InfluenzaPhase 2NCT01014806
Evaluate the Safety and Immunogenicity of a Seasonal Influenza Virus-Like Particle (VLP) Vaccine in Older Adults
A Phase 2 study testing Influenza VLP Vaccine and TIV in people with Influenza, run by Novavax at 6 sites in United States.
Trial summary
To assess the tolerability and safety of a single injection of Influenza VLP Vaccine when administered intramuscularly (IM) at 15 µg and 60 µg HA per each strain. To assess the immunogenicity of Influenza VLP Vaccine administered at 15 µg and 60 µg HA per strain as measured by hemagglutination inhibition (HAI)… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Influenza VLP Vaccine and TIV
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 467 participants
- Where
- 6 sitesUnited States
- Study dates
- Nov 2009to May 2010
- Phase
- Phase 2
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male or female > 60 years of age at the time of the vaccination.
- Informed consent must be obtained from the subject prior to beginning any study specific procedures indicating that they understand the purpose of this study and are willing to adhere to the procedures described in this protocol.
- Available by telephone.
- Free of obvious health problems or chronic illnesses (i.e., recent exacerbation or acute episode of chronic illness in the last 3 months) as established by medical history, review of systems, and clinical examination before entering the study. This includes any mental condition that would interfere with subject self-assessment. Subjects with a pre-existing chronic disease will be allowed to participate if the disease is stable. Stable disease is defined as no new onset of exacerbation of pre-existing chronic disease 3 months prior to study vaccine injection.
Who cannot join
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
- Receipt of any other licensed influenza vaccines or investigational influenza vaccine within 6 months prior to enrollment in this study or expected receipt of any vaccination before the final immune response blood collection.
- History of hypersensitivity to any component of inactivated influenza vaccines, including egg or egg products, gelatin, or arginine.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine. The use of inhaled and nasal steroids will be permitted.
- Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination.
- Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or during the study.
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- Acute disease at the time of enrollment. Acute disease is defined as the presence of a moderate or severe illness with or without fever > 100.5F.
- Acute clinically significant pulmonary, including asthma, cardiovascular, hepatic or renal functional abnormality as determined by physical examination or laboratory screening tests.
- Major congenital defects that may increase the risk for influenza complications.
- History of any neurological disorders or seizures (with the exception of febrile seizures during childhood) related to an underlying immune disease or disorder, such as but not limited to: multiple sclerosis, lupus, Guillain-Barre syndrome. Other neurological disorders that are clinically mild and stable with medication, such as mild Parkinson's disease, will not be excluded.
- Any condition that in the opinion of the investigator would interfere with evaluation of the vaccine or interpretation of study results.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Research Across America
Dallas, Texas, 75234
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464
Universtity Clinical Research
Pembroke Pines, Florida, 33024
Brown University
Providence, Rhode Island, 02908
Mayo Clinic
Rochester, Minnesota, 55905
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229
About this study
Official title: A Phase 2a Randomized, Double-Blind, Active-Controlled Trial to Evaluate the Safety and Immunogenicity of a Trivalent Seasonal Influenza Virus-Like Particle (VLP) Vaccine (Recombinant) in Older Adults
- To assess the tolerability and safety of a single injection of Influenza VLP Vaccine when administered intramuscularly (IM) at 15 µg and 60 µg HA per each strain.
- To assess the immunogenicity of Influenza VLP Vaccine administered at 15 µg and 60 µg HA per strain as measured by hemagglutination inhibition (HAI) antibody titers to each of the component viral strains [A/Brisbane/59/2007 (H1N1); A/Brisbane/10/2007 (H3N2) and B/Brisbane/60/2008].
