Status:
COMPLETED
Phase 3 Safety and Immunogenicity Study of aQIV in Elderly Adults
Lead Sponsor:
Seqirus
Conditions:
Influenza, Human
Eligibility:
All Genders
65+ years
Phase:
PHASE3
Brief 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, Fl...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 17 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 17 2018
Estimated Enrollment :
1778 Patients enrolled
Trial Details
Trial ID
NCT03314662
Start Date
October 17 2017
End Date
May 17 2018
Last Update
July 22 2020
Active Locations (20)
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1
Coastal Clinical Research, Inc.
Mobile, Alabama, United States, 36608
2
Anaheim Clinical Trials
Anaheim, California, United States, 92801
3
Paradigm clinical Research Centers, Inc
Redding, California, United States, 96001
4
Clinical Research of South Florida, an AMR Company
Coral Gables, Florida, United States, 33134