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A Study to Evaluate the Efficacy, Immunogenicity and Safety of an EV71 Vaccine in Healthy Infants and Children

NCT05099029 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3982

Last updated 2024-08-28

No results posted yet for this study

Summary

The objectives of this study are to evaluate the EV71vaccine efficacy, immune response and safety profiles after two injections of the cell culture-based inactivated EV71 vaccine with adjuvant Al(OH)3 administrated in pediatric population aged 2 months to 6 years old.

Conditions

  • Enterovirus Infections

Interventions

BIOLOGICAL

EV71 vaccine

EV71 vaccine (\[1 μg total protein + adjuvant 150 μg AI(OH)3\] per dose) Two vaccinations at 28 days apart

BIOLOGICAL

Placebo

Placebo (\[ adjuvant 150 μg AI(OH)3\] per dose) Two vaccinations at 28 days apart

Sponsors & Collaborators

  • Enimmune Corporation

    lead INDUSTRY

Principal Investigators

  • Chin-Fen Yang · Enimmune Corporation

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
71 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-27
Primary Completion
2024-08-30
Completion
2024-12-31

Countries

  • Taiwan
  • Vietnam

Study Locations

More Related Trials

Entities

Drugs

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 NCT05099029 on ClinicalTrials.gov