Safety and Immune Response Study of GSK Biologicals' Influenza Virus Vaccine 1388442A Compared With Fluarix - Full Text View

Purpose

The purpose of the study is to compare the safety of & immune response to a single dose of GSK Biologicals' cell-culture based influenza vaccine 138842A with that of a US licensed, egg-based trivalent influenza vaccine [Fluarix] in healthy adults.

Condition	Intervention	Phase
Influenza Vaccines Seasonal Influenza	Biological: Trivalent influenza vaccine GSK 138842A Biological: Fluarix	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Safety and Immunogenicity Study of GSK Biologicals' Cell Culture-based Influenza Virus Vaccine 1388442A Compared With US Licensed TIV in Healthy 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:

Number of Subjects With Solicited Local Symptoms. [ Time Frame: During the 7-day (Days 0-6) post vaccination period ] [ Designated as safety issue: No ]
Solicited local symptoms were pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity.
Number of Subjects With Solicited General Symptoms. [ Time Frame: During the 7-day (Days 0-6) post vaccination period ] [ Designated as safety issue: No ]
Solicited general symptoms were arthralgia, fatigue, headache, muscle aches, shivering and temperature, assessed as oral temperature above or equal (≥) 38.0 degrees Celsius (°C). Any = occurrence of a symptom regardless of intensity or relationship to vaccination.
Number of Subjects With Medically Attended Adverse Events (MAEs). [ Time Frame: During the entire study period (Days 0-182) ] [ Designated as safety issue: No ]
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 and hospitalization. Related MAE = MAE assessed by the investigator as related to the vaccination.
Number of Subjects With New Onset of Chronic Diseases (NOCDs). [ Time Frame: During the entire study period (Days 0-182) ] [ Designated as safety issue: No ]
NOCDs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.
Number of Subjects With Unsolicited Adverse Events (AEs). [ Time Frame: During the 90-day (Days 0-89) post-vaccination period ] [ Designated as safety issue: No ]
Unsolicited AEs cover any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any unsolicited AE = any unsolicited AE regardless of intensity or relationship to vaccination.
Number of Subjects With Serious Adverse Events (SAEs). [ Time Frame: During the entire study period (Days 0-182) ] [ Designated as safety issue: No ]
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.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies for 3 Strains of Influenza Disease. [ Time Frame: At Day 21 ] [ Designated as safety issue: No ]
Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. [ Time Frame: At Day 21 ] [ Designated as safety issue: No ]
A seroprotected subject was defined as a vaccinated subject with a serum HI antibody titer ≥ 1:40, a level of HI antibody that has been viewed as correlating with protection against influenza. The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. [ Time Frame: At Day 21 ] [ Designated as safety issue: No ]
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)
Geometric Mean Fold-rise (GMFR) in 3 Strains of Influenza Disease. [ Time Frame: At Day 0 and Day 21 ] [ Designated as safety issue: No ]
GMFR was defined as the geometric mean of the ratio of the post-vaccination inverse HI titer to the Day 0 inverse HI titer. The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)

Enrollment:	200
Study Start Date:	June 2008
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: GSK 1388442A Group Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Biological: Trivalent influenza vaccine GSK 138842A IM injection on Day 0
Active Comparator: Fluarix Group Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Biological: Fluarix IM injection on Day 0

Eligibility

Ages Eligible for Study:	18 Years to 49 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Subjects who the investigator believes can and will comply with the requirements of the protocol
A male or non-pregnant, non-lactating female between 18 and 49 years of age at the time of vaccination
Access to a telephone for scheduled follow-up telephone contacts
Ability to provide written informed consent
Healthy subjects as established by medical history and physical examination before entering into the study
If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination and continue such precautions for 2 months after receipt of the study vaccine. All women will have a pregnancy test on the day of vaccination.

Exclusion Criteria:

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period
Receipt of systemic glucocorticoids within 30 days of study enrollment
Administration of immunosuppressant, cytotoxic, or other immune-modifying drugs (other than glucocorticoids) or irradiation within 6 months prior to study enrollment or planned administration during the study period
Administration of immunoglobulins and/or blood products within 3 months prior to study enrollment or planned administration during the study period
Previous vaccination against influenza (2007-2008 influenza season)
History of anaphylactic or other allergic reaction to influenza vaccine, any other vaccine, or any vaccine component or excipient
History of Guillain-Barre Syndrome (GBS)
Acute disease, febrile illness, or upper respiratory infection at screening.
History of splenectomy
Any confirmed or suspected, acquired, congenital, or hereditary immunodeficiency or immunosuppressive condition (including human immunodeficiency virus [HIV]) based on medical history and physical examination
Acquired or congenital coagulation disorders or known thrombocytopenia
Current treatment with warfarin or heparin derivatives
Known use of an analgesic or antipyretic medication within 12 hours prior to treatment for the purposes of prophylaxis of adverse events
Any medical condition for which the US Advisory Committee on Immunization Practices recommends vaccination against influenza

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00693706

Locations

United States, Florida
GSK Investigational Site
Miami, Florida, United States, 33143
United States, Kansas
GSK Investigational Site
Lenexa, Kansas, United States, 66219

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00693706 History of Changes
Other Study ID Numbers:	110127
Study First Received:	June 2, 2008
Results First Received:	December 19, 2012
Last Updated:	February 7, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

cell culture
Safety
Influenza
Humans

Adults
Immunogenicity
Influenza vaccine
Vaccine

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 June 17, 2013