Clinical Study of the Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2186877A in People Aged 65 Years or Older
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Influenza Infection
Intervention: GSK Biologicals' influenza vaccine GSK2186877A (Biological); GSK Biologicals' Fluarix (Biological)
Phase: Phase 3
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s): GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
Summary
This clinical trial aims to study the immunogenicity of GSK Biologicals' influenza vaccine
GSK2186877A in people aged 65 years or older.
Clinical Details
Official title: Observer-blind Immunogenicity Study of GSK Biologicals' Influenza Vaccine GSK2186877A in Elderly Subjects
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: 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
Secondary outcome: 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 MarkersThe 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 Haemagglutinin Inhibition (HI) Antibody Titers The Number of Subjects Seropositive to HI Antibodies Calculated After in Vitro Stimulation With Separate Vaccine Strains. The Number of Subjects Seroconverted to HI Antibodies HI Antibody Seroconversion Factors The Number of Subjects Seroprotected to HI Antibodies Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Duration of Solicited Local AEs Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Duration of Solicited General AEs Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) Number of Subjects Reporting Any AEs of Specific Interest (AESI) Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Detailed description:
The amendment to the protocol posting: minor change in one inclusion criterion and in one
secondary outcome measure.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
GSK Investigational Site, Barcelona 08035, Spain
GSK Investigational Site, Madrid 28046, Spain
GSK Investigational Site, Marid 28040, Spain
GSK Investigational Site, Houston, Texas 77030, United States
Additional Information
Starting date: October 2008
Last updated: June 14, 2012
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