Phase 3
Completed N=8,963
Protective Efficacy of Flublok® Quadrivalent Versus Licensed Inactivated Influenza Vaccine in Adults ≥50 Years of Age
Source: ClinicalTrials.gov NCT02285998 ↗Enrolled (actual)
8,963
Serious AEs
3.2%
Results posted
Oct 2016
Primary outcomePrimary: Number of Participants With rtPCR-confirmed Influenza-Like Illness — 96; 138 participants
◆ Published Evidence
Highly cited
284citations · ~32 / year
Efficacy of Recombinant Influenza Vaccine in Adults 50 Years of Age or Older.
Summary
The goal of this study is to establish that Flublok Quadrivalent is non-inferior to fully licensed (traditional approval status) quadrivalent inactivated influenza vaccine (IIV4) in protecting against laboratory-confirmed clinical influenza disease in the ≥50 year age population.
Linked Publications
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Efficacy of Recombinant Influenza Vaccine in Adults 50 Years of Age or Older.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With rtPCR-confirmed Influenza-Like Illness |
96; 138 | — |
| SECONDARY Number of Participants With Culture-confirmed Influenza-Like Illness |
58; 101 | — |
| SECONDARY Number of Participants With Culture-confirmed CDC-defined Influenza-Like Illness |
38; 64 | — |
| SECONDARY Number of Participants With rtPCR-confirmed CDC-defined Influenza-Like Illness |
54; 83 | — |
| SECONDARY Percentage of Participants With Seroconversion |
44.9; 49.0; 54.5; 43.3; 38.9; 38.3 | — |
| SECONDARY Number of Participants With Local Injection Site Reactogenicity |
1621; 1745 | — |
| SECONDARY Number of Participants With Unsolicited Adverse Events |
1345; 1355 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs) and Medically-attended Adverse Events (MAEs) |
145; 132; 774; 785 | — |
| SECONDARY Measure of Post-vaccination HAI GMTs |
45; 49; 194; 224; 88; 100 | — |
| SECONDARY Number of Participants With Systemic Reactogenicity |
1077; 1106 | — |
Eligibility Criteria
Inclusion Criteria
- Ambulatory adults aged 50 and older.
- Medically stable, as determined by medical history and targeted physical examination. "Medically stable" is defined as no change in diagnoses or chronic medications (dose or class) for medical reasons in the 3 months prior to study.
- Absence of underlying conditions that make participation in the study contrary to the subject's best interest.
- Able to understand and comply with planned study procedures.
- Provides written informed consent prior to initiation of any study procedure.
Exclusion Criteria
- Known contraindication to either study vaccine (see product package inserts)
- Receipt of any other influenza vaccine within 180 days prior to enrollment in this study.
- Underlying disease or ongoing therapy that might cause immunocompromise, e.g. cytotoxic agents or supraphysiologic doses of corticosteroids, such that response to vaccination might be sub-optimal.
Data sourced from ClinicalTrials.gov (NCT02285998) 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.