The purpose of this study is to assess the immunogenicity and safety of EV71 vaccine (Envacgen®) in Children Aged 6 to \<10 Years compared to Children Aged 2 to \<6 Years.
This is a prospective, open-label, multi-center, phase 3 study. Participants will receive the first IM injection of study vaccine on Day 1 and will receive a second dose 56 days later. The last study visit is on Day 237 when participants will be contacted via telephone to assess for adverse events .
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
378
Subjects are to receive a 0.5 mL IM injection of Envacgen®. Study drug is administered on Day 1 and Day 57 of the study.
National Taiwan University Hospital Hsin-Chu Branch
Hsinchu, Taiwan
RECRUITINGNational Taiwan University Hospital
Taipei, Taiwan
RECRUITINGChang Gung Medical Hospital Linkou
Taoyuan District, Taiwan
RECRUITINGImmunogenicity of Envacgen®
1. Geometric Mean Titer (GMT) of Neutralizing Antibody (NTAb) Measurement of NTAb titers against EV71 at 28 days after the second dose of Envacgen® in children aged 6 to \<10 years (Old group) compared with children aged 2 to \<6 years (Young group). 2. Seroresponse Rate (SRR) of Neutralizing Antibody (NTAb) Percentage of participants with seroresponse (defined as at least a four-fold increase from baseline in NTAb titers) at 28 days after the second dose of Envacgen® in children aged 6 to \<10 years (Old group) compared with children aged 2 to \<6 years (Young group).
Time frame: Day 1 to 28 days after the second vaccination.
Incidence of Adverse Events(AEs) [Safety]
Number and percentage of participants in the Old group (6 to \<10 years) and Young group (2 to \<6 years) with any reported adverse events within 28 days after vaccination with Envacgen®.
Time frame: Day 1 to 28 days after the second vaccination.
Incidence of Adverse Events(AEs) [Safety]
Number of participants with any adverse events (AEs) reported during the study period.
Time frame: Day 1 to 180 days after the second vaccination.
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