Clinical trial NCT00992784: Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline Biologicals' Influenza Vaccine in Elderly People
Official title: Observer-blind Safety and Immunogenicity Study of GlaxoSmithKline Biologicals' Influenza Vaccine GSK2186877A When Administered to Elderly Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: Influenza Vaccines
GSK Bio's influenza vaccine GSK2186877A
influenza infection
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-10-09
Enrollment: 370
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
timeFrame: Day 0-6
measure: Duration of Solicited Local AEs
timeFrame: Day 0-6
measure: Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
timeFrame: Day 0-6
measure: Duration of Solicited General AEs
timeFrame: Day 0-6
measure: Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs
timeFrame: Day 0-20
measure: Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit
timeFrame: Day 0-179
measure: Number of Subjects Reporting AEs of Specific Interest (AESI)
timeFrame: Day 0-179
measure: Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) up to Day 180
timeFrame: Up to Day 180
measure: Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) After Day 180
timeFrame: After Day 180
Secondary outcomes:
measure: Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21
timeFrame: Day 0 and Day 21
measure: HI Antibody Titers at Day 180
timeFrame: Day 180
measure: The Number of Subjects Seropositive to HI Antibodies at Days 0 and 21
timeFrame: Day 0 and Day 21
measure: The Number of Subjects Seropositive to HI Antibodies at Day 180
timeFrame: Day 180
measure: The Number of Subjects Seroconverted to HI Antibodies at Day 21
timeFrame: Day 21
measure: The Number of Subjects Seroconverted to HI Antibodies at Day 180
timeFrame: Day 180
measure: HI Antibody Seroconversion Factors (SCF) at Day 21
timeFrame: At Day 21
measure: HI Antibody SCF at Day 180
timeFrame: At Day 180
measure: The Number of Subjects Seroprotected to HI Antibodies at Days 0 and 21
timeFrame: At Day 0 and Day 21
measure: The Number of Subjects Seroprotected to HI Antibodies at Day 180
timeFrame: At Day 180
measure: 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
timeFrame: At Day 0 and Day 21
measure: 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
timeFrame: At Day 180
Other outcomes:
Locations:
city: Gueglingen
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Mannheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Rudersberg
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Weinheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Augsburg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Essen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Koeln
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Mainz
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Rhaunen
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Magdeburg
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Wolmirstedt
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Freital
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Rotterdam
country: Netherlands
facility: GSK Investigational Site
city: Rotterdam
country: Netherlands
facility: GSK Investigational Site
city: Eskilstuna
country: Sweden
facility: GSK Investigational Site
city: Karlskrona
country: Sweden
facility: GSK Investigational Site
city: Uppsala
country: Sweden
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: