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Trial to Evaluate the Efficacy of GSK Biologicals' Influenza Vaccine GSK2186877A in Adults 65 Year of Age and Older

Primary Purpose

Influenza

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

GSK Bio's influenza vaccine GSK2186877A

Fluarix TM

About this trial

This is an interventional prevention trial for Influenza focused on measuring Efficacy, Influenza Vaccines, Influenza, Vaccine, Elderly

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
A man or woman aged 65 years or older at the time of the vaccination.
Written informed consent obtained from the subject.
Subjects with residence status allowing free mixing with general community.

Exclusion Criteria:

Bedridden subjects
Previous vaccination against influenza since February 2008.
Previous vaccination in the last three years with an investigational adjuvanted candidate seasonal or pandemic influenza vaccine.
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Any contra-indication to intramuscular administration of the influenza vaccines.
History of hypersensitivity to a previous dose of influenza vaccine.
History of allergy or reactions likely to be exacerbated by any component of the vaccine including egg and chicken protein.
Acute disease at the time of enrolment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature <37.5°C (99.5°F).

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

FluNG Group

Fluarix Group

Arm Description

subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).

subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).

Outcomes

Primary Outcome Measures

Number of Subjects Reporting Polymerase Chain Reaction (PCR)-Confirmed Influenza A and/or B Infection.

Occurrence of PCR-confirmed influenza A and/or B infection, due to any matching or drift influenza strain relative to the vaccine strains (i.e. not emerging novel human influenza strain like H1N1v). PCR-confirmed influenza (PCI) was defined as an episode of influenza-like illness (ILI) occurring after the administration of the study vaccine for which a nasal and throat swab specimen yields influenza virus A and/or B by reverse transcription polymerase chain reaction (RT-PCR) analysis.

Serum Hemagglutination-inhibition (HI) Antibody Titers, Against Each of the 3 Vaccine Influenza Strains, in the FluNG Groups.

Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Titers were expressed as geometric mean titers calculated on all subjects in the lot-to-lot subset of subjects.

Secondary Outcome Measures

Number of Subjects Reporting Polymerase Chain Reaction (PCR)-Confirmed Influenza A and/or B Infection.

Number of Subjects Reporting Culture-confirmed Influenza A and/or B Infection.

Occurrence of culture-confirmed influenza A and/or B infection, due to any matching or drift influenza strain relative to the vaccine strains (i.e. not emerging novel human influenza strain like H1N1v). Culture-confirmed influenza (CCI) was defined as an episode of ILI occurring after the administration of the study vaccine for which a nasal and throat swab specimen yields influenza virus A and/or B by viral culture analysis.

Number of Subjects Reporting Pneumonia or Clinical Influenza After the First Dose of Vaccine.

Clinical influenza= An ILI episode (with an ILI onset from the 15th of November until the end of the surveillance period) with at least simultaneously fever (oral temperature of ≥37.8 degrees Celsius) and cough. The influenza peak season = period during the study with the highest incidence of any matching or drift influenza strain relative to the vaccine strains (i.e. not emerging novel human influenza strain like H1N1v).

Number of Subjects Reporting All-cause Death After the First Dose of Vaccine.

The influenza peak season = period during the study with the highest incidence of any matching or drift influenza strain relative to the vaccine strains (i.e. not emerging novel human influenza strain like H1N1v).

Number of Subjects Reporting Hospitalization Due to Respiratory Diseases After the First Dose of Vaccine

Respiratory disease: A diagnosis of respiratory disease included: acute respiratory infections, other diseases of upper respiratory tract, pneumonia and influenza, chronic obstructive pulmonary disease and allied conditions, pneumoconioses and other lung diseases due to external agents, other diseases of respiratory system. In case the event has a fatal outcome, the diagnosis can also be confirmed by autopsy.

Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID).

Adverse events of specific interest for safety monitoring are a subset of AEs that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Grade 3 = event that prevented normal everyday activities Related = event assessed by the investigator as causally related to the study vaccination

Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID).

Number of Subjects Reporting Any and Related to Vaccination Serious Adverse Events (SAEs).

SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Related = event assessed by the investigator as causally related to the study vaccination

Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Symptoms.

Solicited local symptoms assessed were ecchymosis, pain, redness and swelling. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = considerable pain at rest that prevented normal everyday activities. Grade 3 ecchymosis/redness/swelling = ecchymosis/redness/swelling above 100 millimeter

Number of Days With Any Grade of Solicited Local Symptoms

Solicited local symptoms assessed were ecchymosis, pain, redness and swelling

Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Symptoms

Number of Days With Any Grade of Solicited Local Symptoms.

Solicited local symptoms assessed were ecchymosis, pain, redness and swelling.

Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Symptoms

Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and temperature (defined as oral temperature equal to or above (≥) 38.0 degrees Celsius). Any = incidence of a particular symptom regardless of intensity grade or relationship to vaccination. Grade 3 = general symptom which prevented normal everyday activities. Related = general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 temperature = oral temperature ≥39.0°C - ≤ 40.0°C.

Number of Days With Any Grade of Solicited General Symptoms

Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and temperature.

Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms.

Number of Days With Any Grade of Solicited General Symptoms.

Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and temperature.

Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs).

An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Grade 3 = event that prevented normal, everyday activities. Related = event assessed by the investigator as causally related to the study vaccination.

Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs).

Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited AEs With Medically Attended Visit

For each solicited and unsolicited symptom the subject experienced, the subjects were asked if they received medical attention defined as hospitalisation, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Grade 3 = event that prevented normal everyday activities. Related = event assessed by the investigator as causally related to the study vaccination.

Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited AEs With Medically Attended Visit.

Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains.

Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains

Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains.

Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Titers were expressed as geometric mean titers calculated on all subjects for 600 subjects in the persistence subset only.

Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains.

