Clinical Trial: Safety, Three Batches Consistency and Immunity Duration of the Post-marketing Inactivated Enterovirus Type 71 (EV71) Vaccine in Children Aged 6-71 Months
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title:
Brief Summary: This study evaluates the safety,three batches consistency and immunity duration of the post-marketing inactivated Enterovirus Type 71 (EV71) vaccine in children aged 6-71 months.This study has two groups:safety observation group and immunogenicity observation group.20000 subjects will receive 2 doses vaccines and be observed for safety among 2 epidemic cycles of HFMD.In the immunogenicity observation group, 900 subjects will be randomly received 3 batches vaccines(2 doses),and blood sampled at days 0 and 56.
Detailed Summary:
Sponsor: Beijing Chaoyang District Centre for Disease Control and Prevention
Current Primary Outcome:
- Evaluate the Rate of Adverse reactions of Post-marketing Inactivated Enterovirus Type 71 (EV71) Vaccine in Children Aged 6-71 Months. [ Time Frame: 24 months ]Adverse reactions associated with vaccine will be observed in Children Aged 6-71 Months 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.
- Evaluate the seroconversion rate of EV71 antibodies in serum after vaccination. [ Time Frame: 56 days ]The seroconversion rate of EV71 antibodies will be evaluated in serum at days 0 and 56.
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Beijing Chaoyang District Centre for Disease Control and Prevention
Dates:
Date Received: August 31, 2016
Date Started: September 2016
Date Completion: September 2019
Last Updated: September 6, 2016
Last Verified: August 2016
