Immunogenicity, Safety, Reactogenicity, Efficacy, Effectiveness and Lot Consistency of FluBlok

NCT00539981 | Completed Phase 3 Results FDA Drug

• 1 other identifier: PSC04
• Study Type: interventional
• Target: 4,648
• Locations: 1 country
• Sites: 24

Brief 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.

Conditions

Influenza

Keywords

Influenza

Outcome Measures

Primary Outcomes (5)

• Number of Participants Reporting Solicited Injection Site (Local) Reactions

  Solicited reaction (reactogenicity event) was an adverse event (AE) that was pre-listed in electronic case report form(eCRF), considered to be related to vaccination and recorded by participant by means of memory aid. Injection sites reaction included pain,bruising,redness,swelling. Pain and bruising:Grade0: didn't have it at all; Grade1: noticed it, but it didn't interfere with usual activities at all; Grade2: had it, and it was bad enough to prevent a significant part of usual activities; Grade3: had it, and it prevented most or all of normal activities, or had to see a doctor for prescription medicine, Redness and swelling: participants measured largest diameter of any injection site reaction and grade them from 0 to 3, where Grade0: measured less than(\<)10 milliliters(mm); Grade1: larger than or equal to(\>=) 10mm and \<20mm; Grade 2: \>=20mm and \<50mm; Grade3: \>=50mm. Participants with multiple symptoms in same category were counted once per category using symptom with maximum grade

  Within 7 days post vaccination

• Number of Participants Reporting Solicited Systemic Reactions

  Solicited reaction (reactogenicity event) was an AE that was pre-listed in eCRF, considered to be related to vaccination recorded by the participant by means of a memory aid between the day of vaccination (Day 0) and Day 7 post vaccination. Systemic events included fever, fatigue, shivering, joint pain, muscle pain, headache, and nausea. Fever: \>=100.4 degree Fahrenheit (ºF) to \<101.1ºF; \>=101.2ºF to \<102.2ºF; \>=102.2ºF; Fatigue, shivering, joint pain, muscle pain, headache and nausea: Grade 0: didn't have it at all; Grade 1: noticed it, but it didn't interfere with usual activities at all; Grade 2: had it, and it was bad enough to prevent a significant part of usual activities; and Grade 3: had it, and it prevented most or all of normal activities, or had to see a doctor for prescription medicine. Participants with multiple symptoms in the same category were counted once per category using the symptom with the maximum grade.

  Within 7 days post vaccination

• Number of Participants Reporting Unsolicited Adverse Events

  An AE was defined as any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a study vaccine, whether or not considered to be related to the study vaccine. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination, ascertained during follow-up visit or telephone contact up to (and including) the Day 28 contact, whether reported spontaneously by the participant or in response to general questions about current or interim health status.

  From Day 0 (post-vaccination) through Day 28 post vaccination

• Lot Consistency: Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies Following FluBlok Vaccination

  GMTs of anti-influenza antibodies were measured using a single radial immunodiffusion (SRID) assay for 3 strains: A/Solomon Islands \[H1N1\], A/Wisconsin \[H3N2\], and B/Malaysia. Titers were expressed in terms of 1/dilution.

  Day 28 post vaccination

• Percentage of Participants With Positive Cell Culture/Culture-Confirmed Influenza Like Illness as Defined by Centers for Disease Control and Prevention (CDC-ILI)

  CDC-defined ILI was defined as fever (body temperature \>=100ºF oral accompanied by cough and/or sore throat, on the same day or on consecutive days) due to strains represented in the vaccine.

  14 days post vaccination through and up to 6 months

Secondary Outcomes (2)

• Percentage of Participants With Seroprotection to Influenza Vaccine Antigens After Vaccination With FluBlok

  28 days post vaccination

• Percentage of Participants With Seroconversion to Influenza Vaccine Antigens After Vaccination With FluBlok

  28 days post vaccination

Study Arms (2)

FluBlok (Lots A, B, C)

EXPERIMENTAL

Participants received a single 0.5 milliliters (mL) dose of FluBlok vaccine from any of the Lots A, B, or C, intramuscularly on Day 0 (Visit 1). Participants were followed up to 6 months after vaccination.

Biological: FluBlok®

Placebo

PLACEBO COMPARATOR

Participants received a single dose of placebo matched to FluBlok, intramuscularly on Day 0 (Visit 1). Participants were followed up to 6 months after vaccination.

Biological: Placebo

Interventions

FluBlok® BIOLOGICAL

Dose: 0.5 mL, single dose; Route of administration: intramuscular. Recombinant Trivalent Hemagglutinin Influenza Vaccine containing 45 microgram (mcg) of each hemagglutinin derived from A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004

Also known as: rHA Trivalent Recombinant Hemagglutinin Influenza Vaccine

FluBlok (Lots A, B, C)

Placebo BIOLOGICAL

Dose: 0.5 mL normal saline for injection, single dose; Route of administration: intramuscular

Placebo

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult aged 18-49 years.
• Provided informed consent prior to any study procedures.
• Able to comply with all study procedures.
• Available for follow-up for the duration of the influenza season.
• Women of child-bearing potential must have had a negative urine pregnancy test at the time of randomization and must be willing to use an adequate form of contraception (includes abstinence, condom with spermicide, licensed hormonal contraceptive, intrauterine device \[IUD\], monogamous relationship with a vasectomized partner) during the course of the study.

