Clinical trial NCT01204671: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: influenza infection
GSK Biologicals influenza vaccine GSK2321138A
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-09-17
Enrollment: 4659
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease
timeFrame: At Day 0 (D 0), and at Day 21 (D 21)
measure: Number of Seroconverted Subjects Against 4 Strains of Influenza Disease
timeFrame: At Day 21 (D 21)
Secondary outcomes:
measure: Number of Seropositive Subjects Against 4 Strains of Influenza Disease
timeFrame: At Day 0 (D 0), and at Day 21 (D 21)
measure: Number of Seroprotected Subjects Against 4 Strains of Influenza Disease
timeFrame: At Day 0 (D 0), and at Day 21 (D 21)
measure: Increase in Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease
timeFrame: At Day 21 (D 21)
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
timeFrame: Within the 7-day (Days 0-6) follow-up period after vaccination
measure: Number of Days With Solicited Local Symptoms
timeFrame: Within the 7-day (Days 0-6) follow-up period after vaccination
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
timeFrame: Within the 7-day (Days 0-6) follow-up period after vaccination
measure: Number of Days With Solicited General Symptoms
timeFrame: Within the 7-day (Days 0-6) follow-up period after vaccination
measure: Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
timeFrame: Within the 21-day (Days 0-20) follow-up period after vaccination
measure: Number of Subjects With Any and Related Adverse Events With Medically-attended Events (MAEs)
timeFrame: From the beginning of the study (Day 0) to study end (Day 180)
measure: Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs)
timeFrame: From the beginning of the study (Day 0) to study end (Day 180)
measure: Number of Subjects With Any and Related Serious Adverse Events (SAEs)
timeFrame: From the beginning of the study (Day 0) to study end (Day 180)
Other outcomes:
Locations:
city: Chandler
country: United States
facility: GSK Investigational Site
state: Arizona
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Newton
country: United States
facility: GSK Investigational Site
state: Kansas
city: Lexington
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Columbia
country: United States
facility: GSK Investigational Site
state: Maryland
city: Milford
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Las Vegas
country: United States
facility: GSK Investigational Site
state: Nevada
city: Salisbury
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Erie
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Nashville
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Tuebingen
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Augsburg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Haag
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Finsterwalde
country: Germany
facility: GSK Investigational Site
state: Brandenburg
city: Frankfurt am Main
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Mainz
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Freiberg
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Guro Gu
country: Korea, Republic of
facility: GSK Investigational Site
city: Gyeonggi
country: Korea, Republic of
facility: GSK Investigational Site
city: Incheon
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Braila
country: Romania
facility: GSK Investigational Site
city: Brasov
country: Romania
facility: GSK Investigational Site
city: Bucharest
country: Romania
facility: GSK Investigational Site
city: Bucharest
country: Romania
facility: GSK Investigational Site
city: Bucharest
country: Romania
facility: GSK Investigational Site
city: Galati
country: Romania
facility: GSK Investigational Site
city: Galati
country: Romania
facility: GSK Investigational Site
city: Pantelimon
country: Romania
facility: GSK Investigational Site
city: Ploiesti
country: Romania
facility: GSK Investigational Site
city: Balenyà (Barcelona)
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Centelles
country: Spain
facility: GSK Investigational Site
city: La Roca Del Valles (Barcelona)
country: Spain
facility: GSK Investigational Site
city: Vic/ Barcelona
country: Spain
facility: GSK Investigational Site
city: Taichung
country: Taiwan
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
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.