Phase 4
Completed N=727
Immunogenicity Trial of Egg- Versus Non-Egg-Based Influenza Vaccines Among HCP
Source: ClinicalTrials.gov NCT03722589 ↗Enrolled (actual)
727
Serious AEs
—
Results posted
Jul 2024
Primary outcomePrimary: Microneutralization (MN) Assay Response to Cell-grown Influenza A/H3N2 - Seroconversion Rate (SCR) — 112; 48; 29 Participants
◆ Published Evidence
Established
45citations · ~9 / year
Comparison of the Immunogenicity of Cell Culture-Based and Recombinant Quadrivalent Influenza Vaccines to Conventional Egg-Based Quadrivalent Influenza Vaccines Among Healthcare Personnel Aged 18-64 Years: A Randomized Open-Label Trial.
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.
Linked Publications (3)
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Comparison of the Immunogenicity of Cell Culture-Based and Recombinant Quadrivalent Influenza Vaccines to Conventional Egg-Based Quadrivalent Influenza Vaccines Among Healthcare Personnel Aged 18-64 Years: A Randomized Open-Label Trial.
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Redirecting antibody responses from egg-adapted epitopes following repeat vaccination with recombinant or cell culture-based versus egg-based influenza vaccines.
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Effect of Repeat Vaccination on Immunogenicity of Quadrivalent Cell-Culture and Recombinant Influenza Vaccines Among Healthcare Personnel Aged 18-64 Years: A Randomized, Open-Label Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Microneutralization (MN) Assay Response to Cell-grown Influenza A/H3N2 - Seroconversion Rate (SCR) |
103; 106; 102; 79 | — |
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) and the linked publication. 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. Informational only — not medical advice.