A trial to evaluate the immunogenicity and safety of a vaccine against influenza at two dose levels (300µg and 480 µg) compared to the vaccin at 180µg and placebo in healthy volunteers between 18 and 55 years and in healthy subjects aged 65 years and older.
- Conditions
- The study is being conducted in healthy volunteers for the prophylaxis of influenza infection.MedDRA version: 21.1Level: PTClassification code 10059429Term: Influenza immunisationSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2021-002535-39-BE
- Lead Sponsor
- Osivax
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 238
1.Written informed consent.
2.Healthy male or female subjects, as determined by medical history and medical examination.
3.Between the ages of 18 and 55 years, inclusive, in the pilot phase and the first, younger age cohort; aged 65 years and older in the second, older age cohort.
4.Subject who has fully been vaccinated with licensed SARS-CoV-2 (COVID-19) vaccine(s) according to national recommendations for the corresponding population group.
5.Reliable and willing to make themselves available for the duration of the study, and willing and able to follow study procedures.
6.Ability and technical possibility for completing an e-diary and e-PRO in the pilot phase and the first, younger age cohort; ability for completing a paper diary in the second, older age cohort.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 138
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
1.Subjects with a body mass index (BMI) =19 kg/m² or =35 kg/m² on the day of vaccination
2.In the pilot phase and the first younger age cohort only: Previous influenza vaccination within 6 months before the day of vaccination or planned to receive during the study duration.
3.Any known or suspected immunodeficient conditions.
4.Past or current history of significant autoimmune diseases, as judged by the Investigator.
5.Current history of uncontrolled medical illness such as diabetes, hypertension, heart, renal or hepatic diseases.
6.Known or suspected infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV).
7.Female subjects: pregnant, breast-feeding or of childbearing potential without appropriate contraceptive methods in place for 2 months before enrolment, or with positive pregnancy test on the day of vaccination. Appropriate contraceptive methods are to be maintained until the end of the trial.
8.Having received another vaccination within 3 months prior to the day of study vaccination for live attenuated vaccines, or within 1 month prior to the day of study vaccination for inactivated vaccines, except COVID-19 vaccine.
9.Planning to receive other vaccines during the first 28 days following the study vaccine administration, except COVID-19 vaccine.
10.Administration of any investigational or non-registered drug or vaccine within 3 months prior to the administration of study vaccines, or planned administration of any such product during the whole study period.
11.History of receiving blood, blood components or immunoglobulins within 3 months prior to the day of vaccination, or planned to receive such product during the whole study period.
12.Presence of an acute febrile illness on the day of vaccination (oral temperature >38.0°C, temporary exclusion criterion).
13.Past or current history of any progressive or severe neurological disorder, seizure disorder or Guillain-Barré syndrome.
14.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.
15.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.
16.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 anti-inflammatory drugs, interferon, immunomodulators, allergy shots, as judged by the Investigator.
17.History of severe allergic reactions and/or anaphylaxis, or serious adverse reactions to vaccines or allergy to kanamycin.
18.Any contraindication to IM administration, as judged by the Investigator.
19.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.
20.Sponsor employees or Investigator site personnel directly affiliated with this study, and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted, including children of newly composed families.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method