Study to Evaluate an Influenza Vaccine Candidate

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ClinicalTrials.gov Identifier: NCT00321373

Recruitment Status : Completed

First Posted : May 3, 2006

Results First Posted : May 1, 2013

Last Update Posted : June 8, 2018

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

Study Description

Brief Summary:

The purpose of this study is to evaluate the immune response and safety of influenza vaccine candidate with or without adjuvant compared to Fluarix™ administered intramuscularly in elderly aged 60 years old and above.

Condition or disease	Intervention/treatment	Phase
Influenza	Biological: Candidate Influenza Vaccine GSK1247446A - 2 different formulations Biological: FluarixTM	Phase 2

Detailed Description:

Subjects will be randomized into 3 groups and will be followed for 6 months with 4 scheduled contacts per subjects. The immune response will be evaluated at days 0, 21 and 180 after vaccination. The safety evaluation will involve follow-up of solicited local and general signs and symptoms, unsolicited adverse events and serious adverse events.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	1220 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Participant)
Primary Purpose:	Prevention
Official Title:	A Study to Demonstrate the Non-Inferiority of Influenza Vaccine Candidate, Compared With Fluarix™ Administered Intramuscularly in Elderly Aged 60 Years Old and Above
Study Start Date :	May 11, 2006
Actual Primary Completion Date :	July 1, 2006
Actual Study Completion Date :	July 18, 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Drug Information available for: Influenza Vaccines

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: GSK1247446A-AS03 Group Subjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Biological: Candidate Influenza Vaccine GSK1247446A - 2 different formulations Single dose, Intramuscular injection
Experimental: GSK1247446A Group Subjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Biological: Candidate Influenza Vaccine GSK1247446A - 2 different formulations Single dose, Intramuscular injection
Active Comparator: Fluarix Group Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Biological: FluarixTM Single dose, Intramuscular injection

Outcome Measures

Primary Outcome Measures :

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus [ Time Frame: At Days 0 and 21 post-vaccination ]
Titers are presented as geometric mean titers (GMTs). The 3 flu strains assessed were A/New Caledonia, A/New York and B/Malaysia. The reference seropositivity cut-off value was ≥ 1:10.

Secondary Outcome Measures :

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus [ Time Frame: At Day 180 post-vaccination. ]
Titers are presented as geometric mean titers (GMTs). The 3 flu strains assessed were A/New Caledonia, A/New York and B/Malaysia. The reference seropositivity cut-off value was ≥ 1:10.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms. [ Time Frame: During the 7-day (Days 0-6) follow-up period after vaccination ]
Assessed solicited local symptoms were ecchymosis, pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 ecchymosis/redness/swelling = ecchymosis/redness/swelling spreading beyond 50 millimeters (mm) of injection site.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. [ Time Frame: During the 7-day (Days 0-6) follow up period after vaccination ]
Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as oral temperature equal to or above 37.5 degrees Celsius (°C)], headache, muscle aches, shivering. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Number of Subjects With Unsolicited Adverse Events (AEs). [ Time Frame: During the 30-day (Days 0-29) follow-up period after vaccination ]
An unsolicited AE covers 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 and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Number of Subjects With Any and Related Serious Adverse Events (SAEs) [ Time Frame: During the entire study period (Day 0 to Day 180) ]
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Any = occurrence of any SAE regardless of intensity grade or relation to vaccination. Related = SAE assessed by the investigator as related to the vaccination.

Eligibility Criteria

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Ages Eligible for Study:	60 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion criteria:

A male or female age 60 years or older at the time of the vaccination.
Subjects who the investigator believes can and will comply with the requirements of the protocol
Written informed consent obtained from the subject.
Free of an acute aggravation of the health status as established by clinical examination before entering into the study.

Exclusion criteria:

Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
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.
History of hypersensivity to a previous dose of influenza vaccine.
Previous vaccination against influenza within the 9 months prior to enrollment.
History of confirmed influenza infection within the last 12 months.
History of allergy or reactions likely to be exacerbated by any component of the vaccine(s)
Acute disease at the time of enrolment.

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00321373

Locations


Finland
GSK Investigational Site
Helsinki, Finland, 00100
GSK Investigational Site
Helsinki, Finland, 00930
GSK Investigational Site
Jarvenpaa, Finland, 04400
GSK Investigational Site
Kotka, Finland, 48100
GSK Investigational Site
Lahti, Finland, 15140
GSK Investigational Site
Oulu, Finland, 90100
GSK Investigational Site
Pori, Finland, 28120
GSK Investigational Site
Tampere, Finland, 33200
GSK Investigational Site
Turku, Finland, 20520
GSK Investigational Site
Vantaa, Finland, 01300
GSK Investigational Site
Vantaa, Finland, 01600
Greece
GSK Investigational Site
Goudi / Athens, Greece, 115 27
GSK Investigational Site
Haidari, Greece, 124 62
GSK Investigational Site
Marousi, Greece, 151 26
GSK Investigational Site
Nikaia Piraeus, Greece, 184 54
GSK Investigational Site
Orestiada, Greece, 682 00
GSK Investigational Site
Thessaloniki, Greece, 54642

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

Additional Information:

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