Trial intelligence / Profile preview

Phase II Dose-Finding Study of EV71 Vaccine in Children

NCT02777411Phase 2

Key facts

Status: Completed
Start: Dec 2014
Primary completion: Jan 2016
Countries: 1
Sponsor: Enimmune
Modality: Whole Inactivated Vaccines

Drugs: envax-a71
Conditions: enterovirus 71 infection

Overview

Phase 2, randomised, open-label trial of envax-a71 in enterovirus 71 infection (7 arms), sponsored by Enimmune. Primary endpoints: Solicited adverse events, Unsolicited adverse events and 1 more. Started Dec 2014; status: completed.

Design

7 arms

Study design: RandomizedOpen-label

Group A1
3-6 years, 0.5 µg + adjuvant
Group A2
3-6 years, 1 µg + adjuvant
Group A3
3-6 years, 2 µg + adjuvant
Group A4
3-6 years, 2 µg no adjuvant
Group B2
6-35 months, 0.5 µg + adjuvant
Group B3
6-35 months, 1 µg + adjuvant

1 more in the full profile.

Who it enrols

Healthy children aged 6 months to 6 years without prior exposure to EV71 or history of HFMD/herpangina.

Endpoints

Primary

Solicited adverse events7 days after each vaccination
Unsolicited adverse events28 days after each vaccination
Occurrence of overall adverse events and serious adverse eventsDay 0 to Day 196

Secondary

Immunoglobulin G titers induced by the EV71 vaccineDay 196
Serum neutralizing antibody titers induced by the EV71 vaccineDay 196
Seroconversion rate based on neutralizing antibody titersDay 196
Change in hematology test resultsDay 196
Change in biochemistry test resultsDay 196
Change in heart ratesDay 196
Change in blood pressuresDay 196

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