MedTrace Logo

Safety and Immunogenicity Study of an Inactivated Vaccine Against Hand, Foot and Mouth Disease Caused by Enterovirus 71

NCT01376479 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2015-05-06

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and immune response of an inactivated vaccine to prevent hand, foot and mouth disease (HFMD) caused by Enterovirus 71 (EV71).

Conditions

  • Hand, Foot and Mouth Disease

Interventions

BIOLOGICAL

INV21 Low Dose

Inactivated EV71 vaccine containing whole viral particles of EV71 formulated with aluminum hydroxide.

BIOLOGICAL

INV21 High Dose

Inactivated EV71 vaccine consisting of whole viral particles of EV71 formulated with aluminum hydroxide.

BIOLOGICAL

Placebo

Phosphate Buffered Saline (PBS)

Sponsors & Collaborators

  • Inviragen Inc.

    lead INDUSTRY

Principal Investigators

  • Paul A Tambyah, MBBS · Department of Medicine, National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2011-11-30
Completion
2012-04-30

Countries

  • Singapore

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 NCT01376479 on ClinicalTrials.gov