Number of Seroconverted Subjects for HI Antibodies Against Each of the 3 Vaccine Influenza Strains

In the lot-to-lot subset of subject in the FluGN Group. Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Seroconversion is defined as the number of subjects with pre-vaccination HI titer (Day 0) < 1:10 and post-vaccination titer (Day 21) ≥ 1:40 or a pre-vaccination HI titer (Day 0) ≥ 1:10 and fold-increase (post/pre) ≥ 4.

Full Information

NCT ID

NCT00753272

First Posted

September 12, 2008

Last Updated

May 8, 2018

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00753272

Brief Title

Trial to Evaluate the Efficacy of GSK Biologicals' Influenza Vaccine GSK2186877A in Adults 65 Year of Age and Older

Official Title

Observer-blind Superior Efficacy Trial With GlaxoSmithKline Biologicals' Influenza Vaccine GSK2186877A in Elderly Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

September 15, 2008 (Actual)

Primary Completion Date

June 18, 2010 (Actual)

Study Completion Date

January 5, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy of GlaxoSmithKline Biologicals' influenza vaccine GSK2186877A in adults 65 year of age and older. The study design is divided in two surveillance phases: one passive phase along the study during the influenza season and one active surveillance phase during the influenza peak season.

Detailed Description

This Protocol Posting has been updated according to Protocol Amendment 3, Sep 2009. After the analyses for this study were completed, questions arose regarding the integrity of study data from a single study site in Romania, which enrolled 102 subjects in the trial. Because evaluation of data from this site did not reveal irregularities when compared with overall study data and because GSK has no current plans to use the data from the study in support of any regulatory filings, they were not excluded from the analyses reflected in this results summary.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza

Keywords

Efficacy, Influenza Vaccines, Influenza, Vaccine, Elderly

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

43695 (Actual)

8. Arms, Groups, and Interventions

Arm Title

FluNG Group

Arm Type

Experimental

Arm Description

Arm Title

Fluarix Group

Arm Type

Active Comparator

Arm Description

Intervention Type

Biological

Intervention Name(s)

GSK Bio's influenza vaccine GSK2186877A

Intervention Description

IM administration, two times one annual dose, 3 different lots will be tested

Intervention Type

Biological

Intervention Name(s)

Fluarix TM

Intervention Description

IM administration, two times one annual dose

Primary Outcome Measure Information:

Title

Number of Subjects Reporting Polymerase Chain Reaction (PCR)-Confirmed Influenza A and/or B Infection.

Description

Time Frame

After the first dose during the corresponding surveillance period (from mid November 2008 to the end of April 2009 (end of influenza season))

Title

Serum Hemagglutination-inhibition (HI) Antibody Titers, Against Each of the 3 Vaccine Influenza Strains, in the FluNG Groups.

Description

Time Frame

At Days 0 (pre-vaccination Dose 1) and 21 (post-vaccination Dose 1) of the first year (2008/2009) of the study

Secondary Outcome Measure Information:

Title

Number of Subjects Reporting Polymerase Chain Reaction (PCR)-Confirmed Influenza A and/or B Infection.

Description

Time Frame

During the whole surveillance period (from mid November 2008 to end of April 2009 and from mid November 2009 to end of April 2010)

Title

Number of Subjects Reporting Culture-confirmed Influenza A and/or B Infection.

Description

Time Frame

During the whole surveillance period (from mid November 2008 to end of April 2009 and from mid November 2009 to end of April 2010)

Title

Number of Subjects Reporting Pneumonia or Clinical Influenza After the First Dose of Vaccine.

Description

Time Frame

During the influenza peak season within the first surveillance period (the influenza peak season being defined per country, falling somewhere between mid November 2008 to end of April 2009)

Title

Number of Subjects Reporting All-cause Death After the First Dose of Vaccine.

Description

Time Frame

During the influenza peak season within the first surveillance period (the influenza peak season being defined per country, falling somewhere between mid November 2008 to end of April 2009)

Title

Number of Subjects Reporting Hospitalization Due to Respiratory Diseases After the First Dose of Vaccine

Description

Time Frame

During the influenza peak season within the first surveillance period (the influenza peak season being defined per country, falling somewhere between mid November 2008 to end of April 2009)

Title

Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID).

Description

Time Frame

Within 365 days after the first dose (from Dose 1 at Day 0 up to Day 365 for the Year 2008/2009)

Title

Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID).

Description

Time Frame

Within 365 days after the second dose (from Dose 1 at Day 0 up to Day 365 for the Year 2009/2010)

Title

Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID).

Description

Time Frame

During the entire study period (during the 365 days of follow-up after each vaccination at Year 2008/2009 and Year 2009/2010)

Title

Number of Subjects Reporting Any and Related to Vaccination Serious Adverse Events (SAEs).

Description

Time Frame

During the entire study period (during the 365 days of follow-up after each vaccination at Year 2008/2009 and Year 2009/2010)

Title

Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Symptoms.

Description

Time Frame

During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009)

Title

Number of Days With Any Grade of Solicited Local Symptoms

Description

Solicited local symptoms assessed were ecchymosis, pain, redness and swelling

Time Frame

During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009)

Title

Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Symptoms

Description

Time Frame

During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010)

Title

Number of Days With Any Grade of Solicited Local Symptoms.

Description

Solicited local symptoms assessed were ecchymosis, pain, redness and swelling.

Time Frame

During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010)

Title

Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Symptoms

Description

Time Frame

During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009)

Title

Number of Days With Any Grade of Solicited General Symptoms

Description

Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and temperature.

Time Frame

During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009)

Title

Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms.

Description

Time Frame

During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010)

Title

Number of Days With Any Grade of Solicited General Symptoms.

Description

Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and temperature.

Time Frame

During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010)

Title

Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs).

Description

Time Frame

Within 21 days (Days 0-20) after the first dose (Year 2008/2009)

Title

Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs).

