Influenza, HumanNANOVAXNCT00558649
A Pilot Study to Evaluate the Safety and Immunogenicity of Low Dose Flu Vaccines
A study testing Flu Vaccine (FLUARIX®) in people with Influenza, Human, run by NanoPass Technologies Ltd.
Trial summary
The purpose of this study is to determine whether low dose flu vaccines delivered with microneedles into the skin (intradermally) are effective. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Human
- What is being tested?
- Flu Vaccine (FLUARIX®)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- May 2007to Dec 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
None listed.
About this study
Official 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.
The purpose of this study is to determine whether low dose flu vaccines delivered with microneedles into the skin (intradermally) are effective.
Read the 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.
- Conditions
- Influenza, Human
- Being tested
- Flu Vaccine (FLUARIX®)
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flu Vaccine (FLUARIX®)Biological
Influenza Virus Vaccine, FLUARIX®, 2006-2007 Formula
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Low dose flu vaccine delivered intradermally using microneedles Receives: Biological: Flu Vaccine (FLUARIX®) |
| 2 | Experimental | Medium dose flu vaccine delivered intradermally using microneedles Receives: Biological: Flu Vaccine (FLUARIX®) |
| 3 | Active comparator | Standard dose flu vaccine delivered intramuscularly with a regular needle Receives: Biological: Flu Vaccine (FLUARIX®) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2007 (estimated)
- Study startMay 2007
- Primary completionSep 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza, HumanStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- NanoPass Technologies Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pierre Van Damme, MD, PhD, Principal investigator, Center for the Evaluation of Vaccination, University of Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00558649
- Sponsor's protocol ID
- NP39
- Other IDs
- EudraCT number 2007-001160-77
- Acronym
- NANOVAX
- Status last verified
- Nov 2007
- First submitted
- 27 May 2007
- Last updated
- 10 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT00558649
- Acronym / sponsor ID
- NANOVAX / NP39
- Conditions
- Influenza, Human
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- NanoPass Technologies LtdIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Sep 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 15 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Flu Vaccine (FLUARIX®)Low dose flu vaccine delivered intradermally using microneedles |
| 2 | Experimental | Biological: Flu Vaccine (FLUARIX®)Medium dose flu vaccine delivered intradermally using microneedles |
| 3 | Active comparator | Biological: Flu Vaccine (FLUARIX®)Standard dose flu vaccine delivered intramuscularly with a regular needle |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Signed an Informed Consent
- No previous immune-related disease
- Significant illness within the previous 4 weeks
- Subjects who have received an influenza vaccine within the previous 6 months
- An active viral diseases
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flu Vaccine (FLUARIX®)Influenza Virus Vaccine, FLUARIX®, 2006-2007 Formula | Biological | 1, 2, 3 |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Van Damme, MD, PhD principal investigator
Center for the Evaluation of Vaccination, University of Antwerp
Questions about this trial
What is this clinical trial studying?
A study testing Flu Vaccine (FLUARIX®) in people with Influenza, Human, run by NanoPass Technologies Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2013.