Phase 3
Completed N=1,350
Safety and Immunogenicity of Flublok Quadrivalent vs IIV4 in Adults 18-49 Years of Age
Source: ClinicalTrials.gov NCT02290509 ↗Enrolled (actual)
1,350
Serious AEs
0.9%
Results posted
Sep 2016
Primary outcomePrimary: Seroconversion to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine — 66.7; 63.5; 72.1; 57.0 percentage of participants
◆ Published Evidence
Established
56citations · ~6 / year
Randomized Comparison of Immunogenicity and Safety of Quadrivalent Recombinant Versus Inactivated Influenza Vaccine in Healthy Adults 18-49 Years of Age.
Summary
Randomized, double-blind trial of safety and immunogenicity of Flublok Quadrivalent versus Inactivated Influenza Vaccine (IIV4) in 1350 healthy, medically stable adults 18-49 years of age. Serum samples for Hemagglutinin Inhibition titers will be determined pre- and 28 days post-vaccination. Subjects will be followed for 6 months after vaccination for serious and/or medically-attended adverse events.
Linked Publications
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Randomized Comparison of Immunogenicity and Safety of Quadrivalent Recombinant Versus Inactivated Influenza Vaccine in Healthy Adults 18-49 Years of Age.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Seroconversion to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine |
66.7; 63.5; 72.1; 57.0; 59.6; 60.4 | — |
| PRIMARY Geometric Mean Titers of Antibodies to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine |
60; 54; 502; 407; 75; 70 | — |
| SECONDARY Number of Participants With Systemic and Injection Site Reactogenicity |
510; 172; 339; 119 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs) and Medically-attended Adverse Events (MAEs) |
10; 2; 80; 24 | — |
Eligibility Criteria
Inclusion Criteria
- Ambulatory, in good health or medically stable
- Able to understand and comply with planned study procedures
- Provide written informed consent
- Negative urine pregnancy test within 24 hours prior to vaccination (women of child-bearing potential)
Exclusion Criteria
- Prior serious or severe reaction to influenza vaccine
- Known contraindication to either study vaccine
- Receipt of any other influenza vaccine within 180 days prior to enrollment
- Plan to receive another licensed influenza or other vaccine during the duration of this study
- Receipt of any significant new diagnosis, medication (licensed or investigational), or licensed vaccine within 30 days prior to enrollment in this study
- Underlying disease or therapeutic intervention that might adversely affect the immune response
- Plans to participate in any investigation involving an investigational product during this study.
- Pregnant, lactating or planning to become pregnant within 30 days of study vaccine.
- Any clinical or social circumstance that in the opinion of the investigator could interfere with compliance with study procedures or interfere with the interpretation
Data sourced from ClinicalTrials.gov (NCT02290509) 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.