Description

Time Frame

Within 21 days (Days 0-20) after the second dose (Year 2009/2010)

Title

Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited AEs With Medically Attended Visit

Description

Time Frame

Within 180 days (Days 0-179) after the first dose (Year 2008/2009)

Title

Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited AEs With Medically Attended Visit.

Description

Time Frame

Within 180 days (Days 0-179) after the second dose (Year 2009/2010)

Title

Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains.

Description

Time Frame

At Days 0 (pre-vaccination Dose 1) and 21 (post-vaccination Dose 1) of the first year (2008/2009) of the study

Title

Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains

Description

Time Frame

At Days 0 (pre-vaccination Dose 2) and 21 (post-vaccination Dose 2) of the second year (2009/2010) of the study

Title

Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains.

Description

Time Frame

At Days 0 (pre-vaccination Dose 1), 21 (post-vaccination Dose 1) and 180 (post-vaccination Dose 1) of the first year (2008/2009) of the study

Title

Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains.

Description

Time Frame

At Days 0 (pre-vaccination Dose 2), 21 (post-vaccination Dose 2) and 180 (post-vaccination Dose 2) of the second year (2009/2010) of the study

Title

Number of Seroconverted Subjects for HI Antibodies Against Each of the 3 Vaccine Influenza Strains

Description

Time Frame

At Day 21 of the first year (2008/2009) of the study.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects who the investigator believes that they can and will comply with the requirements of the protocol. A man or woman aged 65 years or older at the time of the vaccination. Written informed consent obtained from the subject. Subjects with residence status allowing free mixing with general community. Exclusion Criteria: Bedridden subjects Previous vaccination against influenza since February 2008. Previous vaccination in the last three years with an investigational adjuvanted candidate seasonal or pandemic influenza vaccine. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. Any contra-indication to intramuscular administration of the influenza vaccines. History of hypersensitivity to a previous dose of influenza vaccine. History of allergy or reactions likely to be exacerbated by any component of the vaccine including egg and chicken protein. Acute disease at the time of enrolment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature <37.5°C (99.5°F).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Alabaster

