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Safety and Immunogenicity Study of GSK Biologicals' Seasonal Influenza Candidate Vaccine (GSK2321138A)

Primary Purpose

Influenza

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Influenza vaccine GSK2321138A

FluarixTM

Influenza vaccine GSK2604409A

About this trial

This is an interventional prevention trial for Influenza focused on measuring influenza infection, GSK Biologicals influenza vaccine GSK2321138A

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

A male or female 18 years of age or older at the time of the first vaccination
Subjects who the investigator believes can and will comply with the requirements of the protocol.
Written informed consent obtained from the subject.
Healthy subjects or those with chronic well-controlled disease as established by physical examination before entering into the study.
Female subjects of non-childbearing potential may be enrolled in the study.
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 urine pregnancy test on the day of vaccination,
and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series

Exclusion Criteria:

Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the dose of the study vaccine or planned use during the study period.
Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period.
Administration of an influenza vaccine during the 6 months preceding entry into the study.
Planned administration / administration of a vaccine not foreseen by the study protocol within 30 days before vaccination and up to Day 21.
Any contra-indication to intramuscular administration of the influenza vaccines.
History of hypersensitivity/anaphylaxis to a previous dose of influenza vaccine, history of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
Any administration of a long-acting immune-modifying drug within 3 months before study start, or planned administration during the study period.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
Acute disease and/or fever at the time of enrolment.
Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
History of Guillain-Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study.
History of chronic alcohol consumption and/or drug abuse.
Any condition which, in the opinion of the investigator, prevents the subject from participating in the study
Pregnant or lactating female.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Arm Label

GSK2321138A Lot 1 Group

GSK2321138A Lot 2 Group

GSK2321138A Lot 3 Group

Fluarix Group

GSK2604409A Group

Arm Description

Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.

Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.

Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.

Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.

Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.

Outcomes

Primary Outcome Measures

Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease

Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. HI antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.

Number of Seroconverted Subjects Against 4 Strains of Influenza Disease

A seroconverted subject was a vaccinated subject who had either a pre-vaccination hemagglutination inhibition (HI) antibody titer < 1:10 and a post-vaccination titer above or equal (>=) 1:40, or a pre-vaccination HI antibody titer >= 1:10 and at least a 4-fold increase in post-vaccination HI antibody titer. Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.

Secondary Outcome Measures

Number of Seropositive Subjects Against 4 Strains of Influenza Disease

A seropositive subject was a vaccinated subject with hemagglutination inhibition (HI) antibody titer above or equal (>=) the reference cut-off value of 1:10. Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.

Number of Seroprotected Subjects Against 4 Strains of Influenza Disease

A seroprotected subject was a vaccinated subject who had hemagglutination inhibition (HI) antibody titer above or equal (>=) 1:40. Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.

Increase in Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease

Increase in hemagglutination inhibition (HI) antibodies is presented in terms of mean geometric increase (MGI), defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer , expressed using "fold increase" as unit . Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.

Number of Subjects With Any and Grade 3 Solicited Local Symptoms.

Assessed solicited local symptoms post vaccination were pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity. Grade 3 pain = significant pain at rest/ that prevented normal every day activities. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.

Number of Days With Solicited Local Symptoms

Assessed solicited local symptoms post vaccination were pain, redness and swelling at the injection site.

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

Assessed solicited general symptoms post vaccination were fatigue, gastrointestinal symptoms (Gastr.), headache, joint pain at other location (Joint Pain), muscle aches, shivering, and temperature [axillary temperature above or equal to (>=) 37.5 degrees Celsius (°C)]. Any = occurrence of a symptom regardless of intensity or relationship to vaccination. Grade 3 = symptom which prevented normal every day activities. Grade 3 temperature = axillary temperature > 39°C. Related = symptom assessed as causally related to study vaccination.

Number of Days With Solicited General Symptoms

Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)

Unsolicited AEs cover any AE 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. Any unsolicited AE = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 unsolicited AE = unsolicited AE that prevented normal everyday activity Related unsolicited AE = unsolicited AE assessed by the investigator as related to the vaccination.

Number of Subjects With Any and Related Adverse Events With Medically-attended Events (MAEs)

Medically-attended events (MAEs) refer to non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. If a MAE was leading to hospitalisation (or met any other serious adverse event criterion), it was reported as serious adverse event. Related MAE = MAE assessed by the investigator as related to the vaccination. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.

Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs)

Potential immune-mediated diseases (pIMDs) are a subset of adverse events that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Related pIMD = pIMD assessed by the investigator as related to the vaccination. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.

