Phase 3 Safety and Immunogenicity Study of aQIV in Elderly Adults
Condition: Influenza, Human
MeSH terms: Influenza, Human
Intervention: MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV); Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1); MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine Containing the Alternate B Strain (aTIV-2)
Intervention description: The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for quadrivalent vaccines.; The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines.; The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines except the B strain present in this vaccine is the second/alternate B strain recommended for inclusion in quadrivalent vaccines (ie, Alternate B strain).
Intervention MeSH terms: Vaccines; MF59 oil emulsion
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: The trial is designed as a double-blind study
Enrollment: 1778.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This phase 3 study is a randomized, double-blinded, comparator controlled, parallel-group,
      multicenter study of aQIV versus the US-licensed 2017-2018 adjuvanted trivalent influenza
      vaccine (aTIV-1, Fluad), and versus an adjuvanted trivalent influenza vaccine (aTIV-2),
      containing the alternate B strain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females ≥ 65 years old who are healthy or have co-morbidities

          -  Individuals who or whose legal representative(s) have voluntarily given written
             consent after the nature of the study has been explained according to local regulatory
             requirements, prior to study entry

          -  Ability to attend all scheduled visits and to comply with study procedures including
             diary card completion and follow-up

        Exclusion Criteria:

          -  History of behavioral or cognitive impairment or psychiatric condition

          -  Hypersensitivity, including allergy, to any component of vaccines, medicinal products
             or medical equipment whose use is foreseen in this study

          -  Abnormal function of the immune system

          -  Receipt of any influenza vaccine within 6 months prior to enrollment in this study, or
             plan to receive influenza vaccine prior to the Day 22 blood collection

          -  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

        Additional eligibility criteria may be discussed by contacting the site.