InfluenzaNCT05184387
A Prospective Epidemiological Cohort Study Evaluating Occurrences of Influenza-like Illness.
An observational study of Influenza, run by Osivax at 1 site in Belgium.
Trial summary
This Prospective epidemiological cohort study is being conducted in order to generate epidemiological data in support of Osivax's clinical development of a broad spectrum influenza vaccine based upon the internal influenza nucleoprotein (NP) as a target for immune response. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Blood samples
- Type of treatment
- Vaccines
- How many people
- 66 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Dec 2021to 12 Jul 2022
- Phase
- Observational
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy subjects, men and women aged 18 to 55 years.
Who may be able to join
- Written informed consent.
- Healthy male or female subjects, as determined by medical history and medical examination (as needed).
- Between the ages of 18 and 55 years, inclusive.
- Subject who has fully been vaccinated with licensed severe Acute Respiratory Syndrome SARS-CoV-2 (COVID-19) vaccine(s) according to national recommendations for the corresponding population group.
- Reliable and willing to make themselves available for the duration of the study, and willing and able to follow study procedures.
- Ability and technical possibility for completing an electronic Diary (eDiary) and electronic Flu-PRO® questionnaire (ePRO).
Who cannot join
- Previous influenza vaccination within 6 months before the day of enrollment or planned to receive during the study duration.
- Any known or suspected immunodeficient conditions.
- Current history of significant uncontrolled medical illness such as diabetes, hypertension, heart, renal or hepatic diseases, as judged by the Investigator.
- Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) to the subject's knowledge.
- Administration of any investigational or non-registered drug or vaccine within 3 months prior to enrollment, or planned administration of any such product during the whole study period.
- History of receiving blood, blood components or immunoglobulins within 3 months prior to the day of enrollment, or planned to receive such product during the whole study period.
Show all 10Show fewer
- Behavioral or cognitive impairment, or psychiatric disease that, in the opinion of the Investigator, may interfere with the subject's ability to participate in the study.
- Past (stopped less than 6 months before enrolment) or current history of alcohol or drug abuse, or current smoking habit above 10 cigarettes per day, or current vaping.
- Treatment that can affect immune response such as systemic or high dose inhaled corticosteroids (>800μg/day beclomethasone or equivalent; occasional inhaled corticosteroids for asthma therapy are allowed), radiation treatment, cytotoxic drugs, or current or recent (within 30 days before study entry) chronic or prolonged (>10 days) use of systemic non-steroidal antiinflammatory drugs, interferon, immunomodulators, allergy shots, as judged by the Investigator.
- Individuals with history of any illness that, in the opinion of the Investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Epidemiological Cohort Study Evaluating Occurrences of Influenza-like Illness in an Urban and Suburban Population of Healthy Subjects Aged 18-55 Years, Not Vaccinated Against Influenza.
This Prospective epidemiological cohort study is being conducted in order to generate epidemiological data in support of Osivax's clinical development of a broad spectrum influenza vaccine based upon the internal influenza nucleoprotein (NP) as a target for immune response.
Read the detailed description
The present study is being conducted in order to generate epidemiological data in support of Osivax's clinical development of a broad spectrum influenza vaccine based upon the internal influenza nucleoprotein (NP) as a target for immune response.
- Conditions
- Influenza
- Being tested
- Blood samples
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesOther
Collection of blood samples and completion of an electronic Diary (eDiary)
| Study group | Role | What they receive |
|---|---|---|
| Prospective epidemiological cohort | Urban and suburban population of healthy subjects aged 18-55 years, not vaccinated against influenza Receives: Other: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of overall subjects reporting Influenza-Like-Illness cases as per Flu-PRO® questionnaire.
Measured: Through study completion, an average of 8 months.
Proportion of subjects reporting Influenza-Like-Illness cases as per Flu-PRO® questionnaire with laboratory-confirmed influenza.
Measured: Through study completion, an average of 8 months.
Proportion of subjects reporting Influenza-Like-Illness cases as per Flu-PRO® questionnaire with non-laboratory-confirmed influenza.
Measured: Through study completion, an average of 8 months.
Severity scores of overall Influenza-Like-Illness cases as per Flu-PRO® questionnaire.
Measured: Through study completion, an average of 8 months.
Severity scores of Influenza-Like-Illness cases as per Flu-PRO® questionnaire with laboratory-confirmed influenza.
Measured: Through study completion, an average of 8 months.
Severity scores of Influenza-Like-Illness cases as per Flu-PRO® questionnaire with non-laboratory-confirmed influenza.
Measured: Through study completion, an average of 8 months.
Duration of overall Influenza-Like-Illness cases as per Flu-PRO® questionnaire.
Measured: Through study completion, an average of 8 months.
Duration of Influenza-Like-Illness cases as per Flu-PRO® questionnaire with laboratory-confirmed influenza.
Measured: Through study completion, an average of 8 months.
Duration of Influenza-Like-Illness cases as per Flu-PRO® questionnaire with non-laboratory-confirmed influenza.
Measured: Through study completion, an average of 8 months.
Anti-NP immunoglobulin G (IgG) titers by ELISA at each time point.
Measured: Through study completion, an average of 8 months.