State/Province

Alabama

ZIP/Postal Code

35007

Country

United States

Facility Name

GSK Investigational Site

City

Huntsville

State/Province

Alabama

ZIP/Postal Code

35802

Country

United States

Facility Name

GSK Investigational Site

City

Mobile

State/Province

Alabama

ZIP/Postal Code

36608

Country

United States

Facility Name

GSK Investigational Site

City

Chandler

State/Province

Arizona

ZIP/Postal Code

85224

Country

United States

Facility Name

GSK Investigational Site

City

Mesa

State/Province

Arizona

ZIP/Postal Code

85203

Country

United States

Facility Name

GSK Investigational Site

City

Mesa

State/Province

Arizona

ZIP/Postal Code

85213

Country

United States

Facility Name

GSK Investigational Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85020

Country

United States

Facility Name

GSK Investigational Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85028

Country

United States

Facility Name

GSK Investigational Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85050

Country

United States

Facility Name

GSK Investigational Site

City

Tempe

State/Province

Arizona

ZIP/Postal Code

85283

Country

United States

Facility Name

GSK Investigational Site

City

Hot Springs

State/Province

Arkansas

ZIP/Postal Code

71901

Country

United States

Facility Name

GSK Investigational Site

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

GSK Investigational Site

City

Anaheim

State/Province

California

ZIP/Postal Code

92801

Country

United States

Facility Name

GSK Investigational Site

City

Santa Ana

State/Province

California

ZIP/Postal Code

92705

Country

United States

Facility Name

GSK Investigational Site

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33761

Country

United States

Facility Name

GSK Investigational Site

City

Coral Gables

State/Province

Florida

ZIP/Postal Code

33134

Country

United States

Facility Name

GSK Investigational Site

City

Crystal River

State/Province

Florida

ZIP/Postal Code

34429

Country

United States

Facility Name

GSK Investigational Site

City

Delray Beach

State/Province

Florida

ZIP/Postal Code

33484

Country

United States

Facility Name

GSK Investigational Site

City

Inverness

State/Province

Florida

ZIP/Postal Code

34452

Country

United States

Facility Name

GSK Investigational Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32205

Country

United States

Facility Name

GSK Investigational Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32216

Country

United States

Facility Name

GSK Investigational Site

City

Pembroke Pines

State/Province

Florida

ZIP/Postal Code

33024

Country

United States

Facility Name

GSK Investigational Site

City

Boise

State/Province

Idaho

ZIP/Postal Code

83642

Country

United States

Facility Name

GSK Investigational Site

City

Peoria

State/Province

Illinois

ZIP/Postal Code

61602

Country

United States

Facility Name

GSK Investigational Site

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66212

Country

United States

Facility Name

GSK Investigational Site

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67207

Country

United States

Facility Name

GSK Investigational Site

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64114

Country

United States

Facility Name

GSK Investigational Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63104

Country

United States

Facility Name

GSK Investigational Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

GSK Investigational Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68134

Country

United States

Facility Name

GSK Investigational Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89104

Country

United States

Facility Name

GSK Investigational Site

City

Hackensack

State/Province

New Jersey

ZIP/Postal Code

07601

Country

United States

Facility Name

GSK Investigational Site

City

Somers Point

State/Province

New Jersey

ZIP/Postal Code

08244

Country

United States

Facility Name

GSK Investigational Site

City

Camillus

State/Province

New York

ZIP/Postal Code

13031

Country

United States

Facility Name

GSK Investigational Site

City

Endwell

State/Province

New York

ZIP/Postal Code

13760

Country

United States

Facility Name

GSK Investigational Site

City

Johnson City

State/Province

New York

ZIP/Postal Code

13790

Country

United States

Facility Name

GSK Investigational Site

City

Rochester

State/Province

New York

ZIP/Postal Code

14621

Country

United States

Facility Name

GSK Investigational Site

City

Cary

State/Province

North Carolina

ZIP/Postal Code

27518

Country

United States

Facility Name

GSK Investigational Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28209

Country

United States

Facility Name

GSK Investigational Site

City

Hickory

State/Province

North Carolina

ZIP/Postal Code

28601

Country

United States

Facility Name

GSK Investigational Site

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27609

Country

United States

Facility Name

GSK Investigational Site

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27612

Country

United States

Facility Name

GSK Investigational Site

City

Salisbury

State/Province

North Carolina

ZIP/Postal Code

28144

Country

United States

Facility Name

GSK Investigational Site

City

Tabor City

State/Province

North Carolina

ZIP/Postal Code

28463

Country

United States

Facility Name

GSK Investigational Site

City

Carnegie

State/Province

Pennsylvania

ZIP/Postal Code

15106

Country

United States

Facility Name

GSK Investigational Site

City

Erie

State/Province

Pennsylvania

ZIP/Postal Code

16506

Country

United States

Facility Name

GSK Investigational Site

City

Grove City

State/Province

Pennsylvania

ZIP/Postal Code

16127

Country

United States

Facility Name

GSK Investigational Site

City

Jefferson Hills

State/Province

Pennsylvania

ZIP/Postal Code

15025

Country

United States

Facility Name

GSK Investigational Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19102

Country

United States

Facility Name

GSK Investigational Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15205

Country

United States

Facility Name

GSK Investigational Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15236

Country

United States

Facility Name

GSK Investigational Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15241

Country

United States

Facility Name

GSK Investigational Site

City

Uniontown

State/Province

Pennsylvania

ZIP/Postal Code

15401

Country

United States

Facility Name

GSK Investigational Site

City

Upper Saint Clair

State/Province

Pennsylvania

ZIP/Postal Code

15241

Country

United States

Facility Name

GSK Investigational Site

City

Warwick

State/Province

Rhode Island

ZIP/Postal Code

02886

Country

United States

Facility Name

GSK Investigational Site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29412

Country

United States

Facility Name

GSK Investigational Site

City

North Myrtle Beach

State/Province

South Carolina

ZIP/Postal Code

29582

Country

United States

Facility Name

GSK Investigational Site

City

Spartanburg

State/Province

South Carolina

ZIP/Postal Code

29303

Country

United States

Facility Name

GSK Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

GSK Investigational Site

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84109

Country

United States

Facility Name

GSK Investigational Site

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84121

Country

United States

Facility Name

GSK Investigational Site

City

West Jordan

State/Province

Utah

ZIP/Postal Code

84088

Country

United States

Facility Name

GSK Investigational Site

City

Marshfield

State/Province

Wisconsin

ZIP/Postal Code

54449

Country

United States

Facility Name

GSK Investigational Site

City

Anthée

ZIP/Postal Code

5520

Country

Belgium

Facility Name

GSK Investigational Site

City

Deinze

ZIP/Postal Code

9800

Country

Belgium

Facility Name

GSK Investigational Site

City

Dour

ZIP/Postal Code

7370

Country

Belgium

Facility Name

GSK Investigational Site

City

Drongen

ZIP/Postal Code

9031

Country

Belgium

Facility Name

GSK Investigational Site

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

GSK Investigational Site

City

Gozée

ZIP/Postal Code

6534

Country

Belgium

Facility Name

GSK Investigational Site

City

Hamois (Natoye)

