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

Influenza Clinical Trial

Official title:

Observer-blind Safety and Immunogenicity Study of GlaxoSmithKline Biologicals' Influenza Vaccine GSK2186877A When Administered to Elderly Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00992784
• Other study ID #: 113094
• Status: Completed
• Phase: Phase 3
• Start date: October 15, 2009
• Est. completion date: May 27, 2010

Study information

• Verified date: May 2018
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 370
• Est. completion date: May 27, 2010
• Est. primary completion date: May 27, 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

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.

Exclusion Criteria:

The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:

• 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.

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• GSK investigational vaccine 2186877A
Single dose, intramuscular injection
• FluarixTM
Single dose, intramuscular injection

Locations

Country	Name	City	State
Germany	GSK Investigational Site	Augsburg	Bayern
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Dresden	Sachsen
Germany	GSK Investigational Site	Essen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Freital	Sachsen
Germany	GSK Investigational Site	Gueglingen	Baden-Wuerttemberg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Koeln	Nordrhein-Westfalen
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Magdeburg	Sachsen-Anhalt
Germany	GSK Investigational Site	Mainz	Rheinland-Pfalz
Germany	GSK Investigational Site	Mannheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Rhaunen	Rheinland-Pfalz
Germany	GSK Investigational Site	Rudersberg	Baden-Wuerttemberg
Germany	GSK Investigational Site	Weinheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Wolmirstedt	Sachsen-Anhalt
Netherlands	GSK Investigational Site	Rotterdam
Netherlands	GSK Investigational Site	Rotterdam
Sweden	GSK Investigational Site	Eskilstuna
Sweden	GSK Investigational Site	Karlskrona
Sweden	GSK Investigational Site	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Germany,  Netherlands,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Duration of Solicited Local AEs	Duration was defined as number of days with any grade of local symptoms.	Day 0-6
Primary	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
Primary	Duration of Solicited General AEs	Duration was defined as number of days with any grade of general symptoms.	Day 0-6
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21	Antibody titers were expressed as Geometric mean titers (GMTs) against separate vaccine strains. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.	Day 0 and Day 21
Secondary	HI Antibody Titers at Day 180	Antibody titers were expressed as GMTs against separate vaccine strains. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.	Day 180
Secondary	The Number of Subjects Seropositive to HI Antibodies at Days 0 and 21	Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e = 1:10.	Day 0 and Day 21
Secondary	The Number of Subjects Seropositive to HI Antibodies at Day 180	Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e = 1:10.	Day 180
Secondary	The Number of Subjects Seroconverted to HI Antibodies at Day 21	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.	Day 21
Secondary	The Number of Subjects Seroconverted to HI Antibodies at Day 180	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.	Day 180
Secondary	HI Antibody Seroconversion Factors (SCF) at Day 21	SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.	At Day 21
Secondary	HI Antibody SCF at Day 180	SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.	At Day 180
Secondary	The Number of Subjects Seroprotected to HI Antibodies at Days 0 and 21	A seroprotected subject was defined as a subject with a serum HI titer = to 1:40 that usually is accepted as indicating protection.	At Day 0 and Day 21
Secondary	The Number of Subjects Seroprotected to HI Antibodies at Day 180	A seroprotected subject was defined as a subject with a serum HI titer = 1:40 that usually is accepted as indicating protection.	At Day 180
Secondary	The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strains Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	The markers assessed were Cluster of Differentiation 40 Ligand (CD40L), interleukin 2 (IL-2), tumour necrosis factor alpha (TNF-a) and interferon gamma (IFN-?) and vaccine strains tested included A/Brisbane, A/Uruguay and B/Brisbane antigens.	At Day 0 and Day 21
Secondary	The GM Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Day 180	The markers assessed were CD40L, IL-2, TNF-a and IFN-? and vaccine strains tested included A/Brisbane, A/Uruguay and B/Brisbane antigens.	At Day 180

External Links

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