Safety and Immunogenicity Study of GSK Biologicals' Seasonal Influenza Candidate Vaccine (GSK2321138A) - Full Text View

Purpose

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 group E which will be open.

Condition	Intervention	Phase
Influenza Infection	Biological: Influenza vaccine GSK2321138A Biological: FluarixTM Biological: Influenza vaccine GSK2604409A	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Partially-blind Immunogenicity and Safety Study of GSK Biologicals' Seasonal Influenza Vaccine GSK2321138A in Adults.

Resource links provided by NLM:

MedlinePlus related topics: Flu

Drug Information available for: Influenza Vaccines

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Humoral immune response in terms of Haemagglutination inhibition (HI) antibodies [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
Humoral immune response in terms of HI antibodies [ Time Frame: Day 21 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Occurrence of local and general symptoms [ Time Frame: During a 7-day (Day 0 to 6) follow-up period after each vaccination ] [ Designated as safety issue: No ]
Occurrence of unsolicited Adverse Events (AEs) [ Time Frame: During a 21-day (Day 0 to 20) follow up period after vaccination ] [ Designated as safety issue: No ]
Occurrence of potential immune mediated diseases, of serious adverse events, and AEs with medically attended visits [ Time Frame: From the beginning (Day 0) up to the study end (Day 180) ] [ Designated as safety issue: No ]

Enrollment:	4659
Study Start Date:	October 2010
Study Completion Date:	June 2011
Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Group A Subjects will receive vaccine GSK2321138A lot 1.	Biological: Influenza vaccine GSK2321138A One intramuscular injection
Experimental: Group B Subjects will receive vaccine GSK2321138A lot 2.	Biological: Influenza vaccine GSK2321138A One intramuscular injection
Experimental: Group C Subjects will receive vaccine GSK2321138A lot 3.	Biological: Influenza vaccine GSK2321138A One intramuscular injection
Active Comparator: Group D Subjects will receive FluarixTM vaccine.	Biological: FluarixTM One intramuscular injection
Active Comparator: Group E Subjects will receive vaccine GSK2604409A.	Biological: Influenza vaccine GSK2604409A One intramuscular injection

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01204671

Show 42 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT01204671 History of Changes
Other Study ID Numbers:	114269
Study First Received:	September 16, 2010
Last Updated:	July 23, 2012
Health Authority:	Romania: Ministry of Health and Family Germany: German Federal Ministry of Health United States: Food and Drug Administration Spain:Agencia Espanola de Medicamentos y Productos Sanitarios Taiwan: Department of Health (DOH) Korea: Korea Food & Drug Administration

Keywords provided by GlaxoSmithKline:

influenza infection
GSK Biologicals influenza vaccine GSK2321138A

Additional relevant MeSH terms:

Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections

Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013