ZIP/Postal Code

5360

Country

Belgium

Facility Name

GSK Investigational Site

City

Kerksken

ZIP/Postal Code

9451

Country

Belgium

Facility Name

GSK Investigational Site

City

Libramont

ZIP/Postal Code

6800

Country

Belgium

Facility Name

GSK Investigational Site

City

Linkebeek

ZIP/Postal Code

1630

Country

Belgium

Facility Name

GSK Investigational Site

City

Maldegem

ZIP/Postal Code

9990

Country

Belgium

Facility Name

GSK Investigational Site

City

Melsbroek

ZIP/Postal Code

1820

Country

Belgium

Facility Name

GSK Investigational Site

City

Merelbeke

ZIP/Postal Code

9820

Country

Belgium

Facility Name

GSK Investigational Site

City

Mettet

ZIP/Postal Code

5640

Country

Belgium

Facility Name

GSK Investigational Site

City

Oostakker

ZIP/Postal Code

9041

Country

Belgium

Facility Name

GSK Investigational Site

City

Waarschoot

ZIP/Postal Code

9950

Country

Belgium

Facility Name

GSK Investigational Site

City

Coquitlam

State/Province

British Columbia

ZIP/Postal Code

V3K 3P4

Country

Canada

Facility Name

GSK Investigational Site

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 1M9

Country

Canada

Facility Name

GSK Investigational Site

City

Bay Roberts

State/Province

Newfoundland and Labrador

ZIP/Postal Code

A0A 1G0

Country

Canada

Facility Name

GSK Investigational Site

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3K 6R8

Country

Canada

Facility Name

GSK Investigational Site

City

Truro

State/Province

Nova Scotia

ZIP/Postal Code

B2N 1L2

Country

Canada

Facility Name

GSK Investigational Site

City

Brampton

State/Province

Ontario

ZIP/Postal Code

L6T 3T1

Country

Canada

Facility Name

GSK Investigational Site

City

Sudbury

State/Province

Ontario

ZIP/Postal Code

P3E 1H5

Country

Canada

Facility Name

GSK Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M9W 4L6

Country

Canada

Facility Name

GSK Investigational Site

City

Gatineau

State/Province

Quebec

ZIP/Postal Code

J8Y 6S8

Country

Canada

Facility Name

GSK Investigational Site

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1H 4J6

Country

Canada

Facility Name

GSK Investigational Site

City

St-Romulad

State/Province

Quebec

ZIP/Postal Code

G6W 5M6

Country

Canada

Facility Name

GSK Investigational Site

City

Quebec

ZIP/Postal Code

G1W 4R4

Country

Canada

Facility Name

GSK Investigational Site

City

Hradec Kralove

ZIP/Postal Code

500 03

Country

Czechia

Facility Name

GSK Investigational Site

City

Jaroměř

ZIP/Postal Code

551 02

Country

Czechia

Facility Name

GSK Investigational Site

City

Jaroměř

Country

Czechia

Facility Name

GSK Investigational Site

City

Pardubice

ZIP/Postal Code

530 02

Country

Czechia

Facility Name

GSK Investigational Site

City

Pardubice

ZIP/Postal Code

530 12

Country

Czechia

Facility Name

GSK Investigational Site

City

Pardubice

Country

Czechia

Facility Name

GSK Investigational Site

City

Saku

ZIP/Postal Code

75501

Country

Estonia

Facility Name

GSK Investigational Site

City

Tallinn

ZIP/Postal Code

10117

Country

Estonia

Facility Name

GSK Investigational Site

City

Tallinn

ZIP/Postal Code

10617

Country

Estonia

Facility Name

GSK Investigational Site

City

Tallinn

ZIP/Postal Code

13419

Country

Estonia

Facility Name

GSK Investigational Site

City

Tallinn

ZIP/Postal Code

13619

Country

Estonia

Facility Name

GSK Investigational Site

City

Tartu

ZIP/Postal Code

50106

Country

Estonia

Facility Name

GSK Investigational Site

City

Tartu

ZIP/Postal Code

50410

Country

Estonia

Facility Name

GSK Investigational Site

City

Angers

ZIP/Postal Code

49000

Country

France

Facility Name

GSK Investigational Site

City

Angers

ZIP/Postal Code

49100

Country

France

Facility Name

GSK Investigational Site

City

Anzin

ZIP/Postal Code

59410

Country

France

Facility Name

GSK Investigational Site

City

Arras

ZIP/Postal Code

62000

Country

France

Facility Name

GSK Investigational Site

City

Bordeaux

ZIP/Postal Code

33200

Country

France

Facility Name

GSK Investigational Site

City

Bécon les Granits

ZIP/Postal Code

49370

Country

France

Facility Name

GSK Investigational Site

City

Cannes

ZIP/Postal Code

06400

Country

France

Facility Name

GSK Investigational Site

City

Chambery

ZIP/Postal Code

73000

Country

France

Facility Name

GSK Investigational Site

City

Château Gontier

ZIP/Postal Code

53200

Country

France

Facility Name

GSK Investigational Site

City

Clermont-Ferrand

ZIP/Postal Code

63003

Country

France

Facility Name

GSK Investigational Site

City

Ecouflant

ZIP/Postal Code

49000

Country

France

Facility Name

GSK Investigational Site

City

Gresy sur Aix

ZIP/Postal Code

73100

Country

France

Facility Name

GSK Investigational Site

City

La Rochelle

ZIP/Postal Code

17000

Country

France

Facility Name

GSK Investigational Site

City

Laval

ZIP/Postal Code

53000

Country

France

Facility Name

GSK Investigational Site

