View clinical trials related to Influenza Immunisation.
Filter by:This was a Phase IV open label and single arm study, with the aim of enrolling up to 55 healthy males and non-pregnant females in a single site, age 18-49 years old, inclusive. This study was designed to assess the humoral response to influenza vaccination and the longevity of humoral immunity to influenza vaccination in healthy adults. Total enrollment was 27 participants. This was a multi-year study. After one year of participation, participants were offered the opportunity to participate in the study for up to 3 consecutive years, provided eligibility criteria was met each year. Participants who elected to continue in the study after first year of participation were rescreened to verify continued eligibility and re-consented prior to subsequent participation. The primary study objective was to investigate the longevity of humoral immunity to influenza virus in humans. Note: Due to the Coronavirus Disease of 2019 (COVID-19) pandemic, all non-essential research was halted in mid-March 2020. New enrollments were placed on hold for this study. Follow-up visits were also halted, which impacted the timing of participants' subsequent follow-up visits. Participant visits for Day 7 and Day 14 were not impacted. For this study, there were participants whose Day 28 and Day 90 visits were impacted by the temporary halting of non-essential research studies. As such, a request was submitted to the Emory University Institutional Review Board to extend the missed visit windows for the Day 28 and Day 90 visits for a maximum of up to 180 days, to ensure that ample time was available to bring participants back for their missed visits. Enrollment for this study ended on March 31, 2020, before research activities could resume at Emory.
This was an open label, single arm, Phase IV study of longitudinal immunologic responses to influenza vaccine in healthy adult participants, with the aim of enrolling up to 70 participants. This study enrolled males and non-pregnant females, 18-49 years old, inclusive. The participants were screened at enrollment with a history and physical exam and laboratory testing to ensure they were healthy enough to participate. Total enrollment was 60 participants. Qualifying participants were vaccinated with an FDA approved seasonal inactivated influenza vaccine (IIV) according to the package insert. The study enrolled a total 60 participants. The primary objective of the study was to characterize HA-specific plasmablasts and memory B cells after influenza vaccination. Note: Due to the Coronavirus Disease 2019 (COVID-19) pandemic, all non-essential research was halted in mid-March 2020. New enrollments were placed on hold for this study. Follow-up visits were also halted, which impacted the timing of participants' subsequent follow-up visits. Five participants had their Day 180 visits halted due to the COVID-19 pandemic.