Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline Biologicals' Influenza Vaccine in Elderly People

NCT ID: NCT00992784

Last Updated: 2018-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 370 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-15
• Study Completion Date: 2010-05-27

Brief Summary

The purpose of the study is to evaluate the safety of GSK Biologicals' influenza vaccine. Elderly subjects were randomized in the primary study (NCT00760617) and will now receive the same vaccine for the third time. For this study the masking is "observer-blind" for elderly subjects and "open" for young adult subjects.

Conditions

Influenza

Study Design

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

Study Groups

New generation influenza vaccine GSK2186877A Group

Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A

Group Type: EXPERIMENTAL

GSK investigational vaccine 2186877A

Intervention Type: BIOLOGICAL

Single dose, intramuscular injection

Fluarix elderly Group

Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine

Group Type: ACTIVE_COMPARATOR

FluarixTM

Intervention Type: BIOLOGICAL

Single dose, intramuscular injection

Fluarix young Group

Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine

Group Type: ACTIVE_COMPARATOR

FluarixTM

Intervention Type: BIOLOGICAL

Single dose, intramuscular injection

Interventions

GSK investigational vaccine 2186877A

Single dose, intramuscular injection

Intervention Type: BIOLOGICAL

FluarixTM

Single dose, intramuscular injection

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

All subjects must satisfy ALL 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 drug or alcohol abuse.
• A male or female aged 19-43 years or >=66 years at the time of the vaccination and who participated in the study NCT00760617 and completed the 6-month follow-up.
• Written informed consent obtained from the subject.
• Free of an acute aggravation of the health status as established by clinical evaluation before entering into the study.
• Female subjects of non-childbearing potential may be enrolled in the study.
• Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
• Female subjects of childbearing potential may be enrolled in the study if the subject:
• has practiced adequate contraception for 30 days prior to vaccination, and
• has a negative pregnancy test on the day of vaccination, and
• has agreed to continue adequate contraception for 2 months after the vaccination.

Exclusion Criteria

The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:

• Use of any investigational or non-registered product 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 an influenza vaccine other than the study vaccines or of a vaccine not foreseen in the study protocol during the entire study period.
• Vaccination against influenza since January 2009 with a seasonal influenza vaccine.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine.
• 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).
• Acute clinically significant pulmonary, cardiovascular, hepatic, renal, neurological and psychiatric disorders, as determined by clinical evaluation or pre-existing laboratory screening tests.
• Acute disease and/or fever at the time of enrolment.

• Fever is defined as temperature >=37.5°C on oral setting.
• Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
• 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.
• Any medical conditions in which IM injections are contraindicated
• Pregnant or lactating female.
• 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

Güglingen, Baden-Wurttemberg, Germany

GSK Investigational Site

Mannheim, Baden-Wurttemberg, Germany

GSK Investigational Site

Rudersberg, Baden-Wurttemberg, Germany

GSK Investigational Site

Weinheim, Baden-Wurttemberg, Germany

GSK Investigational Site

Augsburg, Bavaria, Germany

GSK Investigational Site

Cologne, North Rhine-Westphalia, Germany

GSK Investigational Site

Essen, North Rhine-Westphalia, Germany

GSK Investigational Site

Mainz, Rhineland-Palatinate, Germany

GSK Investigational Site

Rhaunen, Rhineland-Palatinate, Germany

GSK Investigational Site

Dresden, Saxony, Germany

GSK Investigational Site

Freital, Saxony, Germany

GSK Investigational Site

Leipzig, Saxony, Germany

GSK Investigational Site

Magdeburg, Saxony-Anhalt, Germany

GSK Investigational Site

Wolmirstedt, Saxony-Anhalt, Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Hamburg, , Germany

GSK Investigational Site

Hamburg, , Germany

GSK Investigational Site

Rotterdam, , Netherlands

GSK Investigational Site

Rotterdam, , Netherlands

GSK Investigational Site

Eskilstuna, , Sweden

GSK Investigational Site

Karlskrona, , Sweden

GSK Investigational Site

Uppsala, , Sweden

Countries

Germany; Netherlands; Sweden

Study Documents

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

Document Type: Individual Participant Data Set

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: Dataset Specification

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

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

113094

Identifier Type: -

Identifier Source: org_study_id