Number of Subjects With Any and Related Serious Adverse Events (SAEs)

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE = any SAE regardless of intensity or relationship to vaccination. Related SAE = SAE assessed by the investigator as related to the vaccination.

Full Information

NCT ID

NCT01204671

First Posted

September 16, 2010

Last Updated

August 22, 2018

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT01204671

Brief Title

Safety and Immunogenicity Study of GSK Biologicals' Seasonal Influenza Candidate Vaccine (GSK2321138A)

Official Title

Partially-blind Immunogenicity and Safety Study of GSK Biologicals' Seasonal Influenza Vaccine GSK2321138A in Adults.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

October 4, 2010 (undefined)

Primary Completion Date

June 6, 2011 (Actual)

Study Completion Date

June 6, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary

This study is designed to assess the safety and immunogenicity of a GSK Biologicals' investigational vaccine GSK2321138A in adults 18 years old and older. This study is also designed to assess the lot-to-lot consistency of vaccine GSK2321138A. The blinding will be double blind for all groups except for the GSK2604409A Group which will be open.

6. Conditions and Keywords

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

Influenza

Keywords

influenza infection, GSK Biologicals influenza vaccine GSK2321138A

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

4659 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GSK2321138A Lot 1 Group

Arm Type

Experimental

Arm Description

Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.

Arm Title

GSK2321138A Lot 2 Group

Arm Type

Experimental

Arm Description

Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.

Arm Title

GSK2321138A Lot 3 Group

Arm Type

Experimental

Arm Description

Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.

Arm Title

Fluarix Group

Arm Type

Active Comparator

Arm Description

Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.

Arm Title

GSK2604409A Group

Arm Type

Active Comparator

Arm Description

Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.

Intervention Type

Biological

Intervention Name(s)

Influenza vaccine GSK2321138A

Intervention Description

One intramuscular injection

Intervention Type

Biological

Intervention Name(s)

FluarixTM

Intervention Description

One intramuscular injection

Intervention Type

Biological

Intervention Name(s)

Influenza vaccine GSK2604409A

Intervention Description

One intramuscular injection

Primary Outcome Measure Information:

Title

Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease

Description

Time Frame

At Day 0 (D 0), and at Day 21 (D 21)

Title

Number of Seroconverted Subjects Against 4 Strains of Influenza Disease

Description

Time Frame

At Day 21 (D 21)

Secondary Outcome Measure Information:

Title

Number of Seropositive Subjects Against 4 Strains of Influenza Disease

Description

Time Frame

At Day 0 (D 0), and at Day 21 (D 21)

Title

Number of Seroprotected Subjects Against 4 Strains of Influenza Disease

Description

Time Frame

At Day 0 (D 0), and at Day 21 (D 21)

Title

Increase in Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease

Description

Time Frame

At Day 21 (D 21)

Title

Number of Subjects With Any and Grade 3 Solicited Local Symptoms.

Description

Time Frame

Within the 7-day (Days 0-6) follow-up period after vaccination

Title

Number of Days With Solicited Local Symptoms

Description

Assessed solicited local symptoms post vaccination were pain, redness and swelling at the injection site.

Time Frame

Within the 7-day (Days 0-6) follow-up period after vaccination

Title

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

Description

Time Frame

Within the 7-day (Days 0-6) follow-up period after vaccination

Title

Number of Days With Solicited General Symptoms

Description

Time Frame

Within the 7-day (Days 0-6) follow-up period after vaccination

Title

Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)

Description

Time Frame

Within the 21-day (Days 0-20) follow-up period after vaccination

Title

Number of Subjects With Any and Related Adverse Events With Medically-attended Events (MAEs)

Description

Time Frame

From the beginning of the study (Day 0) to study end (Day 180)

Title

Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs)

Description

Time Frame

From the beginning of the study (Day 0) to study end (Day 180)

Title

Number of Subjects With Any and Related Serious Adverse Events (SAEs)

Description

Time Frame

From the beginning of the study (Day 0) to study end (Day 180)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: A male or female 18 years of age or older at the time of the first vaccination Subjects who the investigator believes can and will comply with the requirements of the protocol. Written informed consent obtained from the subject. Healthy subjects or those with chronic well-controlled disease as established by physical examination before entering into the study. Female subjects of non-childbearing potential may be enrolled in the study. 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 urine pregnancy test on the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series Exclusion Criteria: Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the dose of the study vaccine or planned use during the study period. Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period. Administration of an influenza vaccine during the 6 months preceding entry into the study. Planned administration / administration of a vaccine not foreseen by the study protocol within 30 days before vaccination and up to Day 21. Any contra-indication to intramuscular administration of the influenza vaccines. History of hypersensitivity/anaphylaxis to a previous dose of influenza vaccine, history of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines. Any administration of a long-acting immune-modifying drug within 3 months before study start, or planned administration during the study period. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. Acute disease and/or fever at the time of enrolment. Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. History of Guillain-Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine. Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study. History of chronic alcohol consumption and/or drug abuse. Any condition which, in the opinion of the investigator, prevents the subject from participating in the study Pregnant or lactating female.

