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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01825200
Other study ID # PSC11
Secondary ID
Status Completed
Phase Phase 3
First received March 11, 2013
Last updated January 29, 2015
Start date March 2013
Est. completion date May 2013

Study information

Verified date January 2015
Source Protein Sciences Corporation
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Description:

The Advisory Committee on Immunization Practices (ACIP) recommends that all people aged 6 months and older be immunized to prevent influenza. Currently the only approved influenza vaccine across the entire age group is inactivated influenza vaccine (IIV). A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Additional safety and, ultimately efficacy, data is needed to support use in adults ≥50 years of age, an important age group as adults ≥65 years of age are among those at increased risk of influenza complications.


Recruitment information / eligibility

Status Completed
Enrollment 2640
Est. completion date May 2013
Est. primary completion date May 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 50 Years and older
Eligibility Inclusion Criteria:

1. Ambulatory adults aged 50 years and older

2. Medically stable, as determined by medical history and targeted physical examination based on medical history, if appropriate

3. Able to understand and comply with planned study procedures

4. Provides written informed consent prior to initiation of any study procedure.

Exclusion Criteria:

1. Known contraindication to either study vaccine (see product package inserts)

2. Receipt of any other influenza or other vaccine within 30 days prior to enrollment in this study.

3. Receipt of any new medication within 30 days prior to enrollment in this study

4. Plans to participate in any investigation involving an investigational product during this study.

5. Pre-existence of atopic dermatitis or any other cutaneous disorder that could complicate the evaluation of potential primary endpoints.

6. 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Biological:
Flublok
A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions.
Afluria
Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs.

Locations

Country Name City State
United States Maine Research Associates, LLC Auburn Maine
United States Regional Clinical Research Binghamton New York
United States Rapid Medical Research, Inc. Cleveland Ohio
United States Clinical Research of South Florida Coral Gables Florida
United States Research Across America Dallas Texas
United States Benchmark Research Fort Worth Texas
United States Clinical Research Center of Nevada, LLC Las Vegas Nevada
United States Benchmark Research Metairie Louisiana
United States Meridian Clinical Research Omaha Nebraska
United States Wake Research Raleigh North Carolina
United States Benchmark Research San Angelo Texas
United States Meridian Clinical Research Savannah Georgia
United States Genova Clinical Research Tucson Arizona
United States Heartland Research Associates, LLC Wichita Kansas

Sponsors (1)

Lead Sponsor Collaborator
Protein Sciences Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Common Hypersensitivity Reactions as Measure of Safety Number of participants who experience a pre-defined common systemic hypersensitivity adverse event, including rash, urticaria, swelling or edema through Day 30 post-vaccine administration. 30 Days Yes
Secondary Subjects With at Least One Unsolicited Adverse Event in the 30 Days Following Vaccine Administration Subjects with at least one serious adverse event and subjects with at least one medically-attended unsolicited adverse event occurring during the 30 days following vaccine administration 30 Days Yes
Secondary Number of Participants With Local and Systemic Events Reported as a Measure of Safety Number of solicited local and systemic events of reactogenicity reported with the help of a memory aid during the seven days following vaccine administration. 7 Days Yes
Secondary Subjects With at Least One Hypersensitivity Event Reported on Day 0 and Days 0-7 Following Vaccine Administration as a Measure of Safety Subjects with at least one pre-defined common systemic hypersensitivity adverse event, including rash, urticaria, swelling or non-dependent edema on Day 0 and for Days 0 to 7 following vaccine administration 7 Days Yes
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