A Study for Evaluation of Immunogenicity and Reactogenicity of FluarixTM / Influsplit SSW® 2009/2010 in Adults

NCT00920374 | Completed Phase 3 Results

• 1 other identifier: 113018
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 5

Brief Summary

This study is designed to test the immunogenicity and reactogenicity of the FluarixTM/Influsplit SSW® influenza vaccine containing the influenza strains recommended for the 2009-2010 season.

Conditions

Influenza

Keywords

Influenza

Outcome Measures

Primary Outcomes (6)

• Hemagglutination Inhibition (HI) Antibody Titer

  Titers given as geometric mean titer (GMT) were presented for all three vaccine influenza virus strains

  Day 0 and Day 21

• Number of Subjects With HI Antibody Titer Above the Cut-off Value

  The cut-off value assessed was ≥ 1:10 and was presented for all three vaccine influenza virus strains

  Day 0 and Day 21

• Number of Seroprotected Subjects

  A seroprotected subject is a subject with a serum HI antibody titer ≥ 1:40

  Day 0 and Day 21

• Number of Seroconverted Subjects

  A seroconverted subject is a subject with 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 a fold increase (Day 21/Day 0) ≥ 4

  Day 21

• Seroconversion Factor

  Seroconversion factor, defined as the fold increase in serum HI GMT post-vaccination compared to pre-vaccination (Day 0), is presented for all three vaccine influenza virus strains

  Day 21

• Seroprotection Power

  Seroprotection power is defined as the number of subject who had a pre-vaccination titer \< 1:40 and a post-vaccination titer ≥ 1:40

  Day 21

Secondary Outcomes (4)

• Number of Subjects Reporting Solicited Local Symptoms

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

• Number of Subjects Reporting Solicited General 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 entire study period

Study Arms (2)

Fluarix Adult Group

EXPERIMENTAL

Subjects who are 18-60 years of age received one dose of Fluarix™

Biological: Fluarix™/Influsplit SSW®

Fluarix Elderly Group

EXPERIMENTAL

Subjects who are \> 60 years of age received one dose of Fluarix™

Biological: Fluarix™/Influsplit SSW®

Interventions

Fluarix™/Influsplit SSW® BIOLOGICAL

single intramuscular dose on Day 0

Fluarix Adult Group; Fluarix 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 should be enrolled in the study.
• A male or female aged 18 years or above at the time of the vaccination.
• Written informed consent obtained from the subject.
• Healthy subjects or with well-controlled chronic diseases as established by medical history and clinical examination before entering into the study.
• If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.

You may not qualify if:

• Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the vaccination or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.
• Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned during the study.
• Administration of an influenza vaccine within 6 months preceding the study start.
• Administration of an influenza vaccine other than the study vaccine during the entire study
• Clinically or virologically confirmed influenza infection within 6 months preceding the study start
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• Acute disease at the time of enrolment.
• Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
• Not stabilized or clinically serious chronic underlying disease.
• Lactating female.
• History of chronic alcohol consumption and/or drug abuse.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (5)

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, 01307, Germany

Location

GSK Investigational Site

Freital, Saxony, 01705, Germany

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

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 12, 2009
• First Posted: June 15, 2009
• Study Start: June 16, 2009
• Primary Completion: July 8, 2009
• Study Completion: July 8, 2009
• Last Updated: September 21, 2018
• Results First Posted: July 27, 2010

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

DE (5)