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A Study to Evaluate the Safety and Immunogenicity of EV71 Vaccine in Pediatric Subjects Aged 3 to 6 Years and 6 to 35 Months Old

NCT02777411 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2016-11-30

No results posted yet for this study

Summary

The objectives of this study are to evaluate the immune response and safety profiles of two injections of EV71 vaccine administrated with or without adjuvant AlPO4 at 0.5-μg, 1-μg, 2-μg and 5-μg dose (if required) in children aged 3 to 6 years old and 0.25-μg (if required), 0.5-μg, 1-μg and 2-μg (if required) in 6 to 35 months old infants/toddlers.

Conditions

  • Enterovirus Infections

Interventions

BIOLOGICAL

EV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AIPO4] per dose)

Two vaccinations at 28 days apart

BIOLOGICAL

EV71 vaccine ([1 μg total protein + adjuvant 150 μg AIPO4] per dose)

Two vaccinations at 28 days apart

BIOLOGICAL

EV71 vaccine ([2 μg total protein + adjuvant 150 μg AIPO4] per dose)

Two vaccinations at 28 days apart

BIOLOGICAL

EV71 vaccine (2 μg total protein per dose)

Two vaccinations at 28 days apart

BIOLOGICAL

EV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AIPO4] per dose)

Two vaccinations at 28 days apart

BIOLOGICAL

EV71 vaccine ([1 μg total protein + adjuvant 150 μg AIPO4] per dose)

Two vaccinations at 28 days apart

BIOLOGICAL

EV71 vaccine (1 μg total protein per dose)

Two vaccinations at 28 days apart

Sponsors & Collaborators

  • Enimmune Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02777411 on ClinicalTrials.gov