- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05184387
A Prospective Epidemiological Cohort Study Evaluating Occurrences of Influenza-like Illness.
July 14, 2022 updated by: Osivax
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.
Study Overview
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 Type
Observational
Enrollment (Actual)
66
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Ghent, Belgium, 9000
- Centre for Vaccinology (CEVAC)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Healthy subjects, men and women aged 18 to 55 years.
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Prospective epidemiological cohort
Urban and suburban population of healthy subjects aged 18-55 years, not vaccinated against influenza
|
Collection of blood samples and completion of an electronic Diary (eDiary)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of overall subjects reporting Influenza-Like-Illness cases as per Flu-PRO® questionnaire.
Time Frame: Through study completion, an average of 8 months.
|
Through study completion, an average of 8 months.
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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.
|
Through study completion, an average of 8 months.
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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.
|
Through study completion, an average of 8 months.
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Severity scores of overall Influenza-Like-Illness cases as per Flu-PRO® questionnaire.
Time Frame: Through study completion, an average of 8 months.
|
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.
|
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.
|
Through study completion, an average of 8 months.
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Duration of overall Influenza-Like-Illness cases as per Flu-PRO® questionnaire.
Time Frame: Through study completion, an average of 8 months.
|
Through study completion, an average of 8 months.
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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.
|
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.
|
Through study completion, an average of 8 months.
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Anti-NP immunoglobulin G (IgG) titers by ELISA at each time point.
Time Frame: Through study completion, an average of 8 months.
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Through study completion, an average of 8 months.
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Symptomatic and asymptomatic flu cases based on the abovementioned variables/parameters.
Time Frame: Through study completion, an average of 8 months.
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Through study completion, an average of 8 months.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 1, 2021
Primary Completion (ACTUAL)
July 12, 2022
Study Completion (ACTUAL)
July 12, 2022
Study Registration Dates
First Submitted
November 26, 2021
First Submitted That Met QC Criteria
January 7, 2022
First Posted (ACTUAL)
January 11, 2022
Study Record Updates
Last Update Posted (ACTUAL)
July 19, 2022
Last Update Submitted That Met QC Criteria
July 14, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OVX-FLU-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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