Clinical trial NCT00765076: Clinical Study of the Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2186877A in People Aged 65 Years or Older
Official title: Observer-blind Immunogenicity Study of GSK Biologicals' Influenza Vaccine GSK2186877A in Elderly Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: Vaccine
Elderly
Influenza
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-10-02
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This clinical trial aims to study the immunogenicity of GSK Biologicals' influenza vaccine GSK2186877A in people aged 65 years or older.

Detailed description: The amendment to the protocol posting: minor change in one inclusion criterion and in one secondary outcome measure.

Eligibility criteria: Inclusion Criteria:

All subjects must satisfy 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 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.

Elderly adults:

• A man or woman 65 year of age or older at the time of the first vaccination.

Young adults:

* Man or woman between the ages of 18 and 40 years, inclusive.
* If the subject is female, she must be of non-childbearing potential or be post-menopausal, 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 vaccination.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) 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 a vaccine not foreseen by the study protocol up to Visit 4 after vaccination and of an influenza vaccine other than the study vaccines up to Visit 4.
* Vaccination against influenza since February 2008 with a seasonal influenza vaccine.
* Previous vaccination in the last three years with an investigational adjuvanted vaccine candidate seasonal or pandemic 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 hypersensivity to a previous dose of influenza vaccine.
* History of allergy or reactions likely to be exacerbated by any component of the vaccine(s) including egg or chicken protein.
* Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by clinical evaluation 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 first administration of the study vaccine or planned administration during the study.
* Any medical conditions in which intramuscular injections are contraindicated.
* Pregnant or lactating female.
* Female of childbearing age planning to become pregnant or planning to discontinue contraceptive precautions.
* Any medical condition that in the opinion of the investigator precludes the collection of blood volumes as required by the protocol.

Primary outcomes:
measure: The Geometric Mean (GM) Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains Which Are Producing at Least Two Different Markers
timeFrame: Day 21
Secondary outcomes:
measure: The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Which Were Producing at Least Two Different Markers
timeFrame: At Day 0, 21, 42 and 180
measure: The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker
timeFrame: At Day 0, 21, 42 and 180
measure: Haemagglutinin Inhibition (HI) Antibody Titers
timeFrame: At Day 0, 21, 42 and 180
measure: The Number of Subjects Seropositive to HI Antibodies Calculated After in Vitro Stimulation With Separate Vaccine Strains.
timeFrame: At Day 0, 21, 42 and 180
measure: The Number of Subjects Seroconverted to HI Antibodies
timeFrame: At Day 21, 42 and 180
measure: HI Antibody Seroconversion Factors
timeFrame: At Day 21, 42 and 180
measure: The Number of Subjects Seroprotected to HI Antibodies
timeFrame: At Day 0, 21, 42 and 180
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 (MAEs)
timeFrame: Day 0-179
measure: Number of Subjects Reporting Any AEs of Specific Interest (AESI)
timeFrame: Day 0-364
measure: Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
timeFrame: Day 0-364
Other outcomes:
Locations:
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Marid
country: Spain
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Couch RB, Bayas JM, Caso C, Mbawuike IN, Lopez CN, Claeys C, El Idrissi M, Herve C, Laupeze B, Oostvogels L, Moris P. Superior antigen-specific CD4+ T-cell response with AS03-adjuvantation of a trivalent influenza vaccine in a randomised trial of adults aged 65 and older. BMC Infect Dis. 2014 Jul 30;14:425. doi: 10.1186/1471-2334-14-425.