Seasonal InfluenzaPhase 2NCT00903552
Trial to Evaluate Safety and Immunogenicity of Trivalent Seasonal Influenza Virus-Like Particle (VLP) Vaccine (Recombinant)
A Phase 2 study testing Influenza VLP Vaccine in people with Seasonal Influenza, run by Novavax at 2 sites in United States.
Trial summary
This is a phase 2A randomized, double blind, placebo controlled trial to evaluate the safety and immunogenicity of a trivalent seasonal influenza virus-like particle (VLP) vaccine (recombinant) in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Seasonal Influenza
- What is being tested?
- Influenza VLP Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 221 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2009to Oct 2009
- 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 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female 18 to 49 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 (Novavax, Inc. CONFIDENTIAL 22 Apr2009; NVX 755.203 Version 2.0 Page 22 of 52)
- Free of obvious health problems or chronic illnesses (i.e., recent exacerbation or acute episode of chronic illness in the last 6 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 (such as but not limited to hypertension, diabetes, hypothyroidism) 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 6 months prior to study vaccine injection)
- If subject is of childbearing potential, she must be abstinent or have used adequate contraceptive precautions (e.g., intrauterine contraceptive device; oral contraceptives or other equivalent hormonal contraception) for 2 months prior to vaccination. She must also have a negative pregnancy test at study entry and must agree to continue such precautions for three months after vaccination
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
- Has received any other licensed or investigational influenza vaccine within 12 months prior to enrollment in this study or expected receipt of any influenza vaccination before the final immune response blood collection
- 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
Show all 13Show fewer
- Acute disease at the time of enrollment. Acute disease is defined as the presence of a moderate or severe illness with or without fever > 100.5°F
- Acute clinically significant pulmonary (e.g., asthma), cardiovascular, hepatic or renal functional abnormality as determined by physical examination or laboratory screening tests
- Major congenital defects
- History of any neurological disorders or seizures, with the exception of febrile seizures during childhood
- Pregnant or lactating female
- Females planning to become pregnant or planning to discontinue contraceptive precautions within 60 days of enrollment in this study
- 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
2 sites in 1 country.
United States2 sites
SNBL Clinical Pharmacology Center
Baltimore, Maryland, 21201
University Clinical Research, Inc.
Pembroke Pines, Florida, 33024
About this study
Official title: A Phase 2a Randomized, Double Blind, Placebo Controlled Trial to Evaluate the Safety and Immunogenicity of a Trivalent Seasonal Influenza Virus-Like Particle (VLP) Vaccine (Recombinant) in Healthy Adults
This is a phase 2A randomized, double blind, placebo controlled trial to evaluate the safety and immunogenicity of a trivalent seasonal influenza virus-like particle (VLP) vaccine (recombinant) in healthy adults.
Read the detailed description
The primary study objectives are:
- To assess the tolerability and safety of the Influenza VLP Vaccine
- To assess the immunogenicity of the Influenza VLP Vaccine as measured by hemagglutination inhibition (HAI) antibody titers to each of the component viral strains
- Conditions
- Seasonal Influenza
- Being tested
- Influenza VLP Vaccine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza VLP VaccineBiological
PlaceboBiological
phosphate-buffered saline (PBS)
| Study group | Role | What they receive |
|---|---|---|
| Low Dose | Experimental | Not described Receives: Biological: Influenza VLP Vaccine |
| PBS | Placebo comparator | Not described Receives: Biological: Placebo |
| High Dose | Experimental | Not described Receives: Biological: Influenza VLP Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the tolerability and safety of the Influenza VLP Vaccine
Measured: 10 days, 6 months
The Influenza VLP Vaccine will be immunogenic
Measured: 22 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2009 (estimated)
- Study startMay 2009
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal 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
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novavax
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nigel Thomas, Ph.D., Study director, Novavax, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00903552
- Sponsor's protocol ID
- NVX 755.203
- Status last verified
- Jul 2013
- First submitted
- 14 May 2009
- Last updated
- 18 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
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, Placebo Controlled Trial to Evaluate the Safety and Immunogenicity of a Trivalent Seasonal Influenza Virus-Like Particle (VLP) Vaccine (Recombinant) in Healthy Adults
- ClinicalTrials.gov ID
- NCT00903552
- Acronym / sponsor ID
- NVX 755.203
- Conditions
- Seasonal Influenza
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- NovavaxIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 18 May 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.
This is a phase 2A randomized, double blind, placebo controlled trial to evaluate the safety and immunogenicity of a trivalent seasonal influenza virus-like particle (VLP) vaccine (recombinant) in healthy adults.
Detailed description
The primary study objectives are:
- To assess the tolerability and safety of the Influenza VLP Vaccine
- To assess the immunogenicity of the Influenza VLP Vaccine as measured by hemagglutination inhibition (HAI) antibody titers to each of the component viral strains
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 |
| PBS | Placebo comparator | Biological: Placebo |
| High Dose | Experimental | Biological: Influenza VLP Vaccine |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy male or female 18 to 49 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 (Novavax, Inc. CONFIDENTIAL 22 Apr2009; NVX 755.203 Version 2.0 Page 22 of 52)
- Free of obvious health problems or chronic illnesses (i.e., recent exacerbation or acute episode of chronic illness in the last 6 months) as established by medical history, review of systems, and clinical examination before entering the study:
- If subject is of childbearing potential, she must be abstinent or have used adequate contraceptive precautions (e.g., intrauterine contraceptive device; oral contraceptives or other equivalent hormonal contraception) for 2 months prior to vaccination. She must also have a negative pregnancy test at study entry and must agree to continue such precautions for three months after vaccination
Key exclusion criteria (13 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
- Has received any other licensed or investigational influenza vaccine within 12 months prior to enrollment in this study or expected receipt of any influenza vaccination before the final immune response blood collection
- 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
- 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
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 Vaccine | Biological | High Dose, Low Dose |
| Placebophosphate-buffered saline (PBS) | Biological | PBS |
Primary outcome
To assess the tolerability and safety of the Influenza VLP Vaccine
Time frame: 10 days, 6 months
The Influenza VLP Vaccine will be immunogenic
Time frame: 22 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.
Related trials for Seasonal Influenza
RecruitingPhase 1
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Children
Seasonal Influenza
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
RecruitingPhase 1
Evaluating the Dose, Safety, Tolerability, and Immunogenicity of Mosaic Hexavalent Influenza Vaccine VRCFLUMOS0116-00-VP (FluMos-v2) With and Without ALFQ Adjuvant in Healthy Adults
Influenza Prevention, Seasonal Influenza
Not yet recruitingPhase 1
Phase I Clinical Trial of Trivalent Inactivated Split Influenza Virus Vaccine (MDCK Cell)
Seasonal Influenza
Not yet recruitingPhase 4
A Study of Updated mRNA Seasonal Influenza Vaccines
Seasonal Influenza
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.
Nigel Thomas, Ph.D. study director
Novavax, Inc.
2 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 in people with Seasonal Influenza, run by Novavax at 2 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 7 inclusion and 13 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 2 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. Some participants in this study may receive a placebo. 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?
To assess the tolerability and safety of the Influenza VLP Vaccine (time frame: 10 days, 6 months). 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.