Phase 3
Completed N=2,640
Comparison of the Safety of Flublok® Versus Licensed IIV in Healthy, Medically Stable Adults ≥ 50 Years of Age
Source: ClinicalTrials.gov NCT01825200 ↗Enrolled (actual)
2,640
Serious AEs
0.6%
Results posted
Feb 2015
Primary outcomePrimary: Number of Participants With Common Hypersensitivity Reactions as Measure of Safety — 31; 21 participants
Summary
The hypothesis for this trial is that the incidence of a pre-defined composite of common systemic hypersensitivity adverse events for Flublok recipients is non-inferior to that reported for licensed IIV recipients. Another hypothesis is that the safety and reactogenicity of Flublok is clinically acceptable, i.e. consistent with the overall safety profiles previously observed with Flublok and with the licensed comparator.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Common Hypersensitivity Reactions as Measure of Safety |
31; 21 | — |
| SECONDARY Subjects With at Least One Unsolicited Adverse Event in the 30 Days Following Vaccine Administration |
5; 10; 53; 51 | — |
| SECONDARY Number of Participants With Local and Systemic Events Reported as a Measure of Safety |
432; 480 | — |
| SECONDARY Subjects With at Least One Hypersensitivity Event Reported on Day 0 and Days 0-7 Following Vaccine Administration as a Measure of Safety |
5; 3; 25; 12 | — |
Eligibility Criteria
Inclusion Criteria
- Ambulatory adults aged 50 years and older
- Medically stable, as determined by medical history and targeted physical examination based on medical history, if appropriate
- 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 or other vaccine within 30 days prior to enrollment in this study.
- Receipt of any new medication within 30 days prior to enrollment in this study
- Plans to participate in any investigation involving an investigational product during this study.
- Pre-existence of atopic dermatitis or any other cutaneous disorder that could complicate the evaluation of potential primary endpoints.
- Any clinical or social circumstance that in the opinion of the investigator could interfere with compliance with study procedures or interfere with the interpretation of clinical data.
Data sourced from ClinicalTrials.gov (NCT01825200). 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.