A Pilot Study to Evaluate the Safety and Immunogenicity o... | NCT00558649

Studies
A Pilot Study to Evaluate the Safety and Immunogenicity of Low Dose Flu Vaccines

NCT00558649

Sponsor

NanoPass Technologies Ltd

Status

Completed

Last Update Posted

May 10, 2013Estimated

Enrollment

180Actual

Phase

Not Applicable

Conditions

Influenza, Human

Interventions

Flu Vaccine (FLUARIX®)

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EudraCT number 2007-001160-77

Status Module

Record Verification Date

Nov 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2007

Primary Completion Date

Sep 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

May 27, 2007

First Submission Date that Met QC Criteria

Nov 14, 2007

First Posted Date

Nov 15, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 8, 2013

Last Update Posted Date

May 10, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine whether low dose flu vaccines delivered with microneedles into the skin (intradermally) are effective.

Detailed Description

Influenza vaccination is the primary method for preventing influenza and its severe complications. Previous clinical studies demonstrated that delivery of vaccines intradermally (into the skin) can achieve good efficacy even with lower doses of the vaccine.

Comparison: Low dose flu vaccine delivered intradermally with a microneedle device compared to the standard dose flu vaccine delivered intramuscularly (into the muscle) with a regular needle.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

180Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Low dose flu vaccine delivered intradermally using microneedles	Biological: Flu Vaccine (FLUARIX®)
2	Experimental	Medium dose flu vaccine delivered intradermally using microneedles	Biological: Flu Vaccine (FLUARIX®)
3	Active Comparator	Standard dose flu vaccine delivered intramuscularly with a regular needle	Biological: Flu Vaccine (FLUARIX®)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Flu Vaccine (FLUARIX®)	Biological	Influenza Virus Vaccine, FLUARIX®, 2006-2007 Formula	1 2 3

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed an Informed Consent
No previous immune-related disease

Important Exclusion Criteria:

Significant illness within the previous 4 weeks
Subjects who have received an influenza vaccine within the previous 6 months
An active viral diseases
Pregnant or nursing women
Any known contraindication to the study vaccine or vaccine ingredients

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pierre Van Damme, MD, PhD	Center for the Evaluation of Vaccination, University of Antwerp	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007251	Influenza, Human

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D009976	Orthomyxoviridae Infections
D012327	RNA Virus Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007252	Influenza Vaccines
C510903	fluarix

Ancestor Terms

ID	Term
D014765	Viral Vaccines
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures

Browse Leaves

Not provided

Browse Branches

Not provided