Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine, Fluarix/Influsplit Tetra® (2013/2014 Season), in Adults 18 Years of Age and Older

NCT01878812 | Completed Phase 3 Results

• 2 other identifiers: 2001882013-001094-25
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to assess, in adults 18 years of age and above, the immunogenicity and reactogenicity of the seasonal influenza vaccine, Fluarix/Influsplit Tetra containing the four influenza strains (two A strains and two B strains) for the 2013/2014 season.

Conditions

Influenza

Keywords

Immunogenicity; Influenza; Adults; Safety; Elderly

Outcome Measures

Primary Outcomes (5)

• Anti-HI Antibody Titers Against 4 Strains of Influenza Disease

  The strains assessed were: Flu A/Christchurch/16/2010 H1N1 HI, Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata) ,Flu B/Brisbane/60/2008 Victoria HI. Titers are presented as geometric mean titers (GMTs).

  At Days 0 and 21

• Number of Seroprotected Subjects Against 4 Strains of Influenza Disease

  The strains are: Flu A/Christchurch/16/2010 H1N1 HI, Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI,(referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. A seroprotected subject is defined as a subject with serum HI titre ≥ 1:40.

  At Day 21

• Number of Seroconverted Subjects Against 4 Strains of Influenza Disease

  The strains are: Flu A/Christchurch/16/2010 H1N1 HI,(referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. A seroconverted subject is defined as a subject with either a pre-vaccination titer \< 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least 4-fold increase in post-vaccination titer.

  At Day 21

• Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Disease

  The strains are: Flu A/Christchurch/16/2010 H1N1 HI, (referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata) Flu B/Brisbane/60/2008 Victoria HI. MGI was defined as the fold increase in serum HI geometric mean titers post-vaccination compared to Day 0.

  At Day 21

• Seroprotection Powers (SPP) for HI Antibody Titer Against the 4 Flu Strains of Influenza Disease

  The strains are: Flu A/Christchurch/16/2010 H1N1 HI, (referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. SPP is defined as the percentage of subjects who had a pre-vaccination titer \< 1:40 and a post-vaccination titer ≥ 1:40.

  During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days)

Secondary Outcomes (10)

• Number of Subjects With Solicited Local Symptoms

  During a 21-day follow-up period after vaccination (i.e. day of vaccination and 20 subsequent days)

• Number of Days of Solicited Local Symptoms

  During the entire study period (Days 0 to 21)

• Number of Subjects With Solicited General Symptoms

  During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days)

• Number of Days of Solicited General Symptoms

  During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days)

• Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).

  During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days)

Study Arms (2)

Fluarix/Influsplit Tetra® Adult Group

EXPERIMENTAL

Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.

Biological: Fluarix/Influsplit Tetra® (2013-2014 season)

Fluarix/Influsplit Tetra® Elderly Group

EXPERIMENTAL

Subjects \>60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.

Biological: Fluarix/Influsplit Tetra® (2013-2014 season)

Interventions

Fluarix/Influsplit Tetra® (2013-2014 season) BIOLOGICAL

1 dose administered intramuscularly in the deltoid region of non-dominant arm

Fluarix/Influsplit Tetra® Adult Group; Fluarix/Influsplit Tetra® Elderly Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who the investigator believes can and will comply with the requirements of the protocol.
• A male or female aged 18 years or above at the time of vaccination.
• Written informed consent obtained from the subject.
• Healthy subjects or subjects with well-controlled chronic diseases as established by medical history and clinical examination before entering the study.
• Female subjects of non-childbearing potential may be enrolled in the study.
• Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
• Female subjects of childbearing potential may be enrolled in the study, if the subject:
• has practiced adequate contraception for 30 days prior to vaccination, and
• has a negative pregnancy test on the day of vaccination, and
• has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of vaccination.

You may not qualify if:

• Participation in previous year's Fluarix registration study (116663).
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
• Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within the six months prior to vaccination. Inhaled and topical steroids are allowed.
• Any administration of a long-acting immune-modifying drug within 6 months before study start, or planned administration during the study period.
• Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned administration during the study period.
• Administration of an influenza vaccine within the twelve months preceding the study vaccination.
• Receipt of a vaccine other than the study vaccine within 30 days before study vaccination and/or plan to receive any vaccine other than the study vaccine during the entire study period.
• Clinically or virologically confirmed influenza infection within the six months preceding the study vaccination.
• Acute disease and/or fever at the time of enrollment.
• Fever is defined as temperature ≥ 37.5°C/99.5°F on oral, axillary or tympanic setting, or ≥ 38.0°C/100.4°F on rectal setting. The preferred route for recording temperature in this study will be axillary.
• Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
• Acute, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
• Chronic underlying disease (such as cancer, chronic obstructive pulmonary disease under oxygen therapy, insulin-dependent diabetes mellitus), not stabilized or clinically serious.
• History of chronic alcohol consumption and/or drug abuse.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (4)

GSK Investigational Site

Dresden, Saxony, 01097, Germany

Location

GSK Investigational Site

Dresden, Saxony, 01099, Germany

Location

GSK Investigational Site

Dresden, Saxony, 01129, Germany

Location

GSK Investigational Site

Dresden, Saxony, 01309, Germany

Location

Related Links

• IPD for this study will be made available via the Clinical Study Data Request site.

MeSH Terms

Conditions

Influenza, Human

Interventions

fluarix

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2013
• First Posted: June 17, 2013
• Study Start: July 11, 2013
• Primary Completion: August 5, 2013
• Study Completion: August 5, 2013
• Last Updated: September 7, 2018
• Results First Posted: January 12, 2015

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

DE (4)