Evaluation of the Safety and Immunogenicity of the Influenza Vaccine GSK2186877A in the Elderly. - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00772889

Purpose

The purpose of this observer-blind clinical trial is to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' influenza vaccine GSK2186877A in the elderly. Subjects were previously vaccinated (NCT00529516).

Condition	Intervention	Phase
Influenza Infection	Biological: GSK Biologicals' Fluarix™ Biological: Influenza vaccine GSK2186877A	Phase III

MedlinePlus related topics: Autoimmune Diseases Flu

Drug Information available for: Influenza Vaccines Fluvirin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety Study
Official Title:	Safety and Immunogenicity of the Influenza Vaccine GSK2186877A in the Elderly.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Occurrence, intensity and duration of solicited local symptoms [ Time Frame: days 0 to 6 ] [ Designated as safety issue: Yes ]
Occurrence, intensity, duration and relationship to vaccination of solicited general symptoms [ Time Frame: days 0 to 6 ] [ Designated as safety issue: Yes ]
Occurrence, intensity and relationship to vaccination of unsolicited adverse events (including serious adverse events and adverse events of specific interest including autoimmune diseases) [ Time Frame: days 0 to 20 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Occurrence and relationship to vaccination of serious adverse events and adverse events of specific interest including autoimmune diseases [ Time Frame: From Day 21 to Day 180. ] [ Designated as safety issue: Yes ]
Occurrence and relationship to vaccination of adverse events with medically attended visit [ Time Frame: Day 21 to Day 180. ] [ Designated as safety issue: Yes ]
Haemagglutination-inhibition (HI) antibody titres [ Time Frame: At Day 0 and 21 ] [ Designated as safety issue: No ]

Estimated Enrollment:	1252
Study Start Date:	October 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group B: Active Comparator <= 488 subjects aged >= 66 years receiving one dose of Fluarix.	Biological: GSK Biologicals' Fluarix™ One intramuscularly injection at Day 0
Group C: Active Comparator <= 289 subjects aged 19-43 years receiving one dose of Fluarix.	Biological: GSK Biologicals' Fluarix™ One intramuscularly injection at Day 0
Group A: Experimental <= 475 subjects aged >= 66 years receiving one dose of the GSK2186877A vaccine.	Biological: Influenza vaccine GSK2186877A One intramuscularly injection at Day 0

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

A male or female subject previously enrolled in study 109821 (NCT 00529516) in the >= 65 years and 18-41 years of age groups and having received the study vaccine.
Subjects of whom the investigator believes that they can and will comply with the requirements of the protocol. Specific attention should be given to the compliance potential of subjects with suspected or known drug or alcohol abuse.
Written informed consent obtained from the subject.
Free of an acute aggravation of the health status as established by medical history and clinical 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, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.

Exclusion Criteria:

Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study.
Planned administration of a vaccine not foreseen by the study protocol up to 30 days after vaccination.
Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
Any vaccination against influenza since January 2008 with any seasonal influenza vaccine.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
History of hypersensitivity to a previous dose of influenza vaccine.
History of allergy or reactions likely to be exacerbated by any component of the vaccines.
Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or pre-existing laboratory screening tests.
Acute disease at the time of enrolment.
Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned administration during the study period.
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days prior to vaccination, or planned use during the study period.
Any medical conditions in which intramuscular injections are contraindicated.
Pregnant or lactating females.
Female planning to become pregnant or planning to discontinue contraceptive precautions.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00772889

Show 29 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	111738
Study First Received:	October 10, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00772889
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Influenza
Vaccine
Elderly

Study placed in the following topic categories:

Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

Additional relevant MeSH terms:

RNA Virus Infections
Infection

ClinicalTrials.gov processed this record on January 14, 2009