CSL Limited Influenza Virus Vaccine (Afluria®)
BiologicalA single 0.5 mL, intramuscular injection in the deltoid region of the arm on day 0.
NCT Number: NCT00735475
The purpose of this study is to determine the immunogenicity and safety profile of CSL Limited's Influenza Virus Vaccine compared to a US Licensed Comparator Influenza Virus Vaccine.
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Notify Me65 year and older
All sexes
Interventional
Phase 4
North Central Arkansas Medical Association, Mountain Home, Arkansas, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A single 0.5 mL, intramuscular injection in the deltoid region of the arm on day 0.
A single 0.5 mL, intramuscular injection in the deltoid region of the arm on day 0.
Time frame: 21 days after vaccination
Time frame: 21 days after vaccination
Seroconversion rate was defined as the proportion of participants with a HI titer of less than 1:10 before vaccination achieving a HI antibody titer of 1:40 or more after vaccination, or with a HI titer of 1:10 or more before vaccination achieving a four-fold or greater increase in HI titer after vaccination.
Time frame: 5 days after vaccination
Time frame: 5 days after vaccination
Time frame: 21 days after vaccination
Abbreviation UAE stands for Unsolicited Adverse Event.
Time frame: 180 days after vaccination
Time frame: 180 days after vaccination
A NOCI was defined as the diagnosis of a chronic medical condition where the symptoms commenced or worsened following exposure to the study vaccine and may have included those potentially controllable by medication (e.g., glaucoma, hypertension).
Seqirus
Industry
A Phase IV, Randomized, Observer-Blind, Multi-Center, Non Inferiority Comparison of the Immune Response of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Inactivated Split-Virion Influenza Vaccine in Adults Aged Greater Than or Equal to 65 Years
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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