Study to Evaluate an Influenza Vaccine Candidate

Phase 2

Completed

• Conditions: Influenza
• Interventions: Biological: Candidate Influenza Vaccine GSK1247446A - 2 different formulations; Biological: FluarixTM

• Registration Number: NCT00321373
• Lead Sponsor: GlaxoSmithKline

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2006-03-16
• Study First Submitted QC: 2006-05-02
• Study First Posted: 2006-05-03
• Study Start: 2006-05-11
• Primary Completion: 2006-07-01
• Study Completion: 2006-07-18
• Results First Submitted: 2013-03-14
• Results First Submitted QC: 2013-03-14
• Results First Posted: 2013-05-01
• Status Verified: 2016-09
• Last Update Submitted: 2018-05-08
• Last Update Posted: 2018-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1220

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GSK1247446A-AS03 Group	Candidate Influenza Vaccine GSK1247446A - 2 different formulations	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.
GSK1247446A Group	Candidate Influenza Vaccine GSK1247446A - 2 different formulations	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.
Fluarix Group	FluarixTM	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.

Primary Outcome Measures

Name	Time	Method
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus	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

Name	Time	Method
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus	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.	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.	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).	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)	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.

Trial Locations

Locations (1)

GSK Investigational Site; 🇬🇷 Thessaloniki, Greece