Evaluation of the Safety and Immunogenicity of the Influenza Vaccine GSK2186877A in the Elderly - Full Text View

Purpose

The purpose of this observer-blind clinical trial is to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' influenza vaccine GSK2186877A in the elderly. Subjects were previously vaccinated (NCT00529516).

Condition	Intervention	Phase
Influenza Infection	Biological: Influenza vaccine GSK2186877A Biological: GSK Biologicals' Fluarix™	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Safety and Immunogenicity of the Influenza Vaccine GSK2186877A in the Elderly

Resource links provided by NLM:

MedlinePlus related topics: Autoimmune Diseases Flu

Drug Information available for: Influenza Vaccines

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) [ Time Frame: Day 0-6 ] [ Designated as safety issue: No ]
Grade 3 ecchymosis, redness and swelling were ≥ 100 millimeters (mm) and grade 3 pain was considerable pain at rest that prevented normal everyday activities. Any was >20 mm for ecchymosis, redness and swelling.
Duration of Solicited Local AEs [ Time Frame: Day 0-6 ] [ Designated as safety issue: No ]
Duration was defined as number of days with any grade of local symptoms.
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs [ Time Frame: Day 0-6 ] [ Designated as safety issue: No ]
Any fever was defined as oral temperature ≥38.0 degree centigrade (°C), grade 3 fever was oral temperature ≥ 39.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relationship to the study vaccination, grade 3 was defined as a general symptom that prevented normal activity. Related arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever were defined as general symptoms assessed by the investigator as causally related to the study vaccination.
Duration of Solicited General AEs [ Time Frame: Day 0-6 ] [ Designated as safety issue: No ]
Duration was defined as number of days with any grade of general symptoms.
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs [ Time Frame: Day 0-20 ] [ 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. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade. Grade 3 was defined as an unsolicited symptom that prevented normal activity. Related was an event assessed by the investigator as causally related to the study vaccination.
Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) During Day 0 to Day 20 [ Time Frame: Day 0-20 ] [ Designated as safety issue: No ]
For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as a symptom that prevented normal activity and related was a general symptom assessed by the investigator as causally related to the study vaccination.
Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Diseases From Day 0 to Day 20 [ Time Frame: Day 0-20 ] [ Designated as safety issue: No ]
AESI for safety monitoring are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Any was defined as occurrence of any symptom regardless of intensity grade.
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 0 to Day 20 [ Time Frame: Day 0-20 ] [ 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. Any was defined as occurrence of any symptom regardless of intensity grade and related was an event assessed by the investigator as causally related to the study vaccination.

Secondary Outcome Measures:

Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) Between Day 21 and Day 179 [ Time Frame: Day 21-179 ] [ Designated as safety issue: No ]
For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as a symptom that prevented normal activity and related was a general symptom assessed by the investigator as causally related to the study vaccination.
Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Diseases Between Day 21 and Day 364 [ Time Frame: Day 21-364. ] [ Designated as safety issue: No ]
AESI for safety monitoring are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as a symptom that prevented normal activity and related was a general symptom assessed by the investigator as causally related to the study vaccination.
Haemagglutination Inhibition (HI) Antibody Titers [ Time Frame: Day 0-21 ] [ Designated as safety issue: No ]
Antibody titers were expressed as Geometric mean titres (GMTs) per separate vaccine strain. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
The Number of Subjects Seropositive to HI Antibodies [ Time Frame: Day 0-21 ] [ Designated as safety issue: No ]
A seropositive subject was defined as a subject with antibody titer greater than or equal to the cut-off value i.e ≥ 1:10. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
The Number of Subjects Seroprotected by HI Antibodies [ Time Frame: Day 0-21 ] [ Designated as safety issue: No ]
A seroprotected subject was defined as a subject with a serum HI titer ≥ 1:40 that usually is accepted as indicating protection. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
The Number of Subjects Seroconverted to HI Antibodies [ Time Frame: At Day 21 ] [ Designated as safety issue: No ]
A seroconverted subject was defined as a subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
HI Antibody Seroconversion Factors (SCF) [ Time Frame: At Day 21 ] [ Designated as safety issue: No ]
SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 21 to Day 364 [ Time Frame: Day 21-364 ] [ 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. Any was defined as occurrence of any symptom regardless of intensity grade and related was an event assessed by the investigator as causally related to the study vaccination.

