Phase 4
N=727
Immunogenicity Trial of Egg- Versus Non-Egg-Based Influenza Vaccines Among HCP
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT03722589 ↗Enrolled (actual)
727
Serious AEs
—
Results posted
Jul 2024
Primary outcome: Primary: Microneutralization (MN) Assay Response to Cell-grown Influenza A/H3N2 - Seroconversion Rate (SCR) — 112; 48; 29 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Flublok (Biological); Flucelvax (Biological); Fluarix (Biological); Fluzone (Biological); Fluzone High-Dose (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Centers for Disease Control and Prevention
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Microneutralization (MN) Assay Response to Cell-grown Influenza A/H3N2 - Seroconversion Rate (SCR) |
103; 106; 102; 79 | — |
| PRIMARY Microneutralization (MN) Assay Response to Cell-grown Influenza A/H3N2 - Seroconversion Rate (SCR) |
103; 106; 102; 79 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03722589). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.