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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Influenza, Human Infections Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Flu Vaccine (FLUARIX®)

Biological

Influenza Virus Vaccine, FLUARIX®, 2006-2007 Formula

Sponsors and collaborators

Lead sponsor

NanoPass Technologies Ltd

Industry

Registry information

Official study title

A Pilot, Controlled, Comparative and Single Blinded Study to Evaluate the Safety and Immunogenicity of Low Dose Flu Vaccines Administered Intradermally Using Microneedle Injectors as Compared With Standard Dose Intramuscular Flu Vaccines as Reference.

Acronym: NANOVAX

Important dates

Study start: 2007
Primary completion: 2007
Study completion: 2007
First posted: Nov 15, 2007
Registry last updated: May 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed