Non-inferiority Study of GSK Biologicals' Influenza Vaccine GSK576389A Using Different Formulations - Full Text View

Purpose

The purpose of this study is to show the non-inferiority of different formulations of GlaxoSmithKline Biologicials' influenza vaccine.

Condition	Intervention	Phase
Influenza Infection	Biological: Thiomersal-free FluAS25 adjuvanted vaccine (GSK576389A) Biological: Thiomersal reduced FluAS25 adjuvanted vaccine (GSK576389A)	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Non-inferiority Study of GlaxoSmithKline Biologicals' Influenza Vaccine GSK576389A Using Different Formulations.

Resource links provided by NLM:

MedlinePlus related topics: Flu

Drug Information available for: Thimerosal Influenza Vaccines

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Serum Haemagglutination-inhibition (HI) Antibody Titer Against the Three Vaccine Strains [ Time Frame: Days 0 and 21 ] [ Designated as safety issue: No ]
Titers were expressed as Geometric Mean Titers (GMTs). The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.

Secondary Outcome Measures:

Number of Subjects Seropositive for HI Antibodies Against the Three Vaccine Strains [ Time Frame: Days 0 and 21 ] [ Designated as safety issue: No ]
A seropositive subject was defined as a subject with a serum HI titer greater than or equal to 1:10. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
Number of Subjects Seroconverted for HI Antibodies Against the Three Vaccine Strains [ Time Frame: Day 21 ] [ Designated as safety issue: No ]
A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a four-fold increase in post-vaccination titer. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
HI Antibody Seroconversion Factors [ Time Frame: Day 21 ] [ Designated as safety issue: No ]
Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
Number of Subjects Seroprotected for HI Antibodies Against the Three Vaccine Strains [ Time Frame: Days 0 and 21 ] [ Designated as safety issue: No ]
A seroprotected subject was defined as a suject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms [ Time Frame: During a 7-day period after vaccination ] [ Designated as safety issue: No ]
Solicited local symptoms assessed include ecchymosis, pain, redness and swelling. Any: any symptom regardless of intensity grade. Grade 3 pain: considerable pain at rest, which prevented normal everyday activities. Grade 3 ecchymosis, redness and swelling: more than 100 millimeter.
Duration of Solicited Local Symptoms [ Time Frame: During a 7-day period after vaccination ] [ Designated as safety issue: No ]
Duration was expressed as median number of days the symptom persisted. Solicited local symptoms assessed include ecchymosis, pain, redness and swelling.
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms [ Time Frame: During a 7-day period after vaccination ] [ Designated as safety issue: No ]
Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any: any symptom regardless of intensity grade; any fever: oral temperature greater than or equal to 38 degrees Celsius (°C). Grade 3: symptoms that prevented normal activity ; Grade 3 fever: oral temperature greater than 39°C. Related: symptom assessed by the investigator as causally related to the study vaccination.
Duration of Solicited General Symptoms [ Time Frame: During a 7-day period after vaccination ] [ Designated as safety issue: No ]
Duration was expressed as median number of days the symptom persisted. Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever.
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) [ Time Frame: During a 21-day period after vaccination ] [ Designated as safety issue: No ]
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs) [ Time Frame: During a 21-day period after vaccination ] [ Designated as safety issue: No ]
Medically Significant Conditions (MSCs) included all unsolicited adverse events that resulted in a medically attended visit.
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) [ Time Frame: During the entire study period (up to Day 21) ] [ Designated as safety issue: No ]
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.

Enrollment:	720
Study Start Date:	March 2008
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Thiomersal-free FluAS25 adjuvanted vaccine group Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine	Biological: Thiomersal-free FluAS25 adjuvanted vaccine (GSK576389A) Intramuscular administration, 1 dose
Experimental: Thiomersal reduced FluAS25 adjuvanted vaccine group Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine	Biological: Thiomersal reduced FluAS25 adjuvanted vaccine (GSK576389A) Intramuscular administration, 1 dose

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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 65 years of age or older at the time of vaccination.
Written informed consent obtained from the subject.
Free of an acute aggravation of the health status as established by clinical evaluation (medical history and medical history directed examination) before entering into the study.

Exclusion Criteria:

Suspected (based on clinical symptoms) or confirmed (based on laboratory results) influenza infection within the last 6 months.
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 21 days after vaccination.
Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
Previous vaccination against influenza with any seasonal vaccine since July 2007.
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
History of hypersensitivity to a previous dose of influenza vaccine.
History of allergy or reactions likely to be exacerbated by any component of the vaccine(s) including egg and chicken protein.
Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by clinical evaluation (medical history and medical history directed physical examination) or pre-existing laboratory screening tests.
Acute disease at the time of enrolment.
Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
Any medical conditions in which IM injections are contraindicated

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00633074

Locations

Estonia
GSK Investigational Site
Saku, Estonia, 75501
GSK Investigational Site
Tallinn, Estonia, 13419
GSK Investigational Site
Tartu, Estonia, 50417

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00633074 History of Changes
Other Study ID Numbers:	111454
Study First Received:	February 29, 2008
Results First Received:	April 26, 2012
Last Updated:	April 26, 2012
Health Authority:	Estonia: The State Agency of Medicine

Keywords provided by GlaxoSmithKline:

Influenza

Additional relevant MeSH terms:

Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections

Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 18, 2013