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

Safety and Immunogenicity of the Influenza Vaccine GSK2186877A in the Elderly

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).

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: Influenza vaccine GSK2186877A; Biological: GSK Biologicals' Fluarix™

• Study Type: Interventional
• Enrollment (Actual): 971
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Gent, Belgium, 9000
    • GSK Investigational Site
• Germany
  • Berlin, Germany, 10367
    • GSK Investigational Site
  • Berlin, Germany, 13086
    • GSK Investigational Site
  • Berlin, Germany, 10365
    • GSK Investigational Site
  • Berlin, Germany, 13507
    • GSK Investigational Site
  • Berlin, Germany, 12687
    • GSK Investigational Site
  • Baden-Wuerttemberg
    • Messkirch, Baden-Wuerttemberg, Germany, 88605
      • GSK Investigational Site
  • Bayern
    • 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
  • Brandenburg
    • Ruedersdorf, Brandenburg, Germany, 15562
      • GSK Investigational Site
  • Sachsen
    • Leipzig, Sachsen, Germany, 04129
      • GSK Investigational Site
• Norway
  • Bekkestua, Norway, 1319
    • 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
    • GSK Investigational Site
• United States
  • Florida
    • Clearwater, Florida, United States, 33761
      • GSK Investigational Site
    • Coral Gables, Florida, United States, 33134
      • GSK Investigational Site
  • Massachusetts
    • Milford, Massachusetts, United States, 01757
      • GSK Investigational Site
  • Minnesota
    • Chaska, Minnesota, United States, 55318
      • GSK Investigational Site
  • New Jersey
    • Somers Point, New Jersey, United States, 08244
      • GSK Investigational Site
  • New York
    • Poughkeepsie, New York, United States, 12601
      • GSK Investigational Site
  • Pennsylvania
    • Carnegie, Pennsylvania, United States, 15106
      • GSK Investigational Site
    • Erie, Pennsylvania, United States, 16506
      • GSK Investigational Site
    • Pittsburgh, Pennsylvania, United States, 15236
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) Between Day 21 and Day 179	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 21-179
Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Diseases Between Day 21 and Day 364	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.	Day 21-364.
Haemagglutination Inhibition (HI) Antibody Titers	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.	Day 0-21
The Number of Subjects Seropositive to HI Antibodies	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.	Day 0-21
The Number of Subjects Seroprotected by HI Antibodies	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.	Day 0-21
The Number of Subjects Seroconverted to HI Antibodies	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.	At Day 21
HI Antibody Seroconversion Factors (SCF)	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.	At Day 21
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 21 to Day 364	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 21-364

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

Helpful 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.

Study record dates

Study Major Dates

• Study Start: October 9, 2008
• Primary Completion (ACTUAL): December 15, 2009
• Study Completion (ACTUAL): December 15, 2009

Study Registration Dates

• First Submitted: October 10, 2008
• First Submitted That Met QC Criteria: October 14, 2008
• First Posted (ESTIMATE): October 15, 2008

Study Record Updates

• Last Update Posted (ACTUAL): July 31, 2018
• Last Update Submitted That Met QC Criteria: July 2, 2018
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Elderly; Influenza; Vaccine
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: 111738

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

1. Individual Participant Data Set
   Information identifier: 111738
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Informed Consent Form
   Information identifier: 111738
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Annotated Case Report Form
   Information identifier: 111738
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Dataset Specification
   Information identifier: 111738
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Clinical Study Report
   Information identifier: 111738
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Study Protocol
   Information identifier: 111738
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
7. Statistical Analysis Plan
   Information identifier: 111738
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register