Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01255124
Other study ID # JSVCT002
Secondary ID
Status Completed
Phase N/A
First received December 4, 2010
Last updated September 12, 2011
Start date October 2010
Est. completion date September 2011

Study information

Verified date September 2011
Source Jiangsu Province Centers for Disease Control and Prevention
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Observational

Clinical Trial Summary

Hand, Foot and Mouth Disease(HFMD)is an infectious disease in infants and young children caused by enterovirus. There was a great outbreak of HFMD in China, 2008, which brought not only panic to the people, but also huge economic loss. Since 2008, HFMD has become one of the category c infectious diseases in China. Studies showed that Human Enterovirus 71 (EV71) and coxsackievirus A 16 (CVA16) are the most common reasons for this disease. And the investigators are going to develop the vaccines for this disease. There is an urgent need to know the dynamic changes of the maternal anti-EV71 and ant-CVA16 level in infants and young children. In April 2007, the investigators started a clinical trial named 'The Safety and Immunogenicity of Recombinant Hepatitis B Vaccines in the Health Neonates' (ClinicalTrials.gov ID: NCT01183611). In that study the investigators already built a cohort of Health Neonates, followed them and obtained the blood serum on the day 0, 30, 210 and 360 after born. So, based on the cohort and blood serum the investigators got, the investigators plan this study to retrospectively investigate their HFMD histories from birth and follow-up for another year to get the information about the incidence of HFMD. The investigators also plan to assay the maternal anti-EV71 and anti-CVA16 antibodies on the day0 and the dynamic changes of antibodies on 1st month, 7th month (day 210), 1st year (day 360) and on October, 2010.


Description:

Hand, Foot and Mouth Disease(HFMD)is a common infectious disease in infants and young children which is caused by enterovirus. HFMD is one of the category c infectious diseases in China. However a group of picornavirus of enterovirus can caused HFMD, including coxsackievirus A (CVA), coxsackievirus B(CVB), Human Enterovirus 71(EV71), Echovirus(ECHO) and so on, EV71 and CVA16 are the most common reason for this disease. This study is carried out to discover dynamic changes of the maternal anti-EV71 and anti-CVA16 antibody in infants and young children from this study.

Infections of Hand, Foot and Month Disease in infants and young children may lead to a certain proportion of serious cases with various complications or death. The primary aim of this study is to find dynamic changes of the maternal anti-EV71 antibody in infants and young children and to provide basic data for the future application of EV71 vaccines. The second aim of this study is to find dynamic changes of the maternal anti- CVA16 antibody levels in infants and young children The third aim of this study is to discover the risk factors of Hand, Foot and Month Disease and to estimate the burden of disease.Hand, Foot and Mouth Disease(HFMD)is a common infectious disease in infants and young children caused by enterovirus. Since 2008, HFMD has become one of the category c infectious diseases in China. However a group of picornavirus of enterovirus can caused HFMD, including coxsackievirus A (CVA), coxsackievirus B(CVB), Human Enterovirus 71(EV71), Echovirus(ECHO) and so on, EV71 and CVA16 are the most common reason for this disease. This study is carried out to discover dynamic changes of the maternal anti-EV71 and ant-CVA16 in infants and young children from this study.

Infections of Hand, Foot and Month Disease in infants and young children may lead to a certain proportion of serious cases with various complications or death. The primary aim of this study is to find dynamic changes of the maternal anti-EV71 in infants and young children and to provide basic data for the future application of EV71 vaccines. The second aim of this study is to find dynamic changes of the maternal anti-CVA16 levels in infants and young children. The third aim of this study is to discover the risk factors of Hand, Foot and Month Disease and to estimate the burden of disease.


Recruitment information / eligibility

Status Completed
Enrollment 1297
Est. completion date September 2011
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender Both
Age group 2 Years to 3 Years
Eligibility Inclusion Criteria:

- The subjects participated in the clinical trial named 'The Safety and Immunogenicity of Recombinant Hepatitis B Vaccines in the Health Neonates'in 2007 (ClinicalTrials.gov ID: NCT01183611).