City

Le Fousseret

ZIP/Postal Code

31430

Country

France

Facility Name

GSK Investigational Site

City

Montpellier Cedex 5

ZIP/Postal Code

34295

Country

France

Facility Name

GSK Investigational Site

City

Montreuil Juigne

ZIP/Postal Code

49460

Country

France

Facility Name

GSK Investigational Site

City

Muret

ZIP/Postal Code

31600

Country

France

Facility Name

GSK Investigational Site

City

Nieul sur Mer

ZIP/Postal Code

17137

Country

France

Facility Name

GSK Investigational Site

City

Oignies

ZIP/Postal Code

62590

Country

France

Facility Name

GSK Investigational Site

City

Orthez

ZIP/Postal Code

64300

Country

France

Facility Name

GSK Investigational Site

City

Paris Cedex 18

ZIP/Postal Code

75877

Country

France

Facility Name

GSK Investigational Site

City

Paris

ZIP/Postal Code

75679

Country

France

Facility Name

GSK Investigational Site

City

Rosiers d'Egletons

ZIP/Postal Code

19300

Country

France

Facility Name

GSK Investigational Site

City

Saint Etienne

ZIP/Postal Code

42100

Country

France

Facility Name

GSK Investigational Site

City

Segré

ZIP/Postal Code

49500

Country

France

Facility Name

GSK Investigational Site

City

Seysses

ZIP/Postal Code

31600

Country

France

Facility Name

GSK Investigational Site

City

Tierce

ZIP/Postal Code

49125

Country

France

Facility Name

GSK Investigational Site

City

Tours

ZIP/Postal Code

37100

Country

France

Facility Name

GSK Investigational Site

City

Vourey

ZIP/Postal Code

38210

Country

France

Facility Name

GSK Investigational Site

City

Gueglingen

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

74363

Country

Germany

Facility Name

GSK Investigational Site

City

Mannheim

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

68161

Country

Germany

Facility Name

GSK Investigational Site

City

Messkirch

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

88605

Country

Germany

Facility Name

GSK Investigational Site

City

Rudersberg

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

73635

Country

Germany

Facility Name

GSK Investigational Site

City

Schwetzingen

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

68723

Country

Germany

Facility Name

GSK Investigational Site

City

Sinsheim

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

74889

Country

Germany

Facility Name

GSK Investigational Site

City

Tuebingen

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

72074

Country

Germany

Facility Name

GSK Investigational Site

City

Weinheim

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

69469

Country

Germany

Facility Name

GSK Investigational Site

City

Augsburg

State/Province

Bayern

ZIP/Postal Code

86150

Country

Germany

Facility Name

GSK Investigational Site

City

Haag

State/Province

Bayern

ZIP/Postal Code

83527

Country

Germany

Facility Name

GSK Investigational Site

City

Hoehenkirchen-Siegertsbrunn

State/Province

Bayern

ZIP/Postal Code

85635

Country

Germany

Facility Name

GSK Investigational Site

City

Kuenzing

State/Province

Bayern

ZIP/Postal Code

94550

Country

Germany

Facility Name

GSK Investigational Site

City

Muenchen

State/Province

Bayern

ZIP/Postal Code

80339

Country

Germany

Facility Name

GSK Investigational Site

City

Muenchen

State/Province

Bayern

ZIP/Postal Code

80636

Country

Germany

Facility Name

GSK Investigational Site

City

Rednitzhembach

State/Province

Bayern

ZIP/Postal Code

91126

Country

Germany

Facility Name

GSK Investigational Site

City

Wuerzburg

State/Province

Bayern

ZIP/Postal Code

97070

Country

Germany

Facility Name

GSK Investigational Site

City

Cottbus

State/Province

Brandenburg

ZIP/Postal Code

03050

Country

Germany

Facility Name

GSK Investigational Site

City

Ketzin

State/Province

Brandenburg

ZIP/Postal Code

14669

Country

Germany

Facility Name

GSK Investigational Site

City

Ruedersdorf

State/Province

Brandenburg

ZIP/Postal Code

15562

Country

Germany

Facility Name

GSK Investigational Site

City

Bad Kreuznach

State/Province

Hessen

ZIP/Postal Code

55545

Country

Germany

Facility Name

GSK Investigational Site

City

Floersheim

State/Province

Hessen

ZIP/Postal Code

65439

Country

Germany

Facility Name

GSK Investigational Site

City

Rostock

State/Province

Mecklenburg-Vorpommern

ZIP/Postal Code

18057

Country

Germany

Facility Name

GSK Investigational Site

City

Schwerin

State/Province

Mecklenburg-Vorpommern

ZIP/Postal Code

19055

Country

Germany

Facility Name

GSK Investigational Site

City

Brinkum/Stuhr

State/Province

Niedersachsen

ZIP/Postal Code

28816

Country

Germany

Facility Name

GSK Investigational Site

City

Duelmen

State/Province

Niedersachsen

ZIP/Postal Code

48249

Country

Germany

Facility Name

GSK Investigational Site

City

Koenigslutter

State/Province

Niedersachsen

ZIP/Postal Code

38154

Country

Germany

Facility Name

GSK Investigational Site

City

Rotenburg (Wuemme)

