A Clinical Study for Inactivated Vaccine Against EV71

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

366 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2017-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Long-Term Immunogenicity Study of Inactivated EV71 Vaccine in Children

NCT04072276

Enterovirus 71 Human

COMPLETED

Safety and Immunogenicity of an Inactivated EV71 Vaccine in Infants

NCT01421121

Infection, Viral, Enterovirus

COMPLETED PHASE2

A Follow-up Study for a Phase III, Efficacy Trial in Inactivated Enterovirus Type 71 (EV71) Vaccine

NCT02001233

Hand, Foot and Mouth Disease

COMPLETED

Study on the Persistence of Immunity Following EV71 Vaccination

NCT07144202

Hand, Foot, and Mouth Disease Hand, Foot, and Mouth Disease (HFMD)

ENROLLING_BY_INVITATION

The Phase IVc of Inactivated Enterovirus 71 Vaccine (Human Diploid Cell)

NCT03240744

Hand, Foot and Mouth Disease (HFMD)

UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Enterovirus 71 Human

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

Phosphate Buffer Saline with adjuvant aluminium phosphate

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Phosphate Buffer Saline with adjuvant aluminium phosphate

EV71 with adjuvant aluminium phosphate

Inactive whole monovalent EV71 virion vaccine formulated with phosphate-buffered saline based adjuvanted aluminium phosphate 150 μg/0.5ml

Group Type EXPERIMENTAL

EV71 with adjuvant aluminium phosphate

Intervention Type BIOLOGICAL

Two arms, EV71 with aluminium phosphate

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

EV71 with adjuvant aluminium phosphate

Two arms, EV71 with aluminium phosphate

Intervention Type BIOLOGICAL

Placebo

Phosphate Buffer Saline with adjuvant aluminium phosphate

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

1. Subject with previous known exposure to EV71.
2. Subject with a history of herpangina or hand, foot and mouth disease associated with enterovirus infection in the past 3 months.
3. Subject who was diagnosed with a significant neurological, pulmonary, cardiovascular, hematological, hepatic or renal disorder.
4. 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.
5. Subject with any confirmed or suspected autoimmune disorder, or immunodeficiency
6. Use of immunoglobulins or any blood products within 3 months prior to vaccination or planned use during the whole study period.

Minimum Eligible Age

2 Months

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes