Inactivated Split Virus Seasonal Influenza Vaccine (Vero Cell-Derived)

Influenza Clinical Trial

Official title:

Randomized, Age-stratified, Double Blind, Controlled Phase 3 Study Comparing a Vero Cell-derived Trivalent Seasonal Influenza Vaccine Made by the Modified Manufacturing Process With Vaccine Made by the Current Manufacturing Process and a Licensed Trivalent Influenza Vaccine in Healthy Adults Aged 18 Years and Older

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01773928
• Other study ID #: 721104
• Status: Completed
• Phase: Phase 3
• First received: January 17, 2013
• Last updated: June 27, 2014
• Start date: January 2013
• Est. completion date: April 2013

Study information

• Verified date: June 2014
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if a Vero cell-derived trivalent seasonal influenza vaccine produced by the modified manufacturing process:

1. induces immune responses comparable to that produced by the current manufacturing process

2. has an acceptable safety profile compared to a licensed trivalent seasonal influenza vaccine

3. demonstrates consistency of immune response among three different lots.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1928
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participant is 18 to 49 years of age, inclusive, at the time of screening (for Cohort 18 to 49 years of age);

• Participant is 50 years of age, inclusive, or older at the time of screening (for Cohort 50 years of age or older);

• Participant gave written informed consent prior to study entry

• Participant is generally healthy without any significant medical risk conditions, as determined by the Investigator's clinical judgment through collection of medical history and performance of a physical examination;

• Participant is willing and able to comply with the requirements of the protocol;

• Participant agrees to keep a record of symptoms for the duration of the study;

• If female and capable of bearing children - participant has a negative urine pregnancy test at the study site, within 36 hours prior to vaccination, and agrees to employ adequate birth control measures for the duration of the study. For the purposes of this study adequate birth control measures incorporate one of the following FDA approved birth control measures for the duration of the study:

• Hormonal types of birth control (such as implants, birth control pills, patches or other methods) or an intrauterine device, OR

• A barrier type of birth control measure (i.e., condoms, diaphragms, cervical caps, etc.).

Exclusion Criteria:

• Participant has been vaccinated with seasonal trivalent influenza vaccine in the current season;

• Participant has an oral temperature of =100.4°F (=38.0°C) on the day of vaccination in this study;

• Participant has received a live vaccine within 4 weeks, or an inactivated or subunit vaccine within 2 weeks of study entry;

• Participant with a known history of infection with Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBsAgs) or Hepatitis C Virus (HCV);

• Participant has any medically diagnosed or suspected immune deficient condition based on medical history and physical examination as determined by the Investigator;

• Participant has an immune compromising condition or disease, or is currently undergoing a form of treatment or was undergoing a form of treatment within 30 days prior to study entry that can be expected to influence immune response. Such treatment includes, but is not limited to, systemic or high dose inhaled corticosteroids (> 800 µg/day of beclomethasone dipropionate or equivalent), radiation treatment or other immunosuppressive or cytotoxic drugs (use of inhaled and nasal steroids will be permitted);

• Participant has a known history of Guillain Barré Syndrome, demyelinating disorders (including acute demyelinating encephalomyelitis (ADEM), Multiple Sclerosis) or convulsions;

• Participant has a history of severe allergic reactions or anaphylaxis as determined by the Investigator;

• Participant has a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating as determined by the Investigator;

• Participant has received any blood products (e.g. blood transfusion or immunoglobulins) within 90 days prior to study entry;

• Participant has donated one or more units of blood (approximately 450 mL) or plasma within 30 days prior to study entry;

• Participant has a functional or surgical asplenia;

• Participant has a known or suspected problem with alcohol or drug abuse as determined by the Investigator;

• Participant is a member of the team conducting this study or is in a dependent relationship with one of the study team members. Dependent relationships include close relatives (ie., children, partner/spouse, siblings, parents) as well as employees of the Investigator or study site personnel conducting the study;

• If female, participant is pregnant or lactating at the time of study enrollment;

• Participant is currently enrolled or has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to study enrolment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study;

• Participant has any condition that in the opinion of the Investigator would interfere with evaluation of the vaccine or interpretation of study results.

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)

• VCIV manufactured with the current manufacturing process (VCIV current)

• Fluzone®, licensed trivalent influenza vaccine (TIV)

Locations

Country	Name	City	State
United States	Anaheim Clinical Trials	Anaheim	California
United States	Benchmark Research Austin	Austin	Texas
United States	PMG Research of Cary, LLC	Cary	North Carolina
United States	East Valley Family Physicians, PLC	Chandler	Arizona
United States	Rapid Medical Research, Inc.	Cleveland	Ohio
United States	Clinical Research of South Florida	Coral Gables	Florida
United States	Avail Clinical Research, LLC	Deland	Florida
United States	Benchmark Research	Fort Worth	Texas
United States	The Center for Pharmaceutical Research, P.C.	Kansas City	Missouri
United States	Center for Clinical Trials, LLC	Paramount	California
United States	Wake Research Associates, LLC	Raleigh	North Carolina
United States	Rochester Clinical Research Inc.	Rochester	New York
United States	Jean Brown Research	Salt Lake City	Utah
United States	California Research Foundation	San Diego	California
United States	Benchmark Research San Francisco	San Francisco	California
United States	Miami Research Associates	South Miami	Florida
United States	Spartanburg Medical Research	Spartanburg	South Carolina
United States	Sundance Clinical Research, LLC	St. Louis	Missouri
United States	Clinical Research Atlanta	Stockbridge	Georgia
United States	Heartland Research Associates, LLC	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation

Country where clinical trial is conducted

United States, 

References & Publications (1)

StatXact 7 PROCs for SAS Users, Cytel Inc, Cambridge, 2005.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemagglutination inhibition antibody (HIA) titer for each of the three antigens contained in the vaccine		21 days post-vaccination
Primary	Number of participants with fever		onset within 7 days post vaccination
Secondary	Number of participants with seroprotective antibody titer [reciprocal HIA titer =40] for each of the three antigens contained in the vaccine		21 days post-vaccination
Secondary	Number of participants demonstrating seroconversion to each of the three antigens contained in the vaccine	Seroconversion is defined as a = 4-fold increase in HIA titer from baseline OR a reciprocal HIA titer = 40 when there is no detectable HIA titer (reciprocal HIA titer < 10) at baseline	21 days post-vaccination
Secondary	Fold increase of HIA titer for each of the three antigens contained in the vaccine as compared to baseline		21 days post-vaccination
Secondary	Number of participants with solicited systemic reactions		within 7 days post-vaccination
Secondary	Number of participants with injection site reactions		within 7 days post-vaccination
Secondary	Frequency and severity of each solicited systemic reaction and injection site reaction		within 7 days of vaccination
Secondary	Number of participants with adverse events		within 21 days post-vaccination
Secondary	Frequency and severity of adverse events		within 21 days post-vaccination