Immunogenicity and Safety Study of GSK Biologicals' Fluviral® (2008 - 2009 Season) in Adults Over 18 Years

NCT00718120 | Completed Phase 3 Results

• 1 other identifier: 110584
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the immunogenicity and safety of GSK Biologicals' Trivalent split virion influenza vaccine Fluviral for the 2008-2009 season in adults over the age of 18.

Conditions

Influenza Vaccines

Keywords

Fluviral; Influenza

Outcome Measures

Primary Outcomes (4)

• Hemagglutination Inhibition (HI) Antibody Titers

  Titers, given as geometric mean titers (GMTs), are presented for all three vaccine influenza virus strains.

  At Day 0 and 21

• Number of Seroconverted Subjects

  Seroconversion, defined as a pre-vaccination serum HI titer \< 1:10 and a post-vaccination serum HI titer ≥ 1:40, or a pre-vaccination serum HI titer ≥ 1:10 and at least a 4-fold increase in post-vaccination serum HI titer, is presented for all three vaccine influenza virus strains.

  At Day 21

• Number of Seroprotected Subjects

  Seroprotection, defined as a serum HI antibody titer ≥ 1:40, is presented for all three vaccine influenza virus strains.

  At Day 0 and 21

• Fold Increase From Baseline in Serum HI Antibody Titer

  The fold increase in serum HI antibody titer post-vaccination (Day 21) compared to pre-vaccination (Day 0) was calculated by dividing the geometric mean antibody titers of Day 21 by those of Day 0. Data are presented for all three vaccine influenza virus strains.

  At Day 21

Secondary Outcomes (3)

• Number of Subjects Reporting Solicited Symptoms

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

• Number of Subjects Reporting Unsolicited Adverse Events (AE)

  During the 21-day (Day 0-20) post-vaccination period

• Number of Subjects Reporting Serious Adverse Events (SAE)

  During the 21-day (Day 0-20) post-vaccination period

Study Arms (2)

Fluviral Adult Group

EXPERIMENTAL

Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.

Biological: Fluviral®

Fluviral Elderly Group

EXPERIMENTAL

Subjects aged more than 60 years received a single dose of Fluviral® vaccine.

Biological: Fluviral®

Interventions

Fluviral® BIOLOGICAL

One intramuscular injection into the deltoid region of the non-dominant arm

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 can and will comply with the requirements of the protocol.
• Male and female adults, 18 to 60 years of age and over 60 years of age.
• Written informed consent obtained from the subject.
• 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.

You may not qualify if:

• Acute disease at the time of enrollment.
• Significant acute or chronic, uncontrolled medical or psychiatric illness.
• 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 hemaglobinopathies 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.
• Any significant disorder of coagulation that increases the risk of intramuscular injections or treatment with coumadin derivatives or heparin. Persons receiving prophylactic antiplatelet medications, e.g. low-dose aspirin, and without a clinically-apparent bleeding tendency are eligible.

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: July 17, 2008
• First Posted: July 18, 2008
• Study Start: July 18, 2008
• Primary Completion: August 9, 2008
• Study Completion: August 9, 2008
• Last Updated: June 26, 2019
• Results First Posted: August 25, 2009

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)