Status:
COMPLETED
Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects
Lead Sponsor:
Seqirus
Conditions:
Influenza
Human
Eligibility:
All Genders
6-47 years
Phase:
PHASE3
Brief Summary
This phase 3 clinical study is a randomized, observer-blind, comparator-controlled, multicenter study of QIVc versus a US-licensed comparator QIV in children 6 months through 47 months of age. The pur...
Eligibility Criteria
Inclusion
- Individuals of 6 through 47 months of age on the day of informed consent.
- Individuals whose parent(s)/Legally Acceptable Representative (LAR) have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
- Individuals who can comply with study procedures including follow-up
- Individual is in generally good health as per the Investigator's medical judgement
Exclusion
- Acute (severe) febrile illness
- History of any anaphylaxis, serious vaccine reactions or hypersensitivity, including allergic reactions, to any component of vaccine or medical equipment whose use is foreseen in this study
- A known history of Guillain-Barre Syndrome or other demyelinating diseases such as encephalomyelitis and transverse myelitis
- 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
- Received influenza vaccination or has had documented influenza disease in the last 6 months prior to informed consent.
Key Trial Info
Start Date :
September 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 3 2020
Estimated Enrollment :
2414 Patients enrolled
Trial Details
Trial ID
NCT04074928
Start Date
September 6 2019
End Date
September 3 2020
Last Update
January 12 2022
Active Locations (47)
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1
84035 CCR Research
Mobile, Alabama, United States, 36608
2
84040 Southland Clnical Research Center
Anaheim, California, United States, 92804
3
84044 Premier Health Research Center
Downey, California, United States, 90240
4
84028 Orange County Research Institute
Ontario, California, United States, 91763