- Conditions
- Influenza
- Being tested
- Influenza VLP Vaccine, TIV
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza VLP VaccineBiological
Single dose; 0.5mL
TIVBiological
Trivalent Influenza Vaccine 15ug/strain, commercially licensed
| Study group | Role | What they receive |
|---|---|---|
| Low dose | Experimental | Not described Receives: Biological: Influenza VLP Vaccine |
| High dose | Experimental | Investigational Influenza VLP Vaccine 60ug/strain Receives: Biological: Influenza VLP Vaccine |
| TIV | Active comparator | Trivalent Influenza Vaccine 15ug/strain, Commercially Licenced Receives: Biological: TIV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AEs)
Measured: 0-21 days
Immunogenicity by HAI
Measured: 21 Days
Secondary outcomes (3)
Immunogenicity by HAI compared to commercially licensed TIV vaccine
Measured: 21 days
Immunogenicity Against drifted strains by HAI
Measured: 21 days
Immunogenicity by neuraminidase activity inhibition (NAI)
Measured: 21 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 467 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novavax
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01014806
- Sponsor's protocol ID
- NVX755.202
- Status last verified
- Jul 2013
- First submitted
- 14 Nov 2009
- Last updated
- 18 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a Randomized, Double-Blind, Active-Controlled Trial to Evaluate the Safety and Immunogenicity of a Trivalent Seasonal Influenza Virus-Like Particle (VLP) Vaccine (Recombinant) in Older Adults
- ClinicalTrials.gov ID
- NCT01014806
- Acronym / sponsor ID
- NVX755.202
- Conditions
- Influenza
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 467 participants (actual)
- Lead sponsor
- NovavaxIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 17 Nov 2009 (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.
- To assess the tolerability and safety of a single injection of Influenza VLP Vaccine when administered intramuscularly (IM) at 15 µg and 60 µg HA per each strain.
- To assess the immunogenicity of Influenza VLP Vaccine administered at 15 µg and 60 µg HA per strain as measured by hemagglutination inhibition (HAI) antibody titers to each of the component viral strains [A/Brisbane/59/2007 (H1N1); A/Brisbane/10/2007 (H3N2) and B/Brisbane/60/2008].
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose | Experimental | Biological: Influenza VLP Vaccine |
| High dose | Experimental | Biological: Influenza VLP VaccineInvestigational Influenza VLP Vaccine 60ug/strain |
| TIV | Active comparator | Biological: TIVTrivalent Influenza Vaccine 15ug/strain, Commercially Licenced |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy male or female > 60 years of age at the time of the vaccination.
- Informed consent must be obtained from the subject prior to beginning any study specific procedures indicating that they understand the purpose of this study and are willing to adhere to the procedures described in this protocol.
- Available by telephone.
- Free of obvious health problems or chronic illnesses (i.e., recent exacerbation or acute episode of chronic illness in the last 3 months) as established by medical history, review of systems, and clinical examination before entering the study. This includes any mental condition that would interfere with subject self-assessment. Subjects with a pre-existing chronic disease will be allowed to participate if the disease is stable. Stable disease is defined as no new onset of exacerbation of pre-existing chronic disease 3 months prior to study vaccine injection.
Key exclusion criteria (11 listed)
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
- Receipt of any other licensed influenza vaccines or investigational influenza vaccine within 6 months prior to enrollment in this study or expected receipt of any vaccination before the final immune response blood collection.
- History of hypersensitivity to any component of inactivated influenza vaccines, including egg or egg products, gelatin, or arginine.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine. The use of inhaled and nasal steroids will be permitted.
- Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination.
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 |
|---|---|---|
| Influenza VLP VaccineSingle dose; 0.5mL | Biological | High dose, Low dose |
| TIVTrivalent Influenza Vaccine 15ug/strain, commercially licensed | Biological | TIV |
Primary outcome
Adverse Events (AEs)
Time frame: 0-21 days
Immunogenicity by HAI
Time frame: 21 Days
3 secondary outcomes
Immunogenicity by HAI compared to commercially licensed TIV vaccine
Time frame: 21 days
Immunogenicity Against drifted strains by HAI
Time frame: 21 days
Immunogenicity by neuraminidase activity inhibition (NAI)
Time frame: 21 Days
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 18 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Influenza VLP Vaccine and TIV in people with Influenza, run by Novavax at 6 sites in United States.
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 4 inclusion and 11 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 18 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
Adverse Events (AEs) (time frame: 0-21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 18 Jul 2013.