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A Study to Evaluate the Safety and Immunogenicity of EV71 Vaccine in Pediatric Subjects Aged 3 to 6 Years and 6 to 35 Months Old | Clinical Trials | Clareo Health

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A Study to Evaluate the Safety and Immunogenicity of EV71 Vaccine in Pediatric Subjects Aged 3 to 6 Years and 6 to 35 Months Old

An Open-label, Dose-finding, Phase II Study to Evaluate the Safety and Immunogenicity of EV71 Vaccine in Pediatric Subjects Aged 3 to 6 Years and 6 to 35 Months Old

NCT02777411•Enimmune Corporation

View on ClinicalTrials.gov

Summary

The objectives of this study are to evaluate the immune response and safety profiles of two injections of EV71 vaccine administrated with or without adjuvant AlPO4 at 0.5-μg, 1-μg, 2-μg and 5-μg dose (if required) in children aged 3 to 6 years old and 0.25-μg (if required), 0.5-μg, 1-μg and 2-μg (if required) in 6 to 35 months old infants/toddlers.

Eligibility

Age

0 - 6 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Healthy children aged from 3 to 6 years old (i.e. ≥ 3 years old and \< 7 years old) for Part A; from 6 to 35 months old (i.e. ≥ 6 months old and \< 36 months old) for Part B at the time of first vaccination.
•2. Subject's guardians were able and willing to comply with study procedures and give written informed consent.
•3. Subject was able and could comply with the requirements of the protocol.
•4. Subject with body temperature ≤38°C.

Exclusion Criteria

•1. Subject with previous known exposure to Enterovirus 71 (EV71).
•2. Subject with a history of herpangina, hand-foot-mouth disease, acute hemorrhagic conjunctivitis associated with enterovirus infection in the past 3 months.
•3. Subject with gestation \< 37 weeks.
•4. Subject with birth weight \<2.5 kg.
•5. Subject with a history of hypersensitivity to vaccines, or a history of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
•6. Family history of seizures or progressive neurological disease.
•7. Family history of congenital or hereditary immunodeficiency.
•8. Severe malnutrition or dysgenopathy.
•9. Major congenital defects or serious chronic illness, including perinatal brain damage.
•10. Subject diagnosed of having autoimmune disease (e.g., celiac disease, type I diabetes, lupus (SLE), juvenile dermatomyositis, scleroderma, juvenile idiopathic arthritis (JIA), immune (or idiopathic) thrombocytopenia purpura).
+8 more criteria

Locations (4)

China Medical University Hospital

Taichung, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Linkou Chang Gung Memorial Hospital

Taoyuan District, Taiwan

Key Dates

Start Date

December 1, 2014

Primary Completion Date

January 1, 2016

Completion Date

January 1, 2016

Last Updated

November 30, 2016

Enrollment

122

ACTUAL participants

Conditions

Enterovirus Infections

Interventions

EV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AIPO4] per dose)

BIOLOGICAL

EV71 vaccine ([1 μg total protein + adjuvant 150 μg AIPO4] per dose)

BIOLOGICAL

EV71 vaccine ([2 μg total protein + adjuvant 150 μg AIPO4] per dose)

BIOLOGICAL

EV71 vaccine (2 μg total protein per dose)

BIOLOGICAL

EV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AIPO4] per dose)

BIOLOGICAL

EV71 vaccine ([1 μg total protein + adjuvant 150 μg AIPO4] per dose)

BIOLOGICAL

EV71 vaccine (1 μg total protein per dose)

BIOLOGICAL

Molecular Epidemiology of Enteroviruses Detected at the Virology Laboratory of Brest University Hospital During the Period 2018-2024: Retrospective Analysis of an Atypical Meningitis Epidemic in 2024 (BrEcho9Men)

NCT06922474

Enterovirus InfectionsMeningitis, Viral+2 more

View study

TERMINATED

Evaluation of a Single Use Point of Care Device for the Diagnosis of Respiratory Pathogens

NCT04431050

Human InfluenzaRespiratory Syncytial Virus Infections+4 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 30, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Evaluate the Safety and Immunogenicity of EV71 Vaccine in Pediatric Subjects Aged 3 to 6 Years and 6 to 35 Months Old

Inclusion Criteria

Exclusion Criteria

Molecular Epidemiology of Enteroviruses Detected at the Virology Laboratory of Brest University Hospital During the Period 2018-2024: Retrospective Analysis of an Atypical Meningitis Epidemic in 2024 (BrEcho9Men)

Evaluation of a Single Use Point of Care Device for the Diagnosis of Respiratory Pathogens

Urinary Excretion of Enteroviruses From Children With a Presumed Enteroviral Infection