Evaluate Safety & Immunogenicity of a Pandemic Influenza Vaccine (GSK1562902A) in Adults Over 60 Years of Age

NCT00397215 | Completed Phase 2 Results

• 5 other identifiers: 1082511082521112751112762006-004041-42
• Study Type: interventional
• Target: 437
• Locations: 2 countries
• Sites: 12

Brief Summary

The present study is designed to evaluate the immunogenicity and safety of a single or double dose of the pandemic influenza candidate vaccine (GSK1562902A), administered following a two-administration schedule (21 days apart) in adults over 60 years of age. The persistence of influenza antibodies will also be evaluated 24 months after vaccination.

Conditions

Influenza

Keywords

H5N1; influenza; vaccine

Outcome Measures

Primary Outcomes (24)

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

  Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.

  At Days 0, 21 and 42

• Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease.

  The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).

  At Days 21 and 42

• Number of Seroprotected Subjects Against 2 Strains of Influenza Disease

  A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).

  At Days 0, 21 and 42

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

  Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:28. This outcome only covers results from the adjuvanted groups.

  At Days 0 and 42

• Number of Seroconverted Subjects Against 2 Strains of Influenza Disease.

  A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer \<1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).

  At Days 21 and 42

• Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease.

  A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer \<1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). This outcome only covers results from the adjuvanted groups.

  At Day 42

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

  Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.

  At Day 180

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

  Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.

  At Month 12

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

  Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.

  At Month 24

• Number of Seroconverted Subjects Against 2 Strains of Influenza Disease.

  A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer \<1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).

  At Day 180

• Number of Seroconverted Subjects Against 2 Strains of Influenza Disease.

  A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer \<1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).

  At Month 12

• Number of Seroconverted Subjects Against 2 Strains of Influenza Disease.

  A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer \<1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).

  At Month 24

• Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease.

  The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).

  At Day 180

• Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease

  The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).

  At Month 12

• Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease

  The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).

  At Month 24

• Number of Seroprotected Subjects Against 2 Strains of Influenza Disease

  A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).

  At Day 180

• Number of Seroprotected Subjects Against 2 Strains of Influenza Disease

  A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).

  At Month 12

• Number of Seroprotected Subjects Against 2 Strains of Influenza Disease

  A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).

  At Month 24

• Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease.

  A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer \<1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). This outcome only covers results from the adjuvanted groups.

  At Day 180

• Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease.

  A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer \<1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). This outcome only covers results from the adjuvanted groups.

  At Month 12

• Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease.

  A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer \<1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). This outcome only covers results from the adjuvanted groups.

  At Month 24

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

  Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:28. This outcome only covers results from the adjuvanted groups.

  At Month 12

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

  Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:28. This outcome only covers results from the adjuvanted groups.

  At Month 24

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

  Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:28. This outcome only covers results from the adjuvanted groups.

  At Day 180

Secondary Outcomes (12)

• Number of Subjects With Adverse Events of Specific Interest (AESIs)

  During the entire study period (Day 0 to Month 24)

• Number of Subjects With Any and Grade 3 Solicited Local Symptoms.

  During the 7-day follow-up period (Days 0 to 6) after any vaccination

• Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters.

  At Days 0, 2, 21 and 23

• Number of Subjects With Serious Adverse Events (SAEs)

  During the entire study period (Day 0 to Month 24).

• Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).

  During the 21-day (Days 0-20) follow-up period after first vaccination and during the 30-day (Days 0-29) follow-up period after second vaccination

Study Arms (4)

GSK1562902A 1 Group

EXPERIMENTAL

Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.

Biological: Pandemic influenza vaccine (GSK1562902A) (adjuvanted or not); Biological: Fluarix

GSK1562902A 2 Group

EXPERIMENTAL

Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.

Biological: Pandemic influenza vaccine (GSK1562902A) (adjuvanted or not); Biological: Fluarix

GSK1562902A 3 Group

EXPERIMENTAL

Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in the deltoid region of each arm.

