A Study to Evaluate the Efficacy, Safety, and Immunogenicity of an EV71 Vaccine

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

3061 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-23

Study Completion Date

2021-04-16

Brief Summary

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Subjects will receive the first IM injection of study vaccine on Day 1 and will receive a second dose 56 days later. A booster vaccine will be given 365 days after the first dose in subjects 2 months to \< 2 years of age. The last study visit is on Day 422 when subjects will be contacted via telephone / home visit system to assess for adverse events and concomitant medications.

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Detailed Description

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Conditions

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Enterovirus 71 Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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EV71vac

Group Type EXPERIMENTAL

EV71vac

Intervention Type BIOLOGICAL

Subjects are to receive a 0.5 mL IM injection of EV71vac. Study drug is administered on Day 1 and Day 57 of the study. Subjects 2 months to \< 2 years of age will receive a booster vaccination on Day 366.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Subjects are to receive a 0.5 mL IM injection of placebo. Study drug is administered on Day 1 and Day 57 of the study. Subjects 2 months to \< 2 years of age will receive a booster vaccination on Day 366.

Interventions

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EV71vac

Subjects are to receive a 0.5 mL IM injection of EV71vac. Study drug is administered on Day 1 and Day 57 of the study. Subjects 2 months to \< 2 years of age will receive a booster vaccination on Day 366.

Intervention Type BIOLOGICAL

Placebo

Subjects are to receive a 0.5 mL IM injection of placebo. Study drug is administered on Day 1 and Day 57 of the study. Subjects 2 months to \< 2 years of age will receive a booster vaccination on Day 366.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. Healthy children and infants aged from 2 months to less than 6 years as established by medical history and clinical examination.
2. The subjects' parents/guardians are able to understand and sign the ICF.

Exclusion Criteria

1. Age \< 2 months or ≥ 6 years.
2. For subjects \< 1 year, gestational age \< 34 weeks or birth weight \< 2200 grams.
3. Has poor venous access (for subjects in sub-study only).
4. Currently has a fever defined as ear/rectal temperature ≥ 38°C or axillary temperature ≥ 37.5 °C within 2 days before the time of planned vaccination.
5. Has had previous known exposure to EV71 or has received EV71 vaccine.
6. Has a history of herpangina or HFMD associated with enterovirus infection in the past 30 days before the date of the planned study drug vaccination.
7. Has been diagnosed with a significant neurological, pulmonary, cardiovascular, hematological, hepatic, or renal disorder.
8. Has a history of hypersensitivity to vaccines, or a history of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
9. Has used any investigational/non-registered product (including drug, vaccine, or invasive medical device) within 28 days before vaccination or plan to use during the study period.
10. Has confirmed or suspected autoimmune disorder, or immunodeficiency.
11. Administration of any licensed live attenuated vaccine within 14 days before or after each study vaccination (with the exceptions of live attenuated Rotavirus vaccine via oral route).
12. Has used immunoglobulins or any blood products within 11 months before vaccination or plan to use during the whole study period.
13. Has had immunosuppressants, cytotoxic drugs, corticosteroids (including prednisolone ≥ 0.5 mg/kg/day or equivalent), or immunomodulators taken for \> 14 days within 6 months before first vaccination or plan to use before the last scheduled study visit. (Inhaled and topical steroids are allowed).
14. Has any medical or psychiatric condition, that is a contraindication to protocol participation based on the judgment of the Investigator.

Minimum Eligible Age

2 Months

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes