The objectives of this study are to evaluate the EV71vaccine efficacy, immune response and safety profiles after two injections of the cell culture-based inactivated EV71 vaccine with adjuvant Al(OH)3 administrated in pediatric population aged 2 months to 6 years old.
The clinical trial designed in this Study is a placebo-controlled, double-blinded Phase III and is aimed to evaluate the vaccine efficacy, safety, immunogenicity and immune persistence of cell culture-based inactivated EV71 vaccine in children age of 2 months to \<6 years old. Two doses of Alum-adjuvanted 1.0 μg per dose of EV71 vaccine candidate will be administrated to subjects. The efficacy will be evaluated within a two year period after receiving 2-regimen vaccination by comparing the EV71-associated disease rates between the vaccine and placebo groups. Whereas, the immunogenicity will be assessed on Day 56 and Day 196, and the immune persistence will be evaluated on Day 392. Safety will be followed up to Day 392.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
3,982
EV71 vaccine (\[1 μg total protein + adjuvant 150 μg AI(OH)3\] per dose) Two vaccinations at 28 days apart
Placebo (\[ adjuvant 150 μg AI(OH)3\] per dose) Two vaccinations at 28 days apart
Changhua Christian Hospital
Changhua, Taiwan
National Taiwan University Hospital HsinChu Branch
Hsinchu, Taiwan
China Medical University Hospital
Taichung, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
The incidence rate of Hand, Foot and Mouth disease caused by EV71 after the second vaccination.
Evaluate the efficacy of EV71 vacccine against HFMD caused by EV71
Time frame: From 28 days after the second vaccination to two year
Serum neutralizing antibody titers (NT) induced by the EV71 vaccine
Evaluate the immunogenicity by the response rate
Time frame: 28 days after the second vaccination
The incidence rate of the severe complications and hospitalization of EV71 associated HFMD/HA disease after the second vaccination.
1. Evaluate the efficacy of vaccination against the severe complications, including neurologic, pulmonary edema, and cardiorespiratory failure, of EV71 associated HFMD/HA diseases after completion of full vaccination. 2. Evaluate the efficacy of vaccination against the hospitalization of EV71 associated HFMD/HA diseases after completion of full vaccination.
Time frame: From 28 days after the second vaccination to two year
Serum neutralizing antibody titers (NT) induced by the EV71 vaccine
1. Evaluate the immunogenicity of EV71 vaccine with two-dose regimen. 2. Evaluate the immune persistence of EV71 vaccine with two-dose regimen. 3. Evaluate lot-to-lot consistency by comparing the immunogenicity induced by 3 independent EV71 vaccines.
Time frame: Day 0,56,196,and 392
Adverse events of EV71 vaccine
1. Occurrence and severity of solicited injection site relations and general reactions within 7 days following each injection. 2. Occurrence and severity of unsolicited adverse events within 28 days following each injection. 3. Occurrence and relations with vaccination of some special AE during the 6-months follow-up period (up to Day 196). 4. Occurrence and relations with vaccination of serious adverse events (SAEs) during the one year follow-up period (up to Day 392).
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National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan District, Taiwan
Pasteur Institute of HCMC
Ho Chi Minh City, Vietnam
Time frame: Day 0 to Day 392