Safety and Immunogenicity of a Subunit Trivalent Nonadjuvated Influenza Study Vaccine in Adults Aged 18 Years and Above

Phase 1

• Conditions: MedDRA version: 15.1Level: PTClassification code 10022000Term: InfluenzaSystem Organ Class: 10021881 - Infections and infestations; Influenza; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2013-000545-39-BE
• Lead Sponsor: ovartis Vaccines and Diagnostics S.r.l.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-29
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

In order to participate in this study, a subject must meet ALL of the following inclusion
criteria:
? Is a male or female volunteer ages 18 years or older, mentally competent, willing
and able to give written informed consent prior to study entry;
? Is able to comply with all the study requirements; and
? Is in good health as determined by the outcome of medical history, physical
examination, and clinical judgment 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 63
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 63

Exclusion Criteria

In order to participate in this study, a subject must not meet any of the following exclusion criteria:
? Has 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;
? Has a serious chronic or acute disease (in the judgment of the investigator) including, but not limited to
- medically significant cancer (except for benign or localized skin cancer, cancer in remission for =10 years, or localized prostate cancer that has been clinically stable for >2 years without treatment)
- medically significant advanced congestive heart failure (ie, New York Heart Association [NYHA] class III and IV)
- chronic obstructive pulmonary disease (ie, Global initiative for chronic Obstructive Lung Disease [GOLD] stage III and IV)
- autoimmune disease (including rheumatoid arthritis and excepting Hashimoto’s thyroiditis that has been clinically stable for =5 years)
- diabetes mellitus type I
- poorly controlled diabetes mellitus type II
- advanced arteriosclerotic disease
- history of underlying medical condition such as major congenital abnormalities requiring surgery, chronic treatment, or associated with developmental delay (eg, Down’s syndrome)
- acute or progressive hepatic disease
- acute or progressive renal disease
- severe neurological (especially Guillain–Barré syndrome) or psychiatric disorder
- severe asthma
? Has a history of any anaphylactic reaction and/or serious allergic reaction to any component of the study vaccine (see section 5.1);
? Has a known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age) resulting, for example, from:
- receipt of immunosuppressive therapy (any parenteral or oral corticosteroid or cancer chemotherapy/radiotherapy) within the past 60 days and for the full length of the study,
- receipt of immunostimulants within the past 6 months,
- receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivates within the past 3 months and for the full length of the study, or
- suspected or known human immunodeficiency virus (HIV) infection or HIV related disease
? Has known or suspected drug or alcohol abuse within the past 2 years;
? Has bleeding diathesis or conditions associated with prolonged bleeding time that, in the investigator’s opinion, would interfere with the safety of the subject;
? Is not able to comprehend and to follow all required study procedures for the whole period of the study;
? Has a history or any illness that, in the opinion of the investigator, would pose additional risk to the subjects because of participation in the study;
? Has the following within the past 6 months:
- had any laboratory confirmed seasonal or pandemic influenza disease
- received any seasonal or pandemic influenza vaccine
? Has received any other vaccine within 4 weeks prior to enrollment in this study or who are planning to receive any vaccine during the study;
? Has acute or chronic infections requiring antiviral therapy within the last 7 days;
? Has experienced fever (ie, body temperature [preferably oral] =38.0°C) within the last 3 days of intended study vaccination;
? Has been participating in any clinical trial with another investigational product 4 weeks prior to first study visit or intends to participate in another clinical study at any time during the conduct of

Study & Design

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