Immunogenicity Trial of Egg- Versus Non-Egg-Based Influenza Vaccines Among HCP
Completed · Phase 4
Conditions studied: Influenza
In brief
This randomized, open-label trial will assess humoral and cell-mediated immune responses to cell culture-based and recombinant unadjuvanted quadrivalent influenza vaccines compared to conventional egg-based unadjuvanted quadrivalent standard dose (15µg of HA per strain) influenza vaccines among persons aged 18-64 years. The trial will be conducted at two sites in the United States during two influenza seasons (2018-19 and 2019-20). Stratified enrollment procedures will be used to enroll a mix of participants based on age.
Key facts
- Study ID
- NCT03722589
- Run by
- Centers for Disease Control and Prevention
- People needed
- 944
- Starts
- 2018-09-12
- Expected to finish
- 2020-07-31
- Last updated by the study team
- 2024-07-22
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Healthcare personnel (HCP) who have direct contact with patients, including dentists and other dental health personnel
- Enrolled in Scott \& White Healthcare or Kaiser Permanente health network for at least one month
- Aged 18-64 years for newly enrolled participants
- Aged 18-65 years for participants who were originally enrolled in year one of the study and return for year 2
- Available and willing to participate in study follow-up through the end of the 2019-2020 influenza season (i.e. at least approximately 18 months if enrolled during season 1 or 6 months if enrolled during season 2)
- Received an egg-based standard dose influenza vaccine during the 2018-2019 influenza season (for participants enrolled for the first-time during year two)
You may not qualify if…
- Already received an influenza vaccine during the current influenza season
- Previous hypersensitivity reaction to the study vaccines as reported by the subject
- Received any vaccine in the 4 weeks prior to the first study visit or plans to receive a vaccine (other than influenza vaccine provided through the study protocol) in the 4 weeks following the first study visit
- Currently participating in a study that involves an experimental agent (vaccine, drug, biologic, device, blood product, or medication), or has received an experimental agent within 1 month prior to enrollment in this study, or expects to receive an experimental agent during participation in this study
- Any condition that the principle investigator (PI) believes may interfere with successful completion of the study
Where it is running
- Kaiser Permanente Northwest — Portland, Oregon, United States
- Baylor Scott and White Health — Temple, Texas, United States
Full record on ClinicalTrials.gov
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