Clinical Study of the Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2186877A in People Aged 65 Years or Older

NCT00765076 | Completed Phase 3 Results

• 1 other identifier: 112147
• Study Type: interventional
• Target: 192
• Locations: 2 countries
• Sites: 4

Brief Summary

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

Conditions

Influenza

Keywords

Vaccine; Elderly; Influenza

Outcome Measures

Primary Outcomes (1)

• 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

  The markers assessed were Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α), interferon-gamma (IFN-γ)

  Day 21

Secondary Outcomes (15)

• 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

  At Day 0, 21, 42 and 180

• 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

  At Day 0, 21, 42 and 180

• Haemagglutinin Inhibition (HI) Antibody Titers

  At Day 0, 21, 42 and 180

• The Number of Subjects Seropositive to HI Antibodies Calculated After in Vitro Stimulation With Separate Vaccine Strains.

  At Day 0, 21, 42 and 180

• The Number of Subjects Seroconverted to HI Antibodies

  At Day 21, 42 and 180

Study Arms (3)

New generation influenza vaccine GSK2186877A Group

EXPERIMENTAL

Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0

Biological: GSK Biologicals' influenza vaccine GSK2186877A

Fluarix elderly Group

ACTIVE COMPARATOR

Subjects aged \>= 65 years receiving 1 dose of Fluarix vaccine at Day 0

Biological: GSK Biologicals' Fluarix

Fluarix young Group

ACTIVE COMPARATOR

Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0

Biological: GSK Biologicals' Fluarix

Interventions

GSK Biologicals' influenza vaccine GSK2186877A BIOLOGICAL

One intramuscular injection at Day 0

New generation influenza vaccine GSK2186877A Group

GSK Biologicals' Fluarix BIOLOGICAL

One intramuscular injection at Day 0

Fluarix elderly Group; Fluarix young Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (4)

GSK Investigational Site

Houston, Texas, 77030, United States

Location

GSK Investigational Site

Barcelona, 08035, Spain

Location

GSK Investigational Site

Madrid, 28046, Spain

Location

GSK Investigational Site

Marid, 28040, Spain

Location

Related Publications (1)

• 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.

  PMID: 25078387 DERIVED

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2008
• First Posted: October 2, 2008
• Study Start: October 16, 2008
• Primary Completion: December 4, 2009
• Study Completion: December 4, 2009
• Last Updated: July 31, 2018
• Results First Posted: April 5, 2012

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

ES (3); US (1)