Immunogenicity & Safety Study of Fluviral® (2009 - 2010 Season) in Adults Aged 18 to 60 Years and Over 60 Years

NCT00929331 | Completed Phase 3 Results

• 1 other identifier: 110586
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to test the safety and immunogenicity of Fluviral® (2009 - 2010 Season) in adults aged 18 to 60 years and over 60 years.

Conditions

Influenza, Human

Keywords

Influenza; Fluviral®

Outcome Measures

Primary Outcomes (7)

• Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies

  Data are displayed as GMTs for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.

  At Day 0

• GMTs of HI Antibodies

  Data are displayed as GMTs for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.

  At Day 21 after vaccination

• Number of Subjects With a Serum HI Titer Equal to or Above the Cut-off Value

  The cut-off value was defined as a serum HI titer \>= 1:40, which is usually accepted as indicating protection. Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.

  At Day 0

• Number of Subjects With a Serum HI Titer Equal to or Above the Cut-off Value

  The cut-off value was defined as a serum HI titer \>= 1:40, which is usually accepted as indicating protection. Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.

  At Day 21 after vaccination

• Number of Seroconverted Subjects

  A seroconverted subject is a subject who had either a prevaccination titer \< 1:10 and a post-vaccination titer \>= 1:40 or a pre-vaccination titer \>= 1:10 and at least a four-fold increase in post-vaccination titer. Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.

  At Day 21 after vaccination

• Seroconversion Factors

  Seroconversion factors are defined as the fold increase in serum HI GMTs post-vaccination (Day 21) compared to pre-vaccination (Day 0). Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.

  At Day 21 after vaccination

• Number of Subjects With a Pre-vaccination Titer Below the Cut-off Value and a Post-vaccination Titer Equal to or Above the Cut-off Value

  The cut-off value was a titer of 1:40. Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.

  At Day 21 after vaccination

Secondary Outcomes (7)

• Number of Subjects Reporting Any Solicited Local Symptoms

  During a 4-day (Day 0-3) follow-up period after vaccination

• Number of Subjects Reporting Grade 3 Solicited Local Symptoms

  During a 4-day (Day 0-3) follow-up period after vaccination

• Number of Subjects Reporting Any Solicited General Symptoms

  During a 4-day (Day 0-3) follow-up period after vaccination

• Number of Subjects Reporting Grade 3 Solicited General Symptoms

  During a 4-day (Day 0-3) follow-up period after vaccination

• Number of Subjects Reporting Related Solicited General Symptoms

  During a 4-day (Day 0-3) follow-up period after vaccination

Study Arms (2)

Fluviral Adult Group

EXPERIMENTAL

Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm

Biological: Fluviral®

Fluviral Elderly Group

EXPERIMENTAL

Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm

Biological: Fluviral®

Interventions

Fluviral® BIOLOGICAL

Intramuscular injection, one dose

Fluviral Adult Group; Fluviral 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 that they can and will comply with the requirements of the protocol.
• Written informed consent obtained from the subject
• Male and female adults, 18 to 60 years of age and over 60 years of age.
• Satisfactory baseline medical assessment by history and physical examination
• Comprehension of the study requirements, ability to comprehend and comply with procedures for collection of safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits.
• 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 series.

You may not qualify if:

• Participation in previous year's (2008) Fluviral® registration study
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s)/product(s) within 30 days preceding the first dose of study vaccine/product, or planned use during the study period.
• Acute disease at the time of enrollment. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e. oral temperature \<38.0°C.
• Significant acute or chronic, uncontrolled medical or psychiatric illness. "Uncontrolled" is defined as:
• Requiring institution of new medical or surgical treatment within one (1) month prior to study enrollment, or Requiring the re-institution of a previously discontinued medication or medical treatment within one month prior to study enrollment, or Requiring a change in medication dosage in the one month prior to study enrollment due to uncontrolled symptoms or drug toxicity (elective dosage adjustments in stable subjects are acceptable), or Hospitalization or an event fulfilling the definition of a SAE within one month prior to study enrollment.
• Any confirmed or suspected immunosuppressive condition including: 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.
• History of renal impairment.
• History of hepatic dysfunction due to hepatitis B, C or toxins including alcohol.
• Complicated insulin-dependent diabetes mellitus.
• Unstable cardiopulmonary disease requiring chronic medical therapy or associated with functional impairment.
• Presence of blood dyscrasias, including hemoglobinopathies and myelo- or lymphoproliferative disorder.
• Receipt of systemic glucocorticoids within 1 month of study enrollment, or any cytotoxic or immunosuppressive drugs within six months of study enrollment. Inhaled and topical steroids are allowed.
• A history of any demyelinating disease including Multiple Sclerosis and Guillain-Barré syndrome.
• Presence of an active neurological disorder.
• History of chronic alcohol consumption and/or drug abuse.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Sherbrooke, Quebec, J1H 1Z1, Canada

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

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 25, 2009
• First Posted: June 29, 2009
• Study Start: July 11, 2009
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: November 9, 2020
• Results First Posted: August 13, 2010

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)