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Completed

NCT Number: NCT02200237

A Clinical Study for Inactivated Vaccine Against EV71

This study aims to evaluate the safety, reactogenicity and immunogenicity of EV71 vaccine in health children and infants aged from 2 months to <12yrs.

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Key information

Conditions

Enterovirus 71 Human

Age range

2 month–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chang-Guang Memorial Hospital Lin-Kou, Taipei, Taiwan

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Main Inclusion Criteria:

  • Healthy children and infants aged from 2 months to less than 12 years as established by medical history and clinical examination
  • The subjects' guardians are able to understand and sign the informed consent

Main Exclusion Criteria:

  • Subject with previous known exposure to EV71.
  • Subject with a history of herpangina or hand, foot and mouth disease associated with enterovirus infection in the past 3 months.
  • Subject who was diagnosed with a significant neurological, pulmonary, cardiovascular, hematological, hepatic or renal disorder.
  • Use of any investigational/non-registered product (including drug, vaccine and invasive medical device) within 30 days prior to vaccination or planned use during study period.
  • Subject with any confirmed or suspected autoimmune disorder, or immunodeficiency
  • Use of immunoglobulins or any blood products within 3 months prior to vaccination or planned use during the whole study period.

Treatment and study plan

EV71 with adjuvant aluminium phosphate

Biological

Two arms, EV71 with aluminium phosphate

Placebo

Biological

Phosphate Buffer Saline with adjuvant aluminium phosphate

Primary outcomes

  1. To evaluate overall safety of EV71 vaccine in children, throughout the study period

    Time frame: 2 years after study initiation

    Occurrence of overall adverse events and serious adverse events during the entire period of study.

Secondary outcomes

  1. To evaluate immunogenicity, serum neutralizing antibody titers humoral immune response, induced by candidate vaccine

    Time frame: 2 years from study initiation

    To evaluate the immunogencity in terms of

    • Geometric mean titer (GMT) of EV71 neutralizing antibody titers
    • Post-vaccination-to-pre-vaccination GMT ratio of EV 71 neutralizing antibody titers
    • Seropositivity rate

Sponsors and collaborators

Lead sponsor

Medigen Vaccine Biologics Corp.

Industry

Registry information

Acronym: EV71

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jul 25, 2014
Registry last updated
Aug 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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