Evaluation of the Safety and Immunogenicity of the Influenza Vaccine GSK2186877A in the Elderly

NCT00772889 | Completed Phase 3 Results

• 1 other identifier: 111738
• Study Type: interventional
• Target: 971
• Locations: 4 countries
• Sites: 29

Brief Summary

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).

Conditions

Influenza

Keywords

Elderly; Vaccine; Influenza

Outcome Measures

Primary Outcomes (8)

• Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)

  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.

  Day 0-6

• Duration of Solicited Local AEs

  Duration was defined as number of days with any grade of local symptoms.

  Day 0-6

• Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs

  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.

  Day 0-6

• Duration of Solicited General AEs

  Duration was defined as number of days with any grade of general symptoms.

  Day 0-6

• Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs

  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.

  Day 0-20

• Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) During Day 0 to Day 20

  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.

  Day 0-20

• Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Diseases From Day 0 to Day 20

  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.

  Day 0-20

• Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 0 to Day 20

  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.

  Day 0-20

Secondary Outcomes (8)

• Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) Between Day 21 and Day 179

  Day 21-179

• Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Diseases Between Day 21 and Day 364

  Day 21-364.

• Haemagglutination Inhibition (HI) Antibody Titers

  Day 0-21

• The Number of Subjects Seropositive to HI Antibodies

  Day 0-21

• The Number of Subjects Seroprotected by HI Antibodies

  Day 0-21

Study Arms (3)

New generation influenza vaccine GSK2186877A Group

EXPERIMENTAL

Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.

Biological: Influenza vaccine GSK2186877A

Fluarix elderly Group

ACTIVE COMPARATOR

Subjects aged ≥66 years received one dose of Fluarix vaccine.

Biological: GSK Biologicals' Fluarix™

Fluarix young Group

ACTIVE COMPARATOR

Subjects aged 19-43 years received one dose of Fluarix vaccine.

Biological: GSK Biologicals' Fluarix™

Interventions

Influenza vaccine GSK2186877A BIOLOGICAL

One intramuscularly injection at Day 0

New generation influenza vaccine GSK2186877A Group

GSK Biologicals' Fluarix™ BIOLOGICAL

One intramuscularly injection at Day 0

Fluarix elderly Group; Fluarix young Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (29)

GSK Investigational Site

Clearwater, Florida, 33761, United States

Location

GSK Investigational Site

Coral Gables, Florida, 33134, United States

Location

GSK Investigational Site

Milford, Massachusetts, 01757, United States

Location

GSK Investigational Site

Chaska, Minnesota, 55318, United States

Location

GSK Investigational Site

Somers Point, New Jersey, 08244, United States

Location

GSK Investigational Site

Poughkeepsie, New York, 12601, United States

Location

GSK Investigational Site

Carnegie, Pennsylvania, 15106, United States

Location

GSK Investigational Site

Erie, Pennsylvania, 16506, United States

Location

GSK Investigational Site

Pittsburgh, Pennsylvania, 15236, United States

Location

GSK Investigational Site

Ghent, 9000, Belgium

Location

GSK Investigational Site

Messkirch, Baden-Wurttemberg, 88605, Germany

Location

GSK Investigational Site

Augsburg, Bavaria, 86150, Germany

Location

GSK Investigational Site

Haag, Bavaria, 83527, Germany

Location

GSK Investigational Site

Höhenkirchen-Siegertsbrunn, Bavaria, 85635, Germany

Location

GSK Investigational Site

Langquaid, Bavaria, 84085, Germany

Location

GSK Investigational Site

Rüdersdorf, Brandenburg, 15562, Germany

Location

GSK Investigational Site

Leipzig, Saxony, 04129, Germany

Location

GSK Investigational Site

Berlin, 10365, Germany

Location

GSK Investigational Site

Berlin, 10367, Germany

Location

GSK Investigational Site

Berlin, 12687, Germany

Location

GSK Investigational Site

Berlin, 13086, Germany

Location

GSK Investigational Site

Berlin, 13507, Germany

Location

GSK Investigational Site

Bekkestua, 1319, Norway

Location

GSK Investigational Site

Bergen, 5094, Norway

Location

GSK Investigational Site

Elverum, 2408, Norway

Location

GSK Investigational Site

Fredrikstad, N-1601, Norway

Location

GSK Investigational Site

Hamar, 2317, Norway

Location

GSK Investigational Site

Haugesund, 5528, Norway

Location

GSK Investigational Site

Skien, 3717, Norway

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: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2008
• First Posted: October 15, 2008
• Study Start: October 9, 2008
• Primary Completion: December 15, 2009
• Study Completion: December 15, 2009
• Last Updated: July 31, 2018
• Results First Posted: April 24, 2012

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share

Locations

US (9); NO (7); DE (12); BE (1)