drugset / Trial / NCT00539981
Immunogenicity, Safety, Reactogenicity, Efficacy, Effectiveness and Lot Consistency of FluBlok
RandomizedParallel-groupTriple-blindPrevention
Summary
The purpose of this study was to evaluate a single dose of FluBlok in terms of safety, efficacy and effectiveness in prevention of influenza and influenza-like illness and assess clinical lot-to-lot consistency in manufacturing by evaluating and comparing the immunogenicity of three different lots of FluBlok in a subset of participants.
Timeline
- Start
- 2007-09-15
- Primary completion
- 2008-05-28
- Completion
- 2008-05-28
Outcome
Missed primary endpoint
registry FluBlok: Lot A vs FluBlok: Lot B; p = 0.065; GMT ratio 2.03 (95% CI 1.56 to 2.64); ANOVA NCT00539981 ↗
registry Relative protective efficacy 75.4 (95% CI -148.0 to 99.5) NCT00539981 ↗
Publications
- Background Treanor JJ, El Sahly H, King J, Graham I, Izikson R, Kohberger R, Patriarca P, Cox M. Protective efficacy of a trivalent recombinant hemagglutinin protein vaccine (FluBlok(R)) against influenza in healthy adults: a randomized, placebo-controlled trial. Vaccine. 2011 Oct 13;29(44):7733-9. doi: 10.1016/j.vaccine.2011.07.128. Epub 2011 Aug 9.
- Rajendran M, Nachbagauer R, Ermler ME, Bunduc P, Amanat F, Izikson R, Cox M, Palese P, Eichelberger M, Krammer F. Analysis of Anti-Influenza Virus Neuraminidase Antibodies in Children, Adults, and the Elderly by ELISA and Enzyme Inhibition: Evidence for Original Antigenic Sin. mBio. 2017 Mar 21;8(2):e02281-16. doi: 10.1128/mBio.02281-16.
- Nachbagauer R, Choi A, Izikson R, Cox MM, Palese P, Krammer F. Age Dependence and Isotype Specificity of Influenza Virus Hemagglutinin Stalk-Reactive Antibodies in Humans. mBio. 2016 Jan 19;7(1):e01996-15. doi: 10.1128/mBio.01996-15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Flublok | Vaccine | 0.5 ml | Intramuscular |