Enrollment:	971
Study Start Date:	October 2008
Study Completion Date:	December 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: New generation influenza vaccine GSK2186877A Group Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.	Biological: Influenza vaccine GSK2186877A One intramuscularly injection at Day 0
Active Comparator: Fluarix elderly Group Subjects aged ≥66 years received one dose of Fluarix vaccine.	Biological: GSK Biologicals' Fluarix™ One intramuscularly injection at Day 0
Active Comparator: Fluarix young Group Subjects aged 19-43 years received one dose of Fluarix vaccine.	Biological: GSK Biologicals' Fluarix™ One intramuscularly injection at Day 0

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

A male or female subject previously enrolled in study 109821 (NCT 00529516) in the >= 65 years and 18-41 years of age groups and having received the study vaccine.
Subjects of whom the investigator believes that they can and will comply with the requirements of the protocol. Specific attention should be given to the compliance potential of subjects with suspected or known drug or alcohol abuse.
Written informed consent obtained from the subject.
Free of an acute aggravation of the health status 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:

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 30 days after vaccination.
Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
Any vaccination against influenza since January 2008 with any seasonal influenza vaccine.
Chronic administration (defined as more than 14 days) 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 vaccines.
Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by 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 administration of the study vaccine or planned administration during the study period.
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days prior to vaccination, or planned use during the study period.
Any medical conditions in which intramuscular injections are contraindicated.
Pregnant or lactating females.
Female planning to become pregnant or planning to discontinue contraceptive precautions.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00772889

Locations

United States, Florida
GSK Investigational Site
Clearwater, Florida, United States, 33761
GSK Investigational Site
Coral Gables, Florida, United States, 33134
United States, Massachusetts
GSK Investigational Site
Milford, Massachusetts, United States, 01757
United States, Minnesota
GSK Investigational Site
Chaska, Minnesota, United States, 55318
United States, New Jersey
GSK Investigational Site
Somers Point, New Jersey, United States, 08244
United States, New York
GSK Investigational Site
Poughkeepsie, New York, United States, 12601
United States, Pennsylvania
GSK Investigational Site
Carnegie, Pennsylvania, United States, 15106
GSK Investigational Site
Erie, Pennsylvania, United States, 16506
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15236
Germany
GSK Investigational Site
Messkirch, Baden-Wuerttemberg, Germany, 88605
GSK Investigational Site
Augsburg, Bayern, Germany, 86150
GSK Investigational Site
Haag, Bayern, Germany, 83527
GSK Investigational Site
Hoehenkirchen-Siegertsbrunn, Bayern, Germany, 85635
GSK Investigational Site
Langquaid, Bayern, Germany, 84085
GSK Investigational Site
Ruedersdorf, Brandenburg, Germany, 15562
GSK Investigational Site
Leipzig, Sachsen, Germany, 04129
GSK Investigational Site
Berlin, Germany, 10365
GSK Investigational Site
Berlin, Germany, 10367
GSK Investigational Site
Berlin, Germany, 13086
GSK Investigational Site
Berlin, Germany, 13507
GSK Investigational Site
Berlin, Germany, 12687
Norway
GSK Investigational Site
Bekkestua, Norway, N-1357
GSK Investigational Site
Bergen, Norway, 5094
GSK Investigational Site
Elverum, Norway, 2408
GSK Investigational Site
Fredrikstad, Norway, N-1601
GSK Investigational Site
Hamar, Norway, 2317
GSK Investigational Site
Haugesund, Norway, 5528
GSK Investigational Site
Skien, Norway, 3717

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00772889 History of Changes
Other Study ID Numbers:	111738
Study First Received:	October 10, 2008
Results First Received:	March 29, 2012
Last Updated:	October 25, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Elderly
Vaccine
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 May 19, 2013