Evaluation of the Safety and Immunogenicity of the Influenza Vaccine GSK2186877A in the Elderly

NCT ID: NCT00772889

Last Updated: 2018-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 971 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-09
• Study Completion Date: 2009-12-15

Brief Summary

The purpose of this observer-blind clinical trial is to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' influenza vaccine GSK2186877A in the elderly. Subjects were previously vaccinated (NCT00529516).

Conditions

Influenza

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

New generation influenza vaccine GSK2186877A Group

Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.

Group Type: EXPERIMENTAL

Influenza vaccine GSK2186877A

Intervention Type: BIOLOGICAL

One intramuscularly injection at Day 0

Fluarix elderly Group

Subjects aged ≥66 years received one dose of Fluarix vaccine.

Group Type: ACTIVE_COMPARATOR

GSK Biologicals' Fluarix™

Intervention Type: BIOLOGICAL

One intramuscularly injection at Day 0

Fluarix young Group

Subjects aged 19-43 years received one dose of Fluarix vaccine.

Group Type: ACTIVE_COMPARATOR

GSK Biologicals' Fluarix™

Intervention Type: BIOLOGICAL

One intramuscularly injection at Day 0

Interventions

Influenza vaccine GSK2186877A

One intramuscularly injection at Day 0

Intervention Type: BIOLOGICAL

GSK Biologicals' Fluarix™

One intramuscularly injection at Day 0

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• A male or female subject previously enrolled in study 109821 (NCT 00529516) in the >= 65 years and 18-41 years of age groups and having received the study vaccine.
• Subjects of whom the investigator believes that they can and will comply with the requirements of the protocol. 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
• If the subject is female, she must be of non-childbearing potential 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 completion of the vaccination series.

Exclusion Criteria

• 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 30 days after vaccination.
• Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
• Any vaccination against influenza since January 2008 with any seasonal 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 hypersensitivity to a previous dose of influenza vaccine.
• History of allergy or reactions likely to be exacerbated by any component of the vaccines.
• Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination 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 administration of the study vaccine or planned administration during the study period.
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days prior to vaccination, or planned use during the study period.
• Any medical conditions in which intramuscular injections are contraindicated.
• Pregnant or lactating females.
• Female planning to become pregnant or planning to discontinue contraceptive precautions.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Clearwater, Florida, United States

GSK Investigational Site

Coral Gables, Florida, United States

GSK Investigational Site

Milford, Massachusetts, United States

GSK Investigational Site

Chaska, Minnesota, United States

GSK Investigational Site

Somers Point, New Jersey, United States

GSK Investigational Site

Poughkeepsie, New York, United States

GSK Investigational Site

Carnegie, Pennsylvania, United States

GSK Investigational Site

Erie, Pennsylvania, United States

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

GSK Investigational Site

Ghent, , Belgium

GSK Investigational Site

Messkirch, Baden-Wurttemberg, Germany

GSK Investigational Site

Augsburg, Bavaria, Germany

GSK Investigational Site

Haag, Bavaria, Germany

GSK Investigational Site

Höhenkirchen-Siegertsbrunn, Bavaria, Germany

GSK Investigational Site

Langquaid, Bavaria, Germany

GSK Investigational Site

Rüdersdorf, Brandenburg, Germany

GSK Investigational Site

Leipzig, Saxony, Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Bekkestua, , Norway

GSK Investigational Site

Bergen, , Norway

GSK Investigational Site

Elverum, , Norway

GSK Investigational Site

Fredrikstad, , Norway

GSK Investigational Site

Hamar, , Norway

GSK Investigational Site

Haugesund, , Norway

GSK Investigational Site

Skien, , Norway

Countries

United States; Belgium; Germany; Norway

Study Documents

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

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

Other Identifiers

111738

Identifier Type: -

Identifier Source: org_study_id