Study to Demonstrate the Lot-to-lot Consistency and to Evaluate the Safety of an Adjuvanted Influenza Vaccine Candidate

NCT ID: NCT00321763

Last Updated: 2018-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 3124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-27
• Study Completion Date: 2006-07-07

Brief Summary

The purpose of this phase IIb study is to demonstrate the consistency of three lots of an adjuvanted influenza vaccine candidate and to evaluate the safety of this vaccine compared to Fluarix™ administered intramuscularly in elderly aged 60 years old and above.

Detailed Description

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

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

GSK1247446A Lot 1 Group

Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.

Group Type: EXPERIMENTAL

Candidate Influenza Vaccine GSK1247446A - 3 different formulations

Intervention Type: BIOLOGICAL

Single dose, Intramuscular injection

GSK1247446A Lot 2 Group

Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.

Group Type: EXPERIMENTAL

Candidate Influenza Vaccine GSK1247446A - 3 different formulations

Intervention Type: BIOLOGICAL

Single dose, Intramuscular injection

GSK1247446A Lot 3 Group

Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.

Group Type: EXPERIMENTAL

Candidate Influenza Vaccine GSK1247446A - 3 different formulations

Intervention Type: BIOLOGICAL

Single dose, Intramuscular injection

GSK1247446A Pooled Group

Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.

Group Type: EXPERIMENTAL

Candidate Influenza Vaccine GSK1247446A - 3 different formulations

Intervention Type: BIOLOGICAL

Single dose, Intramuscular injection

Fluarix Group

Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.

Group Type: ACTIVE_COMPARATOR

Fluarix TM

Intervention Type: BIOLOGICAL

Single dose, Intramuscular injection

Interventions

Candidate Influenza Vaccine GSK1247446A - 3 different formulations

Single dose, Intramuscular injection

Intervention Type: BIOLOGICAL

Fluarix TM

Single dose, Intramuscular injection

Intervention Type: BIOLOGICAL

Eligibility 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 hypersensitivity to a previous dose of influenza vaccine.
• 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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Tartu, , Estonia

GSK Investigational Site

Caen, , France

GSK Investigational Site

Gières, , France

GSK Investigational Site

Lagord, , France

GSK Investigational Site

Lille, , France

GSK Investigational Site

Montpellier, , France

GSK Investigational Site

Paris, , France

GSK Investigational Site

Poitiers, , France

GSK Investigational Site

Rouen, , France

GSK Investigational Site

Toulouse, , France

GSK Investigational Site

Haag, Bavaria, Germany

GSK Investigational Site

Höhenkirchen-Siegertsbrunn, Bavaria, Germany

GSK Investigational Site

Marktl, Bavaria, Germany

GSK Investigational Site

Oberaudorf, Bavaria, Germany

GSK Investigational Site

Ketzin, Brandenburg, Germany

GSK Investigational Site

Koenigslutter, Lower Saxony, Germany

GSK Investigational Site

Tostedt, Lower Saxony, Germany

GSK Investigational Site

Delitzsch, Saxony, Germany

GSK Investigational Site

Freital, Saxony, Germany

GSK Investigational Site

Kamenz, Saxony, Germany

GSK Investigational Site

Pirna, Saxony, Germany

GSK Investigational Site

Weißenberg, Saxony, Germany

GSK Investigational Site

Wolmirstedt, Saxony-Anhalt, Germany

GSK Investigational Site

Bad Bramstedt, Schleswig-Holstein, Germany

GSK Investigational Site

Athens, , Greece

GSK Investigational Site

Goudi / Athens, , Greece

GSK Investigational Site

Haidari, , Greece

GSK Investigational Site

Marousi, , Greece

GSK Investigational Site

Nikaia Piraeus, , Greece

GSK Investigational Site

Orestiáda, , Greece

GSK Investigational Site

Papagos/Athens, , Greece

GSK Investigational Site

Thessaloniki, , Greece

GSK Investigational Site

Elverum, , Norway

GSK Investigational Site

Hamar, , Norway

GSK Investigational Site

Paradis, , Norway

GSK Investigational Site

Stavanger, , Norway

GSK Investigational Site

Kazan', , Russia

GSK Investigational Site

Saratov, , Russia

GSK Investigational Site

Yekaterinburg, , Russia

GSK Investigational Site

Reading, Berkshire, United Kingdom

GSK Investigational Site

Cardiff, Glamorgan, United Kingdom

GSK Investigational Site

Glasgow, Lanarkshire, United Kingdom

GSK Investigational Site

Buckshaw Village, Chorley, Lancashire, United Kingdom

GSK Investigational Site

Edgbaston, Birmingham, , United Kingdom

GSK Investigational Site

Manchester, , United Kingdom

GSK Investigational Site

Waterloo, Liverpool, , United Kingdom

Countries

Estonia; France; Germany; Greece; Norway; Russia; United Kingdom

Study Documents

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

107214

Identifier Type: OTHER

Identifier Source: secondary_id

107192

Identifier Type: -

Identifier Source: org_study_id