Safety and Immunogenicity Study of GSK Biologicals' Seasonal Influenza Candidate Vaccine (GSK2321138A)
Partially-blind Immunogenicity and Safety Study of GSK Biologicals' Seasonal Influenza Vaccine GSK2321138A in Adults.
1 other identifier
interventional
4,659
6 countries
42
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2010
Shorter than P25 for phase_3
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 16, 2010
CompletedFirst Posted
Study publicly available on registry
September 17, 2010
CompletedStudy Start
First participant enrolled
October 4, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 6, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 6, 2011
CompletedResults Posted
Study results publicly available
June 17, 2013
CompletedSeptember 24, 2018
February 1, 2017
8 months
September 16, 2010
December 13, 2012
August 22, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
At Day 0 (D 0), and at Day 21 (D 21)
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.
At Day 21 (D 21)
Secondary Outcomes (11)
Number of Seropositive Subjects Against 4 Strains of Influenza Disease
At Day 0 (D 0), and at Day 21 (D 21)
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease
At Day 0 (D 0), and at Day 21 (D 21)
Increase in Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease
At Day 21 (D 21)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Within the 7-day (Days 0-6) follow-up period after vaccination
Number of Days With Solicited Local Symptoms
Within the 7-day (Days 0-6) follow-up period after vaccination
- +6 more secondary outcomes
Study Arms (5)
GSK2321138A Lot 1 Group
EXPERIMENTALSubjects 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.
GSK2321138A Lot 2 Group
EXPERIMENTALSubjects 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.
GSK2321138A Lot 3 Group
EXPERIMENTALSubjects 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.
Fluarix Group
ACTIVE COMPARATORSubjects 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.
GSK2604409A Group
ACTIVE COMPARATORSubjects 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.
Interventions
One intramuscular injection
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (42)
GSK Investigational Site
Chandler, Arizona, 85224, United States
GSK Investigational Site
Miami, Florida, 33143, United States
GSK Investigational Site
Newton, Kansas, 67114, United States
GSK Investigational Site
Lexington, Kentucky, 40509, United States
GSK Investigational Site
Columbia, Maryland, 21045, United States
GSK Investigational Site
Milford, Massachusetts, 01757, United States
GSK Investigational Site
Las Vegas, Nevada, 89119, United States
GSK Investigational Site
Salisbury, North Carolina, 28144, United States
GSK Investigational Site
Erie, Pennsylvania, 16506, United States
GSK Investigational Site
Nashville, Tennessee, 37203, United States
GSK Investigational Site
Tübingen, Baden-Wurttemberg, 72074, Germany
GSK Investigational Site
Augsburg, Bavaria, 86150, Germany
GSK Investigational Site
Haag, Bavaria, 83527, Germany
GSK Investigational Site
Finsterwalde, Brandenburg, 03238, Germany
GSK Investigational Site
Frankfurt am Main, Hesse, 60596, Germany
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55131, Germany
GSK Investigational Site
Dresden, Saxony, 01277, Germany
GSK Investigational Site
Dresden, Saxony, 01307, Germany
GSK Investigational Site
Dresden, Saxony, 01309, Germany
GSK Investigational Site
Freiberg, Saxony, 09599, Germany
GSK Investigational Site
Berlin, 10367, Germany
GSK Investigational Site
Berlin, 13086, Germany
GSK Investigational Site
Brasov, 500260, Romania
GSK Investigational Site
Brăila, 810384, Romania
GSK Investigational Site
Bucharest, 020142, Romania
GSK Investigational Site
Bucharest, 062289, Romania
GSK Investigational Site
Bucharest, 077190, Romania
GSK Investigational Site
Galati, 800494, Romania
GSK Investigational Site
Galati, 800578, Romania
GSK Investigational Site
Pantelimon, 77145, Romania
GSK Investigational Site
Ploieşti, 100172, Romania
GSK Investigational Site
Guro Gu, 152703, South Korea
GSK Investigational Site
Gyeonggi-do, 442-723, South Korea
GSK Investigational Site
Incheon, 400-711, South Korea
GSK Investigational Site
Seoul, 150-719, South Korea
GSK Investigational Site
Balenyà (Barcelona), 08550, Spain
GSK Investigational Site
Barcelona, 08035, Spain
GSK Investigational Site
Centelles, Spain
GSK Investigational Site
La Roca Del Valles (Barcelona), 08430, Spain
GSK Investigational Site
Vic/ Barcelona, 08500, Spain
GSK Investigational Site
Taichung, 404, Taiwan
GSK Investigational Site
Taipei, Taiwan
Related Publications (1)
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.
PMID: 23883186DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Concerns arose about data integrity for a Romanian site (102 subjects) after completion of analysis. These data were not excluded from this reporting as they did not reveal irregularities and GSK does not plan to use them towards regulatory filing.
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2010
First Posted
September 17, 2010
Study Start
October 4, 2010
Primary Completion
June 6, 2011
Study Completion
June 6, 2011
Last Updated
September 24, 2018
Results First Posted
June 17, 2013
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.