You may not qualify if:

• Long-term use of oral steroids, parenteral steroids, or high-dose inhaled steroids (greater than \[\>\] 800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (Nasal and topical steroids were allowed).
• Presence of high-risk conditions or other characteristics were considered to be indication for influenza vaccination, as defined by the Advisory Committee on Immunization Practices.
• Acute febrile illness (defined as having a temperature greater than or equal to \[\>=\]100 degrees Fahrenheit) or upper respiratory tract illness within 72 hours of vaccination. Participants with acute febrile illness were rescheduled after fever resolved.
• Use of experimental vaccines or any influenza vaccine other than FluBlOk after May 31st 2007 for the 2008 Southern Hemisphere or 2007 to 2008 Northern hemisphere epidemic seasons.
• Immunosuppression as a result of an underlying illness or treatment, or used anticancer chemotherapy or radiation therapy within the preceding 36 months.
• Any malignancy diagnosed or treated actively during the past five (5) years, with two (2) exceptions. Participant with any history of lymphoproliferative disorder were excluded. However, participants with a history of localized non-melanotic skin cancer were eligible.
• Receipt of any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study.
• Receipt of an experimental agent (vaccine, drug, biologic, device, blood product or medication) within 1 month prior to enrollment in this study, or expected to receive an experimental agent during study period.
• Receipt of parenteral immunoglobulin or other blood product within the three months prior to study vaccination.
• Major psychiatric diagnosis including schizophrenia, bipolar disease or other major depression, or any diagnosis of dementia or associated concomitant medications (e.g., Aricept) used for treating dementia.
• Known active human immunodeficiency virus, hepatitis B, or hepatitis C infection.
• History of alcohol or drug abuse in the last 5 years.
• Not available for three or more consecutive weeks during flu surveillance period.
• Any acute or chronic condition that, in the opinion of the investigator, would render vaccination unsafe or interfere with the evaluation of responses or render the participant unable to meet the requirements of the protocol.

Sponsors & Collaborators

• Sanofi: lead
• Protein Sciences Corporation: collaborator

Study Sites (24)

Impact Clinical Trials

Beverly Hills, California, 90211, United States

Location

Benchmark Research - Sacramento

Sacramento, California, 95816, United States

Location

Benchmark Research - San Francisco

San Francisco, California, 94102, United States

Location

University Clinical Research, Inc

Pembroke Pines, Florida, 33024, United States

Location

Vince and Associates

Overland Park, Kansas, 66212, United States

Location

Kentucky pediatric /Adult Research

Bardstown, Kentucky, 40004, United States

Location

Benchmarch Research - New Orleans

Metairie, Louisiana, 70006, United States

Location

University of Maryland - Baltimore

Baltimore, Maryland, 21201, United States

Location

Saint Louis University

St Louis, Missouri, 63110, United States

Location

Meridian Clinical Research

Omaha, Nebraska, 68134, United States

Location

Regional Clinical Research, Inc.

Endwell, New York, 13760, United States

Location

Rochester Medical Center

Rochester, New York, 14642, United States

Location

Carolina Medical Trials

Winston-Salem, North Carolina, 27103, United States

Location

Sterling Research

Cincinnati, Ohio, 45246, United States

Location

Primary Physicians Research - Pediatric Alliance St. Clair

Pittsburgh, Pennsylvania, 15241, United States

Location

Primary Physicians Research

Pittsburgh, Pennsylvania, 15241, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Benchmarch Research - Austin

Austin, Texas, 78705, United States

Location

Benchmark Research - Fort Worth

Fort Worth, Texas, 76135, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Benchmark Research - San Angelo

San Angelo, Texas, 76904, United States

Location

Jean Brown Research

Salt Lake City, Utah, 84124, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

Marshfield Clinic

Marshfield, Wisconsin, 54449, United States

Location

Related Publications (3)

• 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.

  PMID: 21835220 BACKGROUND

• 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.

  PMID: 28325769 DERIVED

• 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.

  PMID: 26787832 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Influenza, Human

Interventions

FluBlok

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi Pasteur

Contact-US@sanofi.com

800-633-1610

Study Officials

• John J Treanor, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2007
• First Posted: October 5, 2007
• Study Start: September 15, 2007
• Primary Completion: May 28, 2008
• Study Completion: May 28, 2008
• Last Updated: April 6, 2022
• Results First Posted: February 15, 2021

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share

Locations

US (24)