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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 Markers

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

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

Page last updated: August 20, 2015

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