Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Trivalent Split Virion Influenza Vaccine Fluviral™ (2013-2014 Season) in Adults Aged 18 Years and Older

NCT01878825 | Completed Phase 3 Results

• 1 other identifier: 200190
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the immunogenicity, reactogenicity and safety of Fluviral™ containing the influenza strains recommended for the 2013-2014 season in adults aged 18 years and older.

Conditions

Influenza

Keywords

Immunogenicity; Trivalent; Safety; Adults; Elderly; Influenza

Outcome Measures

Primary Outcomes (4)

• Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Influenza Strains

  Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).

  At Days 0 and 21

• Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Influenza Strains.

  A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).

  At Day 21

• Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains.

  MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).

  At Day 21

• Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains.

  A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).

  At Days 0 and Day 21

Secondary Outcomes (8)

• Humoral Immune Response in Terms of HI Antibody Titers Against Each of the Three Vaccine Influenza Strains

  At Days 0 and Day 21

• Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Influenza Strains.

  At Day 21

• Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains.

  At Day 21

• Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains.

  At Day 0 and Day 21

• Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.

  During the 4-day (Days 0-3) post-vaccination period

Study Arms (2)

Fluviral 18-60 Years Group

EXPERIMENTAL

Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Biological: Fluviral™

Fluviral >60 Years Group

EXPERIMENTAL

Subjects aged \> 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm

Biological: Fluviral™

Interventions

Fluviral™ BIOLOGICAL

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

Fluviral 18-60 Years Group; Fluviral >60 Years 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, in the opinion of the investigator, can and will comply with the requirements of the protocol.
• A male or female 18 years of age and older at the time of the first vaccination.
• Written informed consent obtained from the subject.
• Healthy subjects or subjects with well-controlled chronic disease, as established by medical history and clinical examination before entering into 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 the vaccination dose.

You may not qualify if:

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine 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 six months prior to the vaccine dose. For corticosteroids, this will mean prednisone ≥ 20 mg/day, or equivalent. Inhaled and topical steroids are allowed.
• Any administration of a long-acting immune-modifying drug (e.g. rituximab, infliximab etc.) within 6 months before study start, or planned administration during the study period.
• Administration of any influenza vaccine within 6 months preceding the study start or planned use of such vaccines during the study period.
• Administration of any other vaccine(s) within 30 days prior to study enrollment or during the study period.
• Clinically or virologically confirmed influenza infection within the 6 months preceding the study vaccination.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required):
• History of human immunodeficiency virus (HIV) infection,
• Cancer or treatment for cancer, within 3 years of study enrollment. Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible.
• Acute disease and/or fever at the time of enrollment.
• Acute disease is defined as the presence of a short term, moderate or severe illness, with or without fever.
• Fever is defined as temperature ≥ 38.0°C/100.4°F for oral, axillary or tympanic route. The preferred route for recording temperature in this study will be oral.
• Subjects with a minor illness (such as mild diarrhea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
• Significant acute or chronic, uncontrolled medical or psychiatric or neurological illness. "Uncontrolled" is defined as:
• Requiring institution of new medical or surgical treatment within one month prior to study enrollment, or

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Sherbrooke, Quebec, J1H 1Z1, Canada

Location

Related Links

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

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

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 18, 2013
• Primary Completion: August 9, 2013
• Study Completion: August 9, 2013
• Last Updated: September 7, 2018
• Results First Posted: January 16, 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

CA (1)