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

NCT ID: NCT01204671

Last Updated: 2018-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 4659 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-04
• Study Completion Date: 2011-06-06

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.

Conditions

Influenza

Study Design

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

Study Groups

GSK2321138A Lot 1 Group

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.

Group Type: EXPERIMENTAL

Influenza vaccine GSK2321138A

Intervention Type: BIOLOGICAL

One intramuscular injection

GSK2321138A Lot 2 Group

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.

Group Type: EXPERIMENTAL

Influenza vaccine GSK2321138A

Intervention Type: BIOLOGICAL

One intramuscular injection

GSK2321138A Lot 3 Group

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.

Group Type: EXPERIMENTAL

Influenza vaccine GSK2321138A

Intervention Type: BIOLOGICAL

One intramuscular injection

Fluarix Group

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.

Group Type: ACTIVE_COMPARATOR

FluarixTM

Intervention Type: BIOLOGICAL

One intramuscular injection

GSK2604409A Group

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.

Group Type: ACTIVE_COMPARATOR

Influenza vaccine GSK2604409A

Intervention Type: BIOLOGICAL

One intramuscular injection

Interventions

Influenza vaccine GSK2321138A

One intramuscular injection

Intervention Type: BIOLOGICAL

FluarixTM

One intramuscular injection

Intervention Type: BIOLOGICAL

Influenza vaccine GSK2604409A

One intramuscular injection

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Chandler, Arizona, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Newton, Kansas, United States

GSK Investigational Site

Lexington, Kentucky, United States

GSK Investigational Site

Columbia, Maryland, United States

GSK Investigational Site

Milford, Massachusetts, United States

GSK Investigational Site

Las Vegas, Nevada, United States

GSK Investigational Site

Salisbury, North Carolina, United States

GSK Investigational Site

Erie, Pennsylvania, United States

GSK Investigational Site

Nashville, Tennessee, United States

GSK Investigational Site

Tübingen, Baden-Wurttemberg, Germany

GSK Investigational Site

Augsburg, Bavaria, Germany

GSK Investigational Site

Haag, Bavaria, Germany

GSK Investigational Site

Finsterwalde, Brandenburg, Germany

GSK Investigational Site

Frankfurt am Main, Hesse, Germany

GSK Investigational Site

Mainz, Rhineland-Palatinate, Germany

GSK Investigational Site

Dresden, Saxony, Germany

GSK Investigational Site

Dresden, Saxony, Germany

GSK Investigational Site

Dresden, Saxony, Germany

GSK Investigational Site

Freiberg, Saxony, Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Brasov, , Romania

GSK Investigational Site

Brăila, , Romania

GSK Investigational Site

Bucharest, , Romania

GSK Investigational Site

Bucharest, , Romania

GSK Investigational Site

Bucharest, , Romania

GSK Investigational Site

Galati, , Romania

GSK Investigational Site

Galati, , Romania

GSK Investigational Site

Pantelimon, , Romania

GSK Investigational Site

Ploieşti, , Romania

GSK Investigational Site

Guro Gu, , South Korea

GSK Investigational Site

Gyeonggi-do, , South Korea

GSK Investigational Site

Incheon, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Balenyà (Barcelona), , Spain

GSK Investigational Site

Barcelona, , Spain

GSK Investigational Site

Centelles, , Spain

GSK Investigational Site

La Roca Del Valles (Barcelona), , Spain

GSK Investigational Site

Vic/ Barcelona, , Spain

GSK Investigational Site

Taichung, , Taiwan

GSK Investigational Site

Taipei, , Taiwan

Countries

United States; Germany; Romania; South Korea; Spain; Taiwan

References

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.

Reference Type: DERIVED

PMID: 23883186 (View on PubMed)

Study Documents

Document Type: Individual Participant Data Set

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

View Document

Document Type: Statistical Analysis Plan

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

View Document

Document Type: Annotated Case Report Form

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

View Document

Document Type: Study Protocol

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: Clinical Study Report

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

114269

Identifier Type: -

Identifier Source: org_study_id