Immunity to influenza virus disease and safety of Vaxigrip Tetra® (commercial vaccine with protection against 4 types of influenza virus) in participants 60 years and older

Phase 1

• Conditions: Influenza; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2021-003307-18-BE
• Lead Sponsor: niversity of Antwerp

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-21
• Last Update Posted: 3 November 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Eligible participants must meet all of the below criteria at the time of enrolment:
1.Male or female of non-child bearing potential 60 years and above at the time of study
2.Provide written informed consent.
3.The participant is willing to comply with study protocol requirements, including availability for all scheduled visits of the study.
4.Subjects are healthy or with well-controlled pre-existing medical conditions by the opinion of the investigator

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 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

Participants meeting any of the below criteria at the time of enrolment will be ineligible to participate in the trial:
1.Acute illness, at the time of study vaccine administration (once acute illness is resolved, if appropriate, as per investigator assessment, participant will be re-revaluated for eligibility).
2.Recorded fever (for eligibility purpose defined as a body temperature greater than 37.5°C) within 3 days prior to study vaccine administration (once fever/acute illness is resolved, if appropriate, as per investigator assessment, participant will be re-evaluated for eligibility.
3.Not willing to refrain from physical exercise during 48 hours prior to vaccination
4.History of any influenza vaccine administration during the past 6 months and during study participation.
5.Current or previous, laboratory confirmed case of influenza during the past 6 months, based on anamnesis or medical file (if available) at screening visit
6.Household contact with and/or intimate exposure to an individual with any laboratory confirmed influenza infection during the past 6 months prior to vaccination.
7.History of severe allergic reactions after previous vaccinations or hypersensitivity to any study vaccine component
8.Previous history of Guillain Barre Syndrome.
9.Any confirmed or suspected condition with impaired/altered function of immune system (e.g. immunodeficient or autoimmune conditions).
10.Having tested positive for Human Immuno-deficiency Virus (HIV), Hepatitis B or Hepatitis C on the blood tests of the screening visit
11.Having any bleeding disorder which is considered as a contraindication to intramuscular injection or blood draw according to the opinion of the investigator
12.Chronic administration (defined as more than 14 days) of immunosuppressant or other immune-modifying drugs within three months prior to the study vaccination or planned use throughout the study period. (For corticosteroids, this means prednisone, or equivalent, = 0.5 mg/kg per day. Inhaled, intranasal and topical steroids are allowed.
13.Neoplastic disease or any hematologic malignancy (except localized skin or prostate cancer that is stable at the time of vaccination in the absence of therapy and subjects who have a history of neoplastic disease and have been disease-free for =5 years).
14.Administration of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 3 months or planned use throughout the study period.;
15.Administration of any vaccine within 28 days prior to enrolment in the study (except for influenza vaccine which should be >6 months prior to enrollment) or planned administration of any vaccine during study participation.
16.Use of any investigational or non-registered drug or vaccine within 30 days prior to the administration of study vaccines or planned during the study.
17.Having received systemic antibiotic treatment within 3 days prior to enrolment.
18.Acute or chronic, clinically significant pulmonary, cardiovascular, metabolic, neurological, hepatic, or renal functional abnormality, as determined by medical history or physical examination if uncontrolled or without appropriate treatment
19.Any other condition that in the opinion of the investigator would jeopardize the safety or rights of the volunteer participating in the study or make it unlikely that the participant could complete the protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified