dose of PCV13a vaccine
• three doses of PCV13a vaccine
• three doses of PCV13a vaccine

Primary outcomes

• Evaluate the rate of adverse reactions of pneumococcal 13-valent conjugate vaccine — 3 months
  Adverse reactions associated with vaccine will be observed in subjects after vaccination. Solicited local adverse events include Pain, Redness, Swelling, Induration, Rash, Pruritus at injection site. solicited general adverse events include Fever, Nausea, Vomiting, Diarrhea, Decreased appetite, Be agitated (irritability, abnormal crying), fatigue, allergy