Symptomatic and asymptomatic flu cases based on the abovementioned variables/parameters.
Measured: Through study completion, an average of 8 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start1 Dec 2021
- Primary completion12 Jul 2022
- Study completion12 Jul 2022
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osivax
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Ghent
- Responsible party
- Sponsor
- Investigators
- Isabel Leroux-Roels, MD, PhD, Principal investigator, Centre for Vaccinology (CEVAC), Ghent University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05184387
- Sponsor's protocol ID
- OVX-FLU-001
- Status last verified
- Jul 2022
- First submitted
- 26 Nov 2021
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Epidemiological Cohort Study Evaluating Occurrences of Influenza-like Illness in an Urban and Suburban Population of Healthy Subjects Aged 18-55 Years, Not Vaccinated Against Influenza.
- ClinicalTrials.gov ID
- NCT05184387
- Acronym / sponsor ID
- OVX-FLU-001
- Conditions
- Influenza
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- OsivaxIndustry (pharma, biotech, devices)
- Collaborators
- University Ghent
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 12 Jul 2022 (actual)
- Study completion
- 12 Jul 2022 (actual)
- First posted
- 11 Jan 2022 (actual)
- 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 Prospective epidemiological cohort study is being conducted in order to generate epidemiological data in support of Osivax's clinical development of a broad spectrum influenza vaccine based upon the internal influenza nucleoprotein (NP) as a target for immune response.
Detailed description
The present study is being conducted in order to generate epidemiological data in support of Osivax's clinical development of a broad spectrum influenza vaccine based upon the internal influenza nucleoprotein (NP) as a target for immune response.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective epidemiological cohort | – | Other: Blood samplesUrban and suburban population of healthy subjects aged 18-55 years, not vaccinated against influenza |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy subjects, men and women aged 18 to 55 years.
Key inclusion criteria (6 listed)
- Written informed consent.
- Healthy male or female subjects, as determined by medical history and medical examination (as needed).
- Between the ages of 18 and 55 years, inclusive.
- Subject who has fully been vaccinated with licensed severe Acute Respiratory Syndrome SARS-CoV-2 (COVID-19) vaccine(s) according to national recommendations for the corresponding population group.
- Reliable and willing to make themselves available for the duration of the study, and willing and able to follow study procedures.
Key exclusion criteria (10 listed)
- Previous influenza vaccination within 6 months before the day of enrollment or planned to receive during the study duration.
- Any known or suspected immunodeficient conditions.
- Current history of significant uncontrolled medical illness such as diabetes, hypertension, heart, renal or hepatic diseases, as judged by the Investigator.
- Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) to the subject's knowledge.
- Administration of any investigational or non-registered drug or vaccine within 3 months prior to enrollment, or planned administration of any such product during the whole study period.
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 |
|---|---|---|
| Blood samplesCollection of blood samples and completion of an electronic Diary (eDiary) | Other | Prospective epidemiological cohort |
Primary outcome
Proportion of overall subjects reporting Influenza-Like-Illness cases as per Flu-PRO® questionnaire.
Time frame: Through study completion, an average of 8 months.
Proportion of subjects reporting Influenza-Like-Illness cases as per Flu-PRO® questionnaire with laboratory-confirmed influenza.
Time frame: Through study completion, an average of 8 months.
Proportion of subjects reporting Influenza-Like-Illness cases as per Flu-PRO® questionnaire with non-laboratory-confirmed influenza.
Time frame: Through study completion, an average of 8 months.
Severity scores of overall Influenza-Like-Illness cases as per Flu-PRO® questionnaire.
Time frame: Through study completion, an average of 8 months.
Severity scores of Influenza-Like-Illness cases as per Flu-PRO® questionnaire with laboratory-confirmed influenza.
Time frame: Through study completion, an average of 8 months.
Severity scores of Influenza-Like-Illness cases as per Flu-PRO® questionnaire with non-laboratory-confirmed influenza.
Time frame: Through study completion, an average of 8 months.
Duration of overall Influenza-Like-Illness cases as per Flu-PRO® questionnaire.
Time frame: Through study completion, an average of 8 months.
Duration of Influenza-Like-Illness cases as per Flu-PRO® questionnaire with laboratory-confirmed influenza.
Time frame: Through study completion, an average of 8 months.
Duration of Influenza-Like-Illness cases as per Flu-PRO® questionnaire with non-laboratory-confirmed influenza.
Time frame: Through study completion, an average of 8 months.
Anti-NP immunoglobulin G (IgG) titers by ELISA at each time point.
Time frame: Through study completion, an average of 8 months.
Symptomatic and asymptomatic flu cases based on the abovementioned variables/parameters.
Time frame: Through study completion, an average of 8 months.
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 19 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Influenza
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
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.
Isabel Leroux-Roels, MD, PhD principal investigator
Centre for Vaccinology (CEVAC), Ghent University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza, run by Osivax at 1 site in Belgium.
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 6 inclusion and 10 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 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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.
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?
Proportion of overall subjects reporting Influenza-Like-Illness cases as per Flu-PRO® questionnaire. (time frame: Through study completion, an average of 8 months.). The study lists 11 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 19 Jul 2022.