Trials Sponsors Conditions Drugs Pricing

Conditions

Enterovirus 71 Human

Keywords

EV71 Vaccine

Outcome Measures

Primary Outcomes (1)

To evaluate overall safety of EV71 vaccine in children, throughout the study period
Occurrence of overall adverse events and serious adverse events during the entire period of study.
2 years after study initiation

Secondary Outcomes (1)

To evaluate immunogenicity, serum neutralizing antibody titers humoral immune response, induced by candidate vaccine
2 years from study initiation

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Phosphate Buffer Saline with adjuvant aluminium phosphate

Biological: Placebo

EV71 with adjuvant aluminium phosphate

EXPERIMENTAL

Inactive whole monovalent EV71 virion vaccine formulated with phosphate-buffered saline based adjuvanted aluminium phosphate 150 μg/0.5ml

Biological: EV71 with adjuvant aluminium phosphate

Interventions

EV71 with adjuvant aluminium phosphateBiological

Two arms, EV71 with aluminium phosphate

EV71 with adjuvant aluminium phosphate

PlaceboBiological

Phosphate Buffer Saline with adjuvant aluminium phosphate

Placebo

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age2 Months - 12 Years

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17)

You may qualify if:

Healthy children and infants aged from 2 months to less than 12 years as established by medical history and clinical examination
The subjects' guardians are able to understand and sign the informed consent

Sponsors & Collaborators

Medigen Vaccine Biologics Corp.
Industrylead

Study Sites (4)

Chang-Guang Memorial Hospital Lin-Kou

Taipei, Taiwan

Far Eastern Memorial Hospital

Taipei, Taiwan

MacKay Memorial Hospital

Taipei, Taiwan

National Taiwan University Hosptial

Taipei, Taiwan

Study Officials

Li-Min Huang, M.D., PhD.
National Taiwan University Hospital
PRINCIPAL INVESTIGATOR

Enrollment

366 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
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

July 18, 2014

First Posted

July 25, 2014

Study Start

September 2014

Date type not reported

This date has not been verified as actual or estimated.

A Clinical Study for Inactivated Vaccine Against EV71

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Placebo

EV71 with adjuvant aluminium phosphate

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Placebo

EV71 with adjuvant aluminium phosphate

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations