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Hand, Foot and Mouth Disease clinical trials

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NCT ID: NCT06455007 Completed - Clinical trials for Propolis Antiviral Activity

Propolis as a Treatment Option for Hand Foot and Mouth Disease

Start date: January 1, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

Hand foot and mouth disease (HFMD) is a frequently self-limited viral infectious disease in children with no specific antiviral treatment option. There has been an increasing interest in bee products in recent years, and propolis has come to the fore with its high therapeutic and protective effect. Although the inhibitory effect of propolis against enteroviruses (EVs) has been shown in studies, there is no clinical data regarding its use in the course of HFMD. The aim of this prospective multicenter randomized clinical study was to evaluate the effect of propolis use in children with HFMD. The patients were randomly assigned to have Anatolian propolis or no supplement - control group in addition to symptomatic therapy decided by the physician. The duration of the patients' complaints, the distribution of the lesions in the body, and the fever status were recorded on admission. Parents were asked to rate the severity of the child's restlessness, inappetence, and sleeplessness status on a scale of 0-10 on the initial, 2nd (at 48th hour), and 3rd (on 5-7 days) visits.

NCT ID: NCT06353477 Completed - Clinical trials for Hand, Foot, and Mouth Disease

Hand, Foot, and Mouth Disease: Could EPs®7630 be a Treatment Option

Start date: June 1, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

This randomized controlled study aims to evaluate the effectiveness and safety of the pharmaceutical extract EPs® 7630 from P.sidoides in treating hand, foot, and mouth disease in children. The study will investigate the impact of EPs® 7630 on the severity of the disease over a specific period and its effects on hospitalization rates and potential complications. This research aims to contribute to the treatment of hand, foot, and mouth disease in children.

NCT ID: NCT05637229 Completed - Clinical trials for Hand, Foot and Mouth Disease

A Serosurvey Study of Hand, Foot, and Mouth Disease in Indonesia

Start date: November 28, 2022
Phase:
Study type: Observational [Patient Registry]

This study is a sero-survey study of infants aged 6 months to 71 months in Bandung City and West Bandung District. As initial data to find out how many children have been exposed to human enterovirus type 71 (HEV-71) which causes Hand, foot, and mouth disease (HFMD).

NCT ID: NCT04467541 Completed - Clinical trials for Hand Foot & Mouth Disease

Safety & Immunogenicity of Enterovirus Type 71 Vaccine in Healthy Adults and Children 6-71months

Start date: December 24, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

1. Burden: Hand-foot-and-mouth disease (HFMD) characterized by skin rash in extremities, mouth ulcer and fever among <5 years children.Primarily caused by Enterovirus- predominantly human Enterovirus (EV) 71 and Coxsackie virus (CoxA). Several large epidemics have been reported worldwide.Large Asia-Pacific epidemic-in China in 2008, approximately 490,000 infections and 126 deaths of children. EV71 contributes severe and fatal cases e.g. encephalitis.A recent outbreak of HFMD in Bhubaneswar, Odisha in India indicates there is a chance of HFMD outbreaks in Bangladesh. However there is not much report of HFMD from Bangladesh. 2. Knowledge gap: EV71 is most commonly transmitted via close person-to-person contact. Since there is no known effective treatment for HFMD and as the causative virus is highly contagious, hand washing is the best defense for prevention. However, asymptomatic or mild nature of the infection leads to ineffectiveness of public health interventions like hand washing. Thus the symptomatic management remains the mainstay of treatment strategy for HFMD as of now. EV71 vaccine, an inactivated vaccine, developed by Sinovac Biotech Ltd has shown satisfactory safety and effectiveness through Phase III trials conducted in various regions of mainland China, This new vaccine has the potential to significantly reduce suffering and death from EV71 disease in China. However, it is not assessed on Bangladeshi child. 3. Relevance: Due to the absence of effective public health strategy and proper treatment, the development of an effective vaccine may be the best way to control EV71 infection.

NCT ID: NCT04133584 Completed - Seasonal Influenza Clinical Trials

The Immunogenicity and Safety of the Vaccination of Inactivated Enterovirus 71 Vaccine and Seasonal Influenza Vaccine

Start date: September 16, 2019
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the Immunogenicity and safety of the simultaneously vaccination of Inactivated Enterovirus 71 Vaccine (EV71) and seasonal influenza vaccine(SIV)

NCT ID: NCT04111432 Completed - Clinical trials for Hand, Foot and Mouth Disease

Safety and Immunogenicity of Concomitant Administration of EV71 Vaccine With Expanded Programme on Immunization Vaccines

Start date: July 26, 2019
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the safety and immunogenicity of concomitant administration of EV71 vaccine with measles mumps, and rubella combined live attenuated vaccine/ encephalitis live attenuated vaccine.

NCT ID: NCT03909074 Completed - Clinical trials for Hand, Foot and Mouth Disease

Clinical Trial of Enterovirus 71(EV71) Inactivated Vaccine in Children Aged 36-71 Months

Start date: March 10, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the non-inferiority of experimental EV71 vaccine compared to the control EV71 vaccine in children aged 36-71 months, to evaluate the non-inferiority of EV71 vaccine used in children aged 36-71 months compared to 6-35 months. The experimental vaccine was manufactured by Sinovac Biotech Co., Ltd, and the control vaccine was manufactured by Institute of Medical Biology Chinese Academy of Medical Sciences.

NCT ID: NCT03903926 Completed - Clinical trials for Hand, Foot and Mouth Disease

Efficacy Trial of a Commercial EV71 Vaccine

Start date: March 26, 2019
Phase: Phase 4
Study type: Interventional

The purpose of this post-marketing study is to evaluate the efficacy, immunogenicity, and safety of the EV71 vaccine post marketing, and explore the protective levels of various enterovirus neutralizing antibodies

NCT ID: NCT03893747 Completed - Clinical trials for Hand, Foot and Mouth Disease

Immunity and Safety of Inactivated Enterovirus 71 Vaccine Post-marketing Among Children Aged 6-35 Months in China

Start date: April 1, 2019
Phase: Phase 4
Study type: Interventional

This study evaluates three batches consistency, immunity duration and safety of inactivated Enterovirus 71(EV-A71) vaccine(vero cell) post-marketing among children aged 6-35months in China.3000 subjects will be recruited in this study, of who 1500 subjects will be randomly assigned in a ratio of 1:1:1 to receive one of the three batches of EV-A71 vaccines manufactured by 40L capacity reactor, other 1500 subjects will be randomly assigned in a ratio of 1:1:1 to receive one of the three batches of EV-A71 vaccines manufactured by 150L capacity reactor. Vaccine wil be administrated according to a two doses of schedule given at day 0 and 28. Sample will be collected at day 0, day 56 and at month 13 after vaccinaiton.

NCT ID: NCT03873740 Completed - Clinical trials for Hand, Foot and Mouth Disease

Immunogenicity and Safety of Two Different Commercial EV71 Vaccines

Start date: November 6, 2018
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the immunogenicity and safety of sequential vaccination of two EV71 inactived vaccines in healthy infants aged 6-35 months.