State/Province

Niedersachsen

ZIP/Postal Code

27356

Country

Germany

Facility Name

GSK Investigational Site

City

Bochum

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

44787

Country

Germany

Facility Name

GSK Investigational Site

City

Essen

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

45359

Country

Germany

Facility Name

GSK Investigational Site

City

Goch

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

47574

Country

Germany

Facility Name

GSK Investigational Site

City

Koeln

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

51063

Country

Germany

Facility Name

GSK Investigational Site

City

Koeln

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

51069

Country

Germany

Facility Name

GSK Investigational Site

City

Muenster

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

48155

Country

Germany

Facility Name

GSK Investigational Site

City

Witten

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

58455

Country

Germany

Facility Name

GSK Investigational Site

City

Ingelheim

State/Province

Rheinland-Pfalz

ZIP/Postal Code

55218

Country

Germany

Facility Name

GSK Investigational Site

City

Kallstadt

State/Province

Rheinland-Pfalz

ZIP/Postal Code

67169

Country

Germany

Facility Name

GSK Investigational Site

City

Mainz

State/Province

Rheinland-Pfalz

ZIP/Postal Code

55116

Country

Germany

Facility Name

GSK Investigational Site

City

Mainz

State/Province

Rheinland-Pfalz

ZIP/Postal Code

55131

Country

Germany

Facility Name

GSK Investigational Site

City

Rhaunen

State/Province

Rheinland-Pfalz

ZIP/Postal Code

55624

Country

Germany

Facility Name

GSK Investigational Site

City

Koethen

State/Province

Sachsen-Anhalt

ZIP/Postal Code

06366

Country

Germany

Facility Name

GSK Investigational Site

City

Magdeburg

State/Province

Sachsen-Anhalt

ZIP/Postal Code

39104

Country

Germany

Facility Name

GSK Investigational Site

City

Magdeburg

State/Province

Sachsen-Anhalt

ZIP/Postal Code

39112

Country

Germany

Facility Name

GSK Investigational Site

City

Wolmirstedt

State/Province

Sachsen-Anhalt

ZIP/Postal Code

39326

Country

Germany

Facility Name

GSK Investigational Site

City

Borna

State/Province

Sachsen

ZIP/Postal Code

04552

Country

Germany

Facility Name

GSK Investigational Site

City

Delitzsch

State/Province

Sachsen

ZIP/Postal Code

04509

Country

Germany

Facility Name

GSK Investigational Site

City

Dresden

State/Province

Sachsen

ZIP/Postal Code

01069

Country

Germany

Facility Name

GSK Investigational Site

City

Dresden

State/Province

Sachsen

ZIP/Postal Code

01099

Country

Germany

Facility Name

GSK Investigational Site

City

Dresden

State/Province

Sachsen

ZIP/Postal Code

01307

Country

Germany

Facility Name

GSK Investigational Site

City

Freiberg

State/Province

Sachsen

ZIP/Postal Code

09599

Country

Germany

Facility Name

GSK Investigational Site

City

Freital

State/Province

Sachsen

ZIP/Postal Code

01705

Country

Germany

Facility Name

GSK Investigational Site

City

Geringswalde

State/Province

Sachsen

ZIP/Postal Code

09326

Country

Germany

Facility Name

GSK Investigational Site

City

Leipzig

State/Province

Sachsen

ZIP/Postal Code

04103

Country

Germany

Facility Name

GSK Investigational Site

City

Leipzig

State/Province

Sachsen

ZIP/Postal Code

04207

Country

Germany

Facility Name

GSK Investigational Site

City

Leipzig

State/Province

Sachsen

ZIP/Postal Code

04315

Country

Germany

Facility Name

GSK Investigational Site

City

Schmiedeberg

State/Province

Sachsen

ZIP/Postal Code

01762

Country

Germany

Facility Name

GSK Investigational Site

City

Weissenberg

State/Province

Sachsen

ZIP/Postal Code

02627

Country

Germany

Facility Name

GSK Investigational Site

City

Bad Bramstedt

State/Province

Schleswig-Holstein

ZIP/Postal Code

24576

Country

Germany

Facility Name

GSK Investigational Site

City

Bad Segeberg

State/Province

Schleswig-Holstein

ZIP/Postal Code

23795

Country

Germany

Facility Name

GSK Investigational Site

City

Luebeck

State/Province

Schleswig-Holstein

ZIP/Postal Code

23554

Country

Germany

Facility Name

GSK Investigational Site

City

Erfurt

State/Province

Thueringen

ZIP/Postal Code

99084

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

10365

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

10367

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

10435

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

10629

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

10717

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

10777

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

10787

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

12157

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

12627

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

13086

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

13125

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

13347

Country

Germany

Facility Name

GSK Investigational Site

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

GSK Investigational Site

City

Hamburg

ZIP/Postal Code

20253

Country

Germany

Facility Name

GSK Investigational Site

City

Hamburg

ZIP/Postal Code

22143

Country

Germany

Facility Name

GSK Investigational Site

City

Hamburg

ZIP/Postal Code

22335

Country

Germany

Facility Name

GSK Investigational Site

City

Hamburg

ZIP/Postal Code

22339

Country

Germany

Facility Name

GSK Investigational Site

City

Hamburg

ZIP/Postal Code

22415

Country

Germany

Facility Name

GSK Investigational Site

City

Hamburg

ZIP/Postal Code

22769

Country

Germany

Facility Name

GSK Investigational Site

City

Ecatepec de Morelos

State/Province

Estado De México

ZIP/Postal Code

55075

Country

Mexico

Facility Name

GSK Investigational Site

City

Cuernavaca

State/Province

Morelos

Country

Mexico

Facility Name

GSK Investigational Site

City

Monterrey

State/Province

Nuevo León

ZIP/Postal Code

64610

Country

Mexico

Facility Name

GSK Investigational Site

City

Mexico

ZIP/Postal Code

14000

Country

Mexico

Facility Name

GSK Investigational Site

City

Rotterdam

ZIP/Postal Code

3001 DC

Country

Netherlands

Facility Name

GSK Investigational Site

City

Rotterdam

ZIP/Postal Code

3011 EN

Country

Netherlands

Facility Name

GSK Investigational Site

City

Soest

ZIP/Postal Code

3762 BN

Country

Netherlands

Facility Name

GSK Investigational Site

City

Utrecht

ZIP/Postal Code

3584 CX

Country

Netherlands

Facility Name

GSK Investigational Site

City

Alesund

Country

Norway

Facility Name

GSK Investigational Site

City

Bekkestua

ZIP/Postal Code

1319

Country

Norway

Facility Name

GSK Investigational Site

City

Bergen

ZIP/Postal Code

5094

Country

Norway

Facility Name

GSK Investigational Site

City

Elverum

ZIP/Postal Code

2408

Country

Norway

Facility Name

GSK Investigational Site

City

Hamar

ZIP/Postal Code

2317

Country

Norway

Facility Name

GSK Investigational Site

City

Oslo

ZIP/Postal Code

0277

Country

Norway

Facility Name

GSK Investigational Site

City

Oslo

ZIP/Postal Code

0484

Country

Norway

Facility Name

GSK Investigational Site

City

Skien

ZIP/Postal Code

3717

Country

Norway

Facility Name

GSK Investigational Site

City

Stavanger

ZIP/Postal Code

4005

Country

Norway

Facility Name

GSK Investigational Site

City

Bydgoszcz

ZIP/Postal Code

85-021

Country

Poland

Facility Name

GSK Investigational Site

City

Debica

ZIP/Postal Code

39-200

Country

Poland

Facility Name

GSK Investigational Site

City

Grodzisk Mazowiecki

ZIP/Postal Code

05-825

Country

Poland

Facility Name

GSK Investigational Site

City

Ilawa

ZIP/Postal Code

