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

NCT ID: NCT00765076

Last Updated: 2018-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-16
• Study Completion Date: 2009-12-04

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.

Conditions

Influenza

Study Design

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

Study Groups

New generation influenza vaccine GSK2186877A Group

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

Group Type: EXPERIMENTAL

GSK Biologicals' influenza vaccine GSK2186877A

Intervention Type: BIOLOGICAL

One intramuscular injection at Day 0

Fluarix elderly Group

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

Group Type: ACTIVE_COMPARATOR

GSK Biologicals' Fluarix

Intervention Type: BIOLOGICAL

One intramuscular injection at Day 0

Fluarix young Group

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

Group Type: ACTIVE_COMPARATOR

GSK Biologicals' Fluarix

Intervention Type: BIOLOGICAL

One intramuscular injection at Day 0

Interventions

GSK Biologicals' influenza vaccine GSK2186877A

One intramuscular injection at Day 0

Intervention Type: BIOLOGICAL

GSK Biologicals' Fluarix

One intramuscular injection at Day 0

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 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

Houston, Texas, United States

GSK Investigational Site

Barcelona, , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Marid, , Spain

Countries

United States; Spain

References

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.

Reference Type: DERIVED

PMID: 25078387 (View on PubMed)

Study Documents

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: Informed Consent Form

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

View Document

Document Type: Individual Participant Data Set

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

112147

Identifier Type: -

Identifier Source: org_study_id