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

Chandler

State/Province

Arizona

ZIP/Postal Code

85224

Country

United States

Facility Name

GSK Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33143

Country

United States

Facility Name

GSK Investigational Site

City

Newton

State/Province

Kansas

ZIP/Postal Code

67114

Country

United States

Facility Name

GSK Investigational Site

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40509

Country

United States

Facility Name

GSK Investigational Site

City

Columbia

State/Province

Maryland

ZIP/Postal Code

21045

Country

United States

Facility Name

GSK Investigational Site

City

Milford

State/Province

Massachusetts

ZIP/Postal Code

01757

Country

United States

Facility Name

GSK Investigational Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89119

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

Erie

State/Province

Pennsylvania

ZIP/Postal Code

16506

Country

United States

Facility Name

GSK Investigational Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

GSK Investigational Site

City

Tuebingen

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

72074

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

Finsterwalde

State/Province

Brandenburg

ZIP/Postal Code

03238

Country

Germany

Facility Name

GSK Investigational Site

City

Frankfurt am Main

State/Province

Hessen

ZIP/Postal Code

60596

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

Dresden

State/Province

Sachsen

ZIP/Postal Code

01277

Country

Germany

Facility Name

GSK Investigational Site

City

Dresden

State/Province

Sachsen

ZIP/Postal Code

01307

Country

Germany

Facility Name

GSK Investigational Site

City

Dresden

State/Province

Sachsen

ZIP/Postal Code

01309

Country

Germany

Facility Name

GSK Investigational Site

City

Freiberg

State/Province

Sachsen

ZIP/Postal Code

09599

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

13086

Country

Germany

Facility Name

GSK Investigational Site

City

Guro Gu

ZIP/Postal Code

152703

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Gyeonggi

ZIP/Postal Code

442-723

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Incheon

ZIP/Postal Code

400-711

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

150-719

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Braila

ZIP/Postal Code

810384

Country

Romania

Facility Name

GSK Investigational Site

City

Brasov

ZIP/Postal Code

500260

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

Galati

ZIP/Postal Code

800494

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

Balenyà (Barcelona)

ZIP/Postal Code

08550

Country

Spain

Facility Name

GSK Investigational Site

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

GSK Investigational Site

City

Centelles

Country

Spain

Facility Name

GSK Investigational Site

City

La Roca Del Valles (Barcelona)

ZIP/Postal Code

08430

Country

Spain

Facility Name

GSK Investigational Site

City

Vic/ Barcelona

ZIP/Postal Code

08500

Country

Spain

Facility Name

GSK Investigational Site

City

Taichung

ZIP/Postal Code

404

Country

Taiwan

Facility Name

GSK Investigational Site

City

Taipei

Country

Taiwan

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

23883186

Citation

Kieninger D, Sheldon E, Lin WY, Yu CJ, Bayas JM, Gabor JJ, Esen M, Fernandez Roure JL, Narejos Perez S, Alvarez Sanchez C, Feng Y, Claeys C, Peeters M, Innis BL, Jain V. Immunogenicity, reactogenicity and safety of an inactivated quadrivalent influenza vaccine candidate versus inactivated trivalent influenza vaccine: a phase III, randomized trial in adults aged >/=18 years. BMC Infect Dis. 2013 Jul 24;13:343. doi: 10.1186/1471-2334-13-343.

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

Individual Participant Data Set

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

114269

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

114269

Available IPD/Information Comments

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

Available IPD/Information Type

Annotated Case Report Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

114269

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

114269

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

114269

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

114269

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

114269

Available IPD/Information Comments

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

Learn more about this trial

Safety and Immunogenicity Study of GSK Biologicals' Seasonal Influenza Candidate Vaccine (GSK2321138A)

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Safety and Immunogenicity Study of GSK Biologicals' Seasonal Influenza Candidate Vaccine (GSK2321138A)

Influenza

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

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