Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline Biologicals' Influenza Vaccine in Elderly People

NCT00992784 | Completed Phase 3 Results

• 1 other identifier: 113094
• Study Type: interventional
• Target: 370
• Locations: 3 countries
• Sites: 24

Brief Summary

The purpose of the study is to evaluate the safety of GSK Biologicals' influenza vaccine. Elderly subjects were randomized in the primary study (NCT00760617) and will now receive the same vaccine for the third time. For this study the masking is "observer-blind" for elderly subjects and "open" for young adult subjects.

Conditions

Influenza

Keywords

Influenza Vaccines; GSK Bio's influenza vaccine GSK2186877A; influenza infection

Outcome Measures

Primary Outcomes (9)

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

  Grade 3 ecchymosis, redness and swelling was ≥ 100 millimeter (mm) and grade 3 pain was considerable pain at rest, that prevented normal everyday activities.

  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-≤ 40.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade, grade 3 was defined as general symptom that prevented normal activity and related was general symptom 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 unsolicited symptom that prevented normal activity and related was 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

  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 symptom that prevented normal activity and related was general symptom assessed by the investigator as causally related to the study vaccination.

  Day 0-179

• Number of Subjects Reporting AEs of Specific Interest (AESI)

  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 symptom that prevented normal activity and related was general symptom assessed by the investigator as causally related to the study vaccination.

  Day 0-179

• Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) up to Day 180

  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 event assessed by the investigator as causally related to the study vaccination.

  Up to Day 180

• Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) After Day 180

  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 event assessed by the investigator as causally related to the study vaccination.

  After Day 180

Secondary Outcomes (12)

• Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21

  Day 0 and Day 21

• HI Antibody Titers at Day 180

  Day 180

• The Number of Subjects Seropositive to HI Antibodies at Days 0 and 21

  Day 0 and Day 21

• The Number of Subjects Seropositive to HI Antibodies at Day 180

  Day 180

• The Number of Subjects Seroconverted to HI Antibodies at Day 21

  Day 21

Study Arms (3)

New generation influenza vaccine GSK2186877A Group

EXPERIMENTAL

Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A

Biological: GSK investigational vaccine 2186877A

Fluarix elderly Group

ACTIVE COMPARATOR

Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine

Biological: FluarixTM

Fluarix young Group

ACTIVE COMPARATOR

Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine

Biological: FluarixTM

Interventions

GSK investigational vaccine 2186877A BIOLOGICAL

Single dose, intramuscular injection

New generation influenza vaccine GSK2186877A Group

FluarixTM BIOLOGICAL

Single dose, intramuscular injection

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:

• All subjects must satisfy ALL the following criteria at study entry:
• Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. Specific attention should be given to the compliance potential of subjects with suspected drug or alcohol abuse.
• A male or female aged 19-43 years or \>=66 years at the time of the vaccination and who participated in the study NCT00760617 and completed the 6-month follow-up.
• Written informed consent obtained from the subject.
• Free of an acute aggravation of the health status as established by clinical evaluation before entering into the study.
• Female subjects of non-childbearing potential may be enrolled in the study.
• Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
• Female subjects of childbearing potential may be enrolled in the study if the subject:
• has practiced adequate contraception for 30 days prior to vaccination, and
• has a negative pregnancy test on the day of vaccination, and
• has agreed to continue adequate contraception for 2 months after the vaccination.

You may not qualify if:

• Use of any investigational or non-registered product other than the study vaccine(s) within 30 days prior to vaccination, 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 an influenza vaccine other than the study vaccines or of a vaccine not foreseen in the study protocol during the entire study period.
• Vaccination against influenza since January 2009 with a seasonal influenza vaccine.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• History of hypersensivity to a previous dose of influenza vaccine.
• History of allergy or reactions likely to be exacerbated by any component of the vaccine(s).
• Acute clinically significant pulmonary, cardiovascular, hepatic, renal, neurological and psychiatric disorders, as determined by clinical evaluation or pre-existing laboratory screening tests.
• Acute disease and/or fever at the time of enrolment.
• Fever is defined as temperature \>=37.5°C on oral setting.
• Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
• 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.
• Any medical conditions in which IM injections are contraindicated
• Pregnant or lactating female.
• Female planning to become pregnant or planning to discontinue contraceptive precautions.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (24)

GSK Investigational Site

Güglingen, Baden-Wurttemberg, 74363, Germany

Location

GSK Investigational Site

Mannheim, Baden-Wurttemberg, 68161, Germany

Location

GSK Investigational Site

Rudersberg, Baden-Wurttemberg, 73635, Germany

Location

GSK Investigational Site

Weinheim, Baden-Wurttemberg, 69469, Germany

Location

GSK Investigational Site

Augsburg, Bavaria, 86150, Germany

Location

GSK Investigational Site

Cologne, North Rhine-Westphalia, 51069, Germany

Location

GSK Investigational Site

Essen, North Rhine-Westphalia, 45359, Germany

Location

GSK Investigational Site

Mainz, Rhineland-Palatinate, 55131, Germany

Location

GSK Investigational Site

Rhaunen, Rhineland-Palatinate, 55624, Germany

Location

GSK Investigational Site

Dresden, Saxony, 01067, Germany

Location

GSK Investigational Site

Freital, Saxony, 01705, Germany

Location

GSK Investigational Site

Leipzig, Saxony, 04103, Germany

Location

GSK Investigational Site

Magdeburg, Saxony-Anhalt, 39112, Germany

Location

GSK Investigational Site

Wolmirstedt, Saxony-Anhalt, 39326, Germany

Location

GSK Investigational Site

Berlin, 10435, Germany

Location

GSK Investigational Site

Berlin, 12627, Germany

Location

GSK Investigational Site

Berlin, 13347, Germany

Location

GSK Investigational Site

Hamburg, 22335, Germany

Location

GSK Investigational Site

Hamburg, 22415, Germany

Location

GSK Investigational Site

Rotterdam, 3011 AA, Netherlands

Location

GSK Investigational Site

Rotterdam, 3011 EN, Netherlands

Location

GSK Investigational Site

Eskilstuna, SE-631 88, Sweden

Location

GSK Investigational Site

Karlskrona, SE-371 41, Sweden

Location

GSK Investigational Site

Uppsala, SE-751 85, Sweden

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: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2009
• First Posted: October 9, 2009
• Study Start: October 15, 2009
• Primary Completion: May 27, 2010
• Study Completion: May 27, 2010
• Last Updated: September 21, 2018
• Results First Posted: April 5, 2012

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will share

Locations

SE (3); DE (19); NL (2)