Comparison of the Safety of Flublok® Versus Licensed IIV in Healthy, Medically Stable Adults ≥ 50 Years of Age

Influenza Clinical Trial

Official title:

Comparison of the Safety of Flublok® Versus Licensed Inactivated Influenza Vaccine in Healthy, Medically Stable Adults ≥ 50 Years of Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01825200
• Other study ID #: PSC11
• 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

• Influenza
• Influenza, Human

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

External Links

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