- Written informed consent obtained from the parent(s) of the subject.

- Subjects who the investigator believes will comply with the requirements of the protocol.

Exclusion Criteria:

- Neonatal jaundice requiring systemic treatment.

- Major congenital defects or serious chronic illness.

- Maldevelopment

- Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
China Jiangsu Provincial Center for Diseases Control and Prevention Nanjing Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
Jiangsu Province Centers for Disease Control and Prevention

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary dynamic changes of the maternal anti-EV71 dynamic changes of the maternal anti-EV71 in infants and young children from birth to 3 years old No
Secondary dynamic changes of the maternal anti-CVA16 dynamic changes of the maternal anti-CVA16 in infants and young children from birth to 3 years old No
Secondary incidence of HFMD retrospectively investigate their HFMD histories from birth and follow-up for another year to get the information about the incidence of HFMD. from birth to 3 years old No
See also
  Status Clinical Trial Phase
Recruiting NCT06063057 - Inactivated Bivalent Enterovirus Vaccine (Vero Cell) Phase I/II Clinical Trial Phase 1/Phase 2
Completed NCT04133584 - The Immunogenicity and Safety of the Vaccination of Inactivated Enterovirus 71 Vaccine and Seasonal Influenza Vaccine Phase 4
Completed NCT03241030 - Sucralfate to Improve Oral Intake in Children With Infectious Oral Ulcers: a Randomized, Double-blind, Placebo-Controlled Trial Phase 2
Completed NCT03873740 - Immunogenicity and Safety of Two Different Commercial EV71 Vaccines Phase 4
Completed NCT05637229 - A Serosurvey Study of Hand, Foot, and Mouth Disease in Indonesia
Recruiting NCT06146088 - Lot-to-lot Consistency Study of Three Commercial Batches of Enterovirus 71 Vaccine Phase 4
Active, not recruiting NCT06209398 - Immunogenicity of the Inactivated EV71 Vaccine Combined With Hepatitis B and Group A Meningococcal Vaccine Phase 4
Recruiting NCT01145664 - A Multi-Center Clinical Trial To Evaluate Chinese Herbal Medicines in the Treatment of Severe Hand-foot-mouth Disease N/A
Recruiting NCT01175915 - A Clinical Trial To Evaluate Reduning Injection in the Treatment of Mild Type of Hand, Foot, and Mouth Disease N/A
Completed NCT01182532 - A Clinical Trial to Evaluate the Effectiveness and Safety of Chinese Medicine in the Treatment of Mild Type of Hand, Foot, and Mouth Disease N/A
Completed NCT03281174 - Five-year Immune Persistence Study of Inactivated Enterovirus Type 71 (EV71) Vaccine N/A
Completed NCT03582761 - Efficacy Evaluation for Inactivated Vaccine (Vero Cell) Against EV71 Phase 4
Completed NCT03903926 - Efficacy Trial of a Commercial EV71 Vaccine Phase 4
Completed NCT02001233 - A Follow-up Study for a Phase III, Efficacy Trial in Inactivated Enterovirus Type 71 (EV71) Vaccine
Completed NCT03909074 - Clinical Trial of Enterovirus 71(EV71) Inactivated Vaccine in Children Aged 36-71 Months Phase 3
Completed NCT01769794 - Chinese Medicinal Treatment on Mild Hand, Foot, and Mouth Disease: Multicenter, Prospective, Randomized Double-blind, Placebo-controlled Study N/A
Recruiting NCT01182025 - A Clinical Trial to Evaluate the Effectiveness and Safety of Xiyanping Injection in the Treatment of Mild Type of Hand, Foot, and Mouth Disease N/A
Recruiting NCT06263439 - Surveillance of HFMD in Pediatric Outpatients
Not yet recruiting NCT05397587 - An Immunity Persistence Study of Enterovirus 71 Inactivated Vaccine (Vero Cell) Phase 4
Completed NCT04111432 - Safety and Immunogenicity of Concomitant Administration of EV71 Vaccine With Expanded Programme on Immunization Vaccines Phase 4