14-200

Country

Poland

Facility Name

GSK Investigational Site

City

Inowrocław

ZIP/Postal Code

88-100

Country

Poland

Facility Name

GSK Investigational Site

City

Katowice

ZIP/Postal Code

40-018

Country

Poland

Facility Name

GSK Investigational Site

City

Krakow

ZIP/Postal Code

30-695

Country

Poland

Facility Name

GSK Investigational Site

City

Krakow

ZIP/Postal Code

31-135

Country

Poland

Facility Name

GSK Investigational Site

City

Krakow

ZIP/Postal Code

31-305

Country

Poland

Facility Name

GSK Investigational Site

City

Lubartow

ZIP/Postal Code

21-100

Country

Poland

Facility Name

GSK Investigational Site

City

Olesnica

ZIP/Postal Code

56-400

Country

Poland

Facility Name

GSK Investigational Site

City

Plock

ZIP/Postal Code

09-400

Country

Poland

Facility Name

GSK Investigational Site

City

Porabka

ZIP/Postal Code

43-353

Country

Poland

Facility Name

GSK Investigational Site

City

Siemianowice Slaskie

ZIP/Postal Code

41-103

Country

Poland

Facility Name

GSK Investigational Site

City

Sopot

ZIP/Postal Code

81-741

Country

Poland

Facility Name

GSK Investigational Site

City

Torun

ZIP/Postal Code

87-100

Country

Poland

Facility Name

GSK Investigational Site

City

Trzebnica

ZIP/Postal Code

55-100

Country

Poland

Facility Name

GSK Investigational Site

City

Tychy

ZIP/Postal Code

43-100

Country

Poland

Facility Name

GSK Investigational Site

City

Wroclaw

ZIP/Postal Code

50-088

Country

Poland

Facility Name

GSK Investigational Site

City

Braila

ZIP/Postal Code

810019

Country

Romania

Facility Name

GSK Investigational Site

City

Braila

ZIP/Postal Code

810384

Country

Romania

Facility Name

GSK Investigational Site

City

Brasov

ZIP/Postal Code

500014

Country

Romania

Facility Name

GSK Investigational Site

City

Brasov

ZIP/Postal Code

500260

Country

Romania

Facility Name

GSK Investigational Site

City

Brasov

ZIP/Postal Code

500366

Country

Romania

Facility Name

GSK Investigational Site

City

Bucharest

ZIP/Postal Code

010194

Country

Romania

Facility Name

GSK Investigational Site

City

Bucharest

ZIP/Postal Code

020142

Country

Romania

Facility Name

GSK Investigational Site

City

Bucharest

ZIP/Postal Code

062289

Country

Romania

Facility Name

GSK Investigational Site

City

Bucharest

ZIP/Postal Code

077190

Country

Romania

Facility Name

GSK Investigational Site

City

Craiova

ZIP/Postal Code

200128

Country

Romania

Facility Name

GSK Investigational Site

City

Galati

ZIP/Postal Code

800338

Country

Romania

Facility Name

GSK Investigational Site

City

Galati

ZIP/Postal Code

800578

Country

Romania

Facility Name

GSK Investigational Site

City

Pantelimon

ZIP/Postal Code

77145

Country

Romania

Facility Name

GSK Investigational Site

City

Ploiesti

ZIP/Postal Code

100172

Country

Romania

Facility Name

GSK Investigational Site

City

Barnaul

ZIP/Postal Code

656056

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Ekaterinburg

ZIP/Postal Code

620137

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Ekaterinburg

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Perm

ZIP/Postal Code

614010

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Perm

ZIP/Postal Code

614087

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Taipei

ZIP/Postal Code

100

Country

Taiwan

Facility Name

GSK Investigational Site

City

Taipei

ZIP/Postal Code

112

Country

Taiwan

Facility Name

GSK Investigational Site

City

Reading

State/Province

Berkshire

ZIP/Postal Code

RG2 0TG

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Buckshaw Village, Chorley

State/Province

Lancashire

ZIP/Postal Code

PR7 7NA

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Liverpool

State/Province

Merseyside

ZIP/Postal Code

L22 0LG

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Waterloo, Liverpool

ZIP/Postal Code

L22 0LG

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Citations:

PubMed Identifier

27690762

Citation

Ruiz-Palacios GM, Leroux-Roels G, Beran J, Devaster JM, Esen M, Launay O, McElhaney JE, van Essen GA, Benoit A, Claeys C, Dewe W, Durand C, Duval X, Falsey AR, Feldman G, Galtier F, Gervais P, Hwang SJ, McNeil S, Richardus JH, Trofa A, Oostvogels L; Influence65 study group. Immunogenicity of AS03-adjuvanted and non-adjuvanted trivalent inactivated influenza vaccines in elderly adults: A Phase 3, randomized trial and post-hoc correlate of protection analysis. Hum Vaccin Immunother. 2016 Dec;12(12):3043-3055. doi: 10.1080/21645515.2016.1219809.

Results Reference

derived

PubMed Identifier

24702710

Citation

van Essen GA, Beran J, Devaster JM, Durand C, Duval X, Esen M, Falsey AR, Feldman G, Gervais P, Innis BL, Kovac M, Launay O, Leroux-Roels G, McElhaney JE, McNeil S, Oujaa M, Richardus JH, Ruiz-Palacios G, Osborne RH, Oostvogels L. Influenza symptoms and their impact on elderly adults: randomised trial of AS03-adjuvanted or non-adjuvanted inactivated trivalent seasonal influenza vaccines. Influenza Other Respir Viruses. 2014 Jul;8(4):452-62. doi: 10.1111/irv.12245. Epub 2014 Apr 4.

Results Reference

derived

PubMed Identifier

23518156

Citation

McElhaney JE, Beran J, Devaster JM, Esen M, Launay O, Leroux-Roels G, Ruiz-Palacios GM, van Essen GA, Caplanusi A, Claeys C, Durand C, Duval X, El Idrissi M, Falsey AR, Feldman G, Frey SE, Galtier F, Hwang SJ, Innis BL, Kovac M, Kremsner P, McNeil S, Nowakowski A, Richardus JH, Trofa A, Oostvogels L; Influence65 study group. AS03-adjuvanted versus non-adjuvanted inactivated trivalent influenza vaccine against seasonal influenza in elderly people: a phase 3 randomised trial. Lancet Infect Dis. 2013 Jun;13(6):485-96. doi: 10.1016/S1473-3099(13)70046-X. Epub 2013 Mar 19.

Results Reference

derived

Links:

URL

https://www.clinicalstudydatarequest.com

Description

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

Available IPD and Supporting Information:

Available IPD/Information Type

Annotated Case Report Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

106372

Available IPD/Information Comments

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

Available IPD/Information Type

Informed Consent Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

106372

Available IPD/Information Comments

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

Available IPD/Information Type

Statistical Analysis Plan

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

106372

Available IPD/Information Comments

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

Available IPD/Information Type

Clinical Study Report

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

106372

Available IPD/Information Comments

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

Available IPD/Information Type

Dataset Specification

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

106372

Available IPD/Information Comments

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

Available IPD/Information Type

Individual Participant Data Set

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

106372

Available IPD/Information Comments

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

Available IPD/Information Type

Study Protocol

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

106372

Available IPD/Information Comments

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

Learn more about this trial

Trial to Evaluate the Efficacy of GSK Biologicals' Influenza Vaccine GSK2186877A in Adults 65 Year of Age and Older

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Trial to Evaluate the Efficacy of GSK Biologicals' Influenza Vaccine GSK2186877A in Adults 65 Year of Age and Older

Influenza

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial