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

NCT03865238 | Completed Phase 3

• 1 other identifier: CT-EV-31
• Study Type: interventional
• Target: 3,061
• Locations: 2 countries
• Sites: 6

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.

Conditions

Enterovirus 71 Infection

Outcome Measures

Primary Outcomes (1)

• Number of Laboratory Confirmed EV71-Associated Disease

  The primary outcome is the number of Laboratory confirmed EV71-associated disease by viral isolation or CODEHOP assay.

  Approximately 14 months

Study Arms (2)

EV71vac

EXPERIMENTAL

Biological: EV71vac

Placebo

PLACEBO COMPARATOR

Biological: Placebo

Interventions

EV71vac 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.

EV71vac

Placebo 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.

Placebo

Eligibility Criteria

• Age: 2 Months - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Age \< 2 months or ≥ 6 years.
• For subjects \< 1 year, gestational age \< 34 weeks or birth weight \< 2200 grams.
• Has poor venous access (for subjects in sub-study only).
• 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.
• Has had previous known exposure to EV71 or has received EV71 vaccine.
• 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.
• Has been diagnosed with a significant neurological, pulmonary, cardiovascular, hematological, hepatic, or renal disorder.
• 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.
• 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.
• Has confirmed or suspected autoimmune disorder, or immunodeficiency.
• 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).
• Has used immunoglobulins or any blood products within 11 months before vaccination or plan to use during the whole study period.
• 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).
• Has any medical or psychiatric condition, that is a contraindication to protocol participation based on the judgment of the Investigator.

Sponsors & Collaborators

• Medigen Vaccine Biologics Corp.: lead

Study Sites (6)

Mackay Memorial Hospital, HsincChu

Hsinchu, Taiwan

Location

Taichung Veteran General Hospital

Taichung, Taiwan

Location

Mackay Memorial Hospital, Taipei

Taipei, Taiwan

Location

National Taiwan Univeristy Hospital

Taipei, Taiwan

Location

Chang Gung Memorial Hospital, LinKou

Taoyuan District, Taiwan

Location

Pasteur Institute of HCMC

Ho Chi Minh City, Vietnam

Location

Related Publications (1)

• Nguyen TT, Chiu CH, Lin CY, Chiu NC, Chen PY, Le TTV, Le DN, Duong AH, Nguyen VL, Huynh TN, Truong HK, Phan TL, Nguyen TTT, Shih SR, Huang CG, Weng YJ, Hsieh EF, Chang S, Chen C, Tai IC, Huang LM. Efficacy, safety, and immunogenicity of an inactivated, adjuvanted enterovirus 71 vaccine in infants and children: a multiregion, double-blind, randomised, placebo-controlled, phase 3 trial. Lancet. 2022 Apr 30;399(10336):1708-1717. doi: 10.1016/S0140-6736(22)00313-0. Epub 2022 Apr 12.

  PMID: 35427481 DERIVED

Study Officials

• Li-Min Huang, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2019
• First Posted: March 6, 2019
• Study Start: April 23, 2019
• Primary Completion: April 16, 2021
• Study Completion: April 16, 2021
• Last Updated: April 19, 2022

Record last verified: 2021-06

Locations

VN (1); TW (5)