Clinical Study in Elderly to Evaluate the Safety, Immunogenicity and Efficacy of Investigational Flu Vaccine Compared to an Approved non-Flu Vaccine

Phase 1

• Conditions: Profylaxis for Influenza virus; MedDRA version: 20.0Level: PTClassification code 10022000Term: InfluenzaSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2015-000728-27-PL
• Lead Sponsor: Seqirus UK Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-18
• Last Update Posted: 6 November 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 10692

Inclusion Criteria

1.Males and females = 65 years old who are healthy or have co-morbidities
2.Individuals who or whose legal guardian have voluntarily given written consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
3. Ability to attend all scheduled visits and to comply with study procedures including follow-up (and responding to messages and telephone contact).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10692

Exclusion Criteria

1.Receipt of diphtheria or tetanus toxoid or pertussis (acellular or whole cell) vaccines within the previous 5 years.
2.History of behavioral or cognitive impairment or psychiatric condition that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study.
3.History of any medical condition considered an adverse event of special interest, see Section 7.1.4.1, Adverse Events of Special Interest.
4.Progressive or severe neurological disorder, seizure disorder, or history of Guillain-Barré syndrome.
5.Hypersensitivity, including allergy, to any component of vaccines see Table 6.1-1 and Table 6.1-2 , medicinal products or medical equipment whose use is foreseen in this study.
6.Encephalopathy (e.g. coma, decreased level of consciousness, prolonged seizures) within 7 days of administration of a previous pertussis antigen-containing vaccine.
7.Clinical conditions representing a contraindication to intramuscular vaccination and blood draws, including bleeding diathesis, or any other condition that may be associated with prolonged bleeding.
8.Abnormal function of the immune system resulting from:
a.Clinical conditions.
b.Systemic administration of corticosteroids (PO/IV/IM) at a dose equivalent to 20 mg of prednisone for more than 14 consecutive days within 90 days prior to informed consent.
c.Administration of antineoplastic and immunomodulating agents (e.g. TNF a antagonists or anti-B cell antibodies) or radiotherapy within 1 year prior to informed consent.
9.Receipt of immunoglobulins or any blood products within 180 days prior to informed consent.
10.Receipt of an investigational or non-registered medicinal product within 30 days prior to informed consent or before completion of the safety follow-up period in another study and who are unwilling to refuse participation in another clinical study at any time during the conduct of this study (note: concomitant participation in an observational study not involving drugs, vaccines, or medical devices, is acceptable).
11.Study personnel or immediate family members (brother, sister, child, parent), the spouse of study personnel or individuals who are financially or emotionally dependent on study staff.
12.Receipt of any influenza vaccine within 6 months prior to enrolment in this study or who plan to receive influenza vaccine while participating in the study.
13.Receipt of any inactivated vaccine 14 days or live-attenuated vaccine 28 days prior to enrolment in this study or who are planning to receive any vaccine within 28 days from study vaccination.
14.Fever at the time of screening, defined as oral temperature =38.0 degrees Celsius (= 100.4° F). Enrolment could be considered if fever is absent for 72 hours.
15.Signs or symptoms of acute respiratory tract infection at the time of screening. Enrolment could be deferred if signs and symptoms are absent for 72 hours.
16.Residence in a chronic care facility (e.g. nursing home).
17.Participation in this trial in a prior season, if applicable.
18.Fatal prognosis of an underlying medical condition (<12 months life expectancy).
19. Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study.

Study & Design

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