Study to Evaluate an Influenza Vaccine Candidate

NCT00540228 | Completed Phase 2 Results

• 2 other identifiers: 1107942007-003776-18
• Study Type: interventional
• Target: 1,006
• Locations: 3 countries
• Sites: 15

Brief Summary

In order to find the formulation leading to a maximal increase of the immune response while maintaining an acceptable safety profile, this study is designed to evaluate the immunogenicity, safety and reactogenicity of the different formulations of GSK Biologicals' influenza vaccine administered in adults aged 18-64 years.

Conditions

Influenza

Keywords

Influenza; Influenza Vaccine

Outcome Measures

Primary Outcomes (1)

• Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.

  Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA). The seropositivity cut-off assay was 1:10. The results for Day 0 and Day 21 are the primary efficacy variables.

  At Days 0, 21 and 180

Secondary Outcomes (11)

• Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.

  At Days 21 and 180

• Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.

  At Days 21 and 180

• Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.

  At Days 0, 21 and 180

• Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.

  At Days 0 and 21

• Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.

  At Days 0, 21 and 180

Study Arms (5)

GSK1247446A 1 Group

EXPERIMENTAL

Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Biological: Influenza Vaccine GSK1247446A - 4 different formulations

GSK1247446A 2 Group

EXPERIMENTAL

Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Biological: Influenza Vaccine GSK1247446A - 4 different formulations

GSK1247446A 3 Group

EXPERIMENTAL

Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Biological: Influenza Vaccine GSK1247446A - 4 different formulations

GSK1247446A 4 Group

EXPERIMENTAL

Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Biological: Influenza Vaccine GSK1247446A - 4 different formulations

Fluarix Group

ACTIVE COMPARATOR

Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Biological: Fluarix™

Interventions

Influenza Vaccine GSK1247446A - 4 different formulations BIOLOGICAL

Single dose, Intramuscular injection

GSK1247446A 1 Group; GSK1247446A 2 Group; GSK1247446A 3 Group; GSK1247446A 4 Group

Fluarix™ BIOLOGICAL

Single dose, Intramuscular injection

Fluarix Group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Only subjects who the investigator believes that they can and will comply with the requirements of the protocol .
• A male or female between, and including, 18 - 64 years of age at the time of vaccination.
• Written informed consent obtained from the subject.
• Healthy subjects 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 have a negative pregnancy test, practice adequate contraception for 30 days prior to vaccination, and continue such precautions for 2 months after completion of the vaccination series.

You may not qualify if:

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose
• Administration of a vaccine not foreseen by the study protocol from 30 days before vaccination, up to 21 days after vaccination.
• History of hypersensitivity to a previous dose of influenza vaccine.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s)
• Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
• Confirmed influenza infection within a year preceding the study start.
• Administration of an influenza vaccine within a year preceding the study start.
• Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
• Pregnant or lactating female.
• Concurrent participation in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product
• Acute disease at the time of enrolment.
• History of chronic alcohol consumption and/or drug abuse.
• Female planning to become pregnant or planning to discontinue contraceptive precautions.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (15)

GSK Investigational Site

Caen, 14052, France

Location

GSK Investigational Site

Lagord, 17140, France

Location

GSK Investigational Site

Lille, 59019, France

Location

GSK Investigational Site

Paris, 75679, France

Location

GSK Investigational Site

Paris, 75877, France

Location

GSK Investigational Site

Toulouse, 31300, France

Location

GSK Investigational Site

Tübingen, Baden-Wurttemberg, 72074, Germany

Location

GSK Investigational Site

Würzburg, Bavaria, 97070, Germany

Location

GSK Investigational Site

Dresden, Saxony, 01307, Germany

Location

GSK Investigational Site

Freiberg, Saxony, 09599, Germany

Location

GSK Investigational Site

Schmiedeberg, Saxony, 01762, Germany

Location

GSK Investigational Site

Barcelona, 08035, Spain

Location

GSK Investigational Site

Barcelona, 08036, Spain

Location

GSK Investigational Site

Madrid, 28035, Spain

Location

GSK Investigational Site

Madrid, 28040, Spain

Location

Related Links

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

MeSH Terms

Conditions

Influenza, Human

Interventions

fluarix

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2007
• First Posted: October 5, 2007
• Study Start: October 5, 2007
• Primary Completion: May 8, 2008
• Study Completion: May 8, 2008
• Last Updated: June 14, 2019
• Results First Posted: April 30, 2013

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will share

Locations

FR (6); ES (4); DE (5)