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| Sponsor: | Protein Sciences Corporation |
|---|---|
| Information provided by: | Protein Sciences Corporation |
| ClinicalTrials.gov Identifier: | NCT00539981 |
Purpose
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 subjects.
| Condition | Intervention | Phase |
|---|---|---|
|
Influenza |
Biological: Influenza Vaccine, recombinant hemagglutinin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Evaluation of the Immunogenicity, Safety, Reactogenicity, Efficacy, Effectiveness and Lot Consistency of FluBlok® Trivalent Recombinant Baculovirus-Expressed Hemagglutinin Influenza Vaccine In Healthy Adults Aged 18 to 49 |
| Enrollment: | 4648 |
| Study Start Date: | September 2007 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
FluBlok: Experimental
Recombinant Trivalent Hemagglutinin Influenza Vaccine, 2007/08 formulation containing 45μg of each hemagglutinin derived from A/Solomon Islands/3/2006(H1N1), A/Wisconsin/67/2005(H3N2), and B/Malaysia/2506/2004
|
Biological: Influenza Vaccine, recombinant hemagglutinin
0.5mL dose for IM injection
|
|
Placebo: Placebo Comparator
0.9% Sodium Chloride
|
Biological: Influenza Vaccine, recombinant hemagglutinin
0.5mL dose for IM injection
|
All currently licensed influenza vaccines in the United States are produced in embryonated hen's eggs. There are several well-recognized disadvantages to the use of eggs as the substrate for influenza vaccine. Eggs require specialized manufacturing facilities and could be difficult to scale up rapidly in response to an emerging need such as a pandemic. It is usually necessary to adapt candidate vaccine viruses for high-yield growth in eggs, a process that can be time consuming, is not always successful, and can select receptor variants that may have suboptimal immunogenicity. In addition, agricultural diseases that affect chicken flocks, and that might be an important issue in a pandemic due to an avian influenza virus strain, could easily disrupt the supply of eggs for vaccine manufacturing. Therefore, development of alternative substrates for influenza vaccine production has been identified as a high-priority objective.
One potential alternative method for production of influenza vaccine is expression of the influenza virus hemagglutinin (HA) using recombinant DNA techniques. This alternative avoids dependence on eggs and is very efficient because of the high levels of protein expression under the control of the baculovirus polyhedrin promoter.
Eligibility| Ages Eligible for Study: | 18 Years to 49 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 24 Study Locations| Principal Investigator: | John J Treanor, MD | University of Rochester |
More Information
| Responsible Party: | Protein Sciences Corporation ( Manon Cox ) |
| Study ID Numbers: | PSC04 |
| Study First Received: | October 3, 2007 |
| Last Updated: | January 8, 2010 |
| ClinicalTrials.gov Identifier: | NCT00539981 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Influenza |
|
Virus Diseases RNA Virus Infections Immunologic Factors Respiratory Tract Diseases Respiratory Tract Infections Hemagglutinins |
Physiological Effects of Drugs Agglutinins Influenza, Human Orthomyxoviridae Infections Pharmacologic Actions |