A Follow-up Study for a Phase III, Efficacy Trial in Inactivated Enterovirus Type 71 (EV71) Vaccine
|ClinicalTrials.gov Identifier: NCT02001233|
Recruitment Status : Completed
First Posted : December 4, 2013
Last Update Posted : May 22, 2015
|Condition or disease||Intervention/treatment|
|Hand, Foot and Mouth Disease||Biological: EV71 vaccine|
The phase III, efficacy trial of inactivated vaccine (vero cell) against EV71 has completed on March 2013 in China. The data from the phase III study suggested that the inactivated EV71 vaccine had protection effects on healthy Chinese infants against Hand, Foot and Mouth disease caused by EV71 within one-year surveillance period, and had clinically acceptable safety and good one-year immune persistence.
This study is the phase III, open-labelled, follow-up research, in order to evaluate the two-year efficacy, safety and immune persistence.
|Study Type :||Observational|
|Actual Enrollment :||10077 participants|
|Observational Model:||Case Control|
|Official Title:||An Open-labelled, Multicentered, Follow-up Study for a Phase III, Efficacy Trial to Evaluate the Two-year Efficacy, Safety, and Immune Persisitence of Inactivated Enterovirus Type 71 (EV71) Vaccine|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||October 2014|
Inactivated vaccine (vero cell) against EV71 of 400U /0.5ml in 5000 infants aged 6-35 months old on day0,28
Biological: EV71 vaccine
inactivated vaccine (vero cell) against EV71 of 400U /0.5ml, two doses, 28 days interval
placebo in 5000 infants aged 6-35 months old on day0,28
- The incidence rate of Hand, Foot and Mouth disease caused by EV71 within the second year observation period after the second vaccination [ Time Frame: Within the second year after the second vaccination ]to evaluate the efficacy of EV71 vacccine against HFMD caused by EV71
- The GMT of anti-EV71 antibodies in serum two years after second vaccination [ Time Frame: 26 months after second vaccination ]to evaluate the immune persistence of anti-EV71 antibodies in serum
- Frequency of serious adverse events (SAEs) with the second year after the second vaccination [ Time Frame: within the second year after the second vaccination ]Frequency of serious adverse events in healthy infants during the oney-year follow-up period
Biospecimen Retention: Samples With DNA
Serum samples will be taken from 1200 subjects in the immunogenicity subgroup 26 months after the first vaccination.
Throat and anal swab samples will be taken from the cases with Hand, Foot and mouth disease for the detection of PCR assays and the isolation of EV71.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02001233
|Lianyungang, Jiangsu, China, 222100|
|Taizhou, Jiangsu, China, 225400|
|Yancheng, Jiangsu, China, 224300|
|Principal Investigator:||Feng-Cai Zhu, BS||Jiangsu Center for Diseases Control and Prevention|