A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Seasonal Influenza Vaccine in Adults

Influenza Clinical Trial

Official title:

A Phase III Study for Evaluation of Immunogenicity and Reactogenicity of Fluarix™/Influsplit SSW® 2010/2011 in People Aged 18 Years or Above

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01144299
• Other study ID #: 114292
• Status: Completed
• Phase: Phase 3
• Start date: June 17, 2010
• Est. completion date: July 10, 2010

Study information

• Verified date: September 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to test the immunogenicity and reactogenicity of the Fluarix™/Influsplit SSW® influenza vaccine containing the influenza strains recommended for the 2010-2011 season.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: July 10, 2010
• Est. primary completion date: July 10, 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Fluarix™/Influsplit SSW®
Single intramuscular dose on Day 0

Locations

Country	Name	City	State
Germany	GSK Investigational Site	Dresden	Sachsen
Germany	GSK Investigational Site	Dresden	Sachsen
Germany	GSK Investigational Site	Dresden	Sachsen
Germany	GSK Investigational Site	Dresden	Sachsen
Germany	GSK Investigational Site	Dresden	Sachsen
Germany	GSK Investigational Site	Freital	Sachsen

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of Seroprotected Subjects	A seroprotected subject is a subject with a serum HI antibody titer = 1:40	Day 0 and Day 21
Primary	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
Primary	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
Primary	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	Number of Subjects Reporting Solicited Local Symptoms	Solicited local symptoms assessed include ecchymosis, induration, pain, redness, and swelling.	During the 4-day (Day 0-3) post-vaccination period
Secondary	Number of Subjects Reporting Solicited General Symptoms	Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, shivering, sweating, and fever.	During the 4-day (Day 0-3) post-vaccination period
Secondary	Number of Subjects Reporting Unsolicited Adverse Events (AE)	An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product	During the 21-day (Day 0-20) post-vaccination period
Secondary	Number of Subjects Reporting Serious Adverse Events (SAE)	An SAE is any untoward medical occurrence that: results in death, is lifethreatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.	During the entire study period (From Day 0 up to Day 21)

External Links

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