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

Phase 3

Completed

• Conditions: Enterovirus 71 Infection
• Interventions: Biological: Placebo; Biological: EV71vac

• Registration Number: NCT03865238
• Lead Sponsor: Medigen Vaccine Biologics Corp.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-20
• Study First Submitted QC: 2019-03-04
• Study First Posted: 2019-03-06
• Study Start: 2019-04-23
• Primary Completion: 2021-04-16
• Study Completion: 2021-04-16
• Status Verified: 2021-06
• Last Update Submitted: 2022-04-18
• Last Update Posted: 2022-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3061

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
EV71vac	EV71vac	-

Primary Outcome Measures

Name	Time	Method
Number of Laboratory Confirmed EV71-Associated Disease	Approximately 14 months	The primary outcome is the number of Laboratory confirmed EV71-associated disease by viral isolation or CODEHOP assay.

Trial Locations

Locations (6)

Taichung Veteran General Hospital; 🇨🇳 Taichung, Taiwan

National Taiwan Univeristy Hospital; 🇨🇳 Taipei, Taiwan

Pasteur Institute of HCMC; 🇻🇳 Ho Chi Minh City, Vietnam

Chang Gung Memorial Hospital, LinKou; 🇨🇳 Taoyuan, Taiwan

Mackay Memorial Hospital, HsincChu; 🇨🇳 Hsinchu, Taiwan

Mackay Memorial Hospital, Taipei; 🇨🇳 Taipei, Taiwan