Biological: Pandemic influenza vaccine (GSK1562902A) (adjuvanted or not); Biological: Fluarix

GSK1562902A 4 Group

EXPERIMENTAL

Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in the deltoid region of each arm.

Biological: Pandemic influenza vaccine (GSK1562902A) (adjuvanted or not); Biological: Fluarix

Interventions

Pandemic influenza vaccine (GSK1562902A) (adjuvanted or not) BIOLOGICAL

intramuscular injection

GSK1562902A 1 Group; GSK1562902A 2 Group; GSK1562902A 3 Group; GSK1562902A 4 Group

Fluarix BIOLOGICAL

Intramuscular injection. All subjects not vaccinated with an influenza vaccine for the 2006-2007 season received Fluarix NH 2006/2007 (i.e. interpandemic GSK's influenza vaccine) at least 3 weeks before administration of the first dose of H5N1 vaccine.

GSK1562902A 1 Group; GSK1562902A 2 Group; GSK1562902A 3 Group; GSK1562902A 4 Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
• A male or female aged 61 years or above at the time of the first vaccination.
• Written informed consent obtained from the subject.
• Healthy subjects or subjects with well controlled underlying disease.

You may not qualify if:

• Administration of the licensed MF59-containing vaccines, e.g. Fluad™ or Addigrip™ or virosome-based influenza vaccines such as Inflexal V™, InfectoVac Flu™ or Invivac™ during the 2006-2007 influenza season.
• Administration of 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 the second vaccination with H5N1 vaccine.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first administration of the study vaccine.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
• History of chronic alcohol consumption and/or drug abuse.
• History of hypersensitivity to vaccines.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine (including egg and thiomersal allergy).
• Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
• Acute disease at the time of enrolment.
• Serious chronic disease including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination.
• Administration of immunoglobulins and/or any blood products within the three months preceding the first vaccination or during the study.
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to the first vaccination, or planned use during the study period.
• Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (12)

GSK Investigational Site

Dour, 7370, Belgium

Location

GSK Investigational Site

Gozée, 6534, Belgium

Location

GSK Investigational Site

Libramont, 6800, Belgium

Location

GSK Investigational Site

Mont-Godinne, 5530, Belgium

Location

GSK Investigational Site

Sprimont, 4140, Belgium

Location

GSK Investigational Site

Tessenderlo, 3980, Belgium

Location

GSK Investigational Site

Watermael-Boitsfort, 1170, Belgium

Location

GSK Investigational Site

Genoa, Liguria, 16132, Italy

Location

GSK Investigational Site

Milan, Lombardy, 20127, Italy

Location

GSK Investigational Site

Monserrato Cagliari, Sardinia, 09042, Italy

Location

GSK Investigational Site

Sassari, Sardinia, 07100, Italy

Location

GSK Investigational Site

Ragusa, Sicily, 97100, Italy

Location

Related Publications (2)

• Gillard P, Giet D, Heijmans S, Drame M, Walravens K, Roman F. Long-term outcome of the humoral and cellular immune response of an H5N1 adjuvanted influenza vaccine in elderly persons: 2-year follow-up of a randomised open-label study. Trials. 2014 Oct 29;15:419. doi: 10.1186/1745-6215-15-419.

  PMID: 25354581 BACKGROUND

• Heijmans S, De Meulemeester M, Reynders P, Giet D, Demanet E, Devresse PY, Icardi G, Drame M, Roman F, Gillard P. Immunogenicity profile of a 3.75-mug hemagglutinin pandemic rH5N1 split virion AS03A-adjuvanted vaccine in elderly persons: a randomized trial. J Infect Dis. 2011 Apr 15;203(8):1054-62. doi: 10.1093/infdis/jiq174.

  PMID: 21450995 BACKGROUND

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

Nuclear Receptor Subfamily 4, Group A, Member 2; fluarix

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Orphan Nuclear Receptors; DNA-Binding Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Cytoplasmic and Nuclear

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: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2006
• First Posted: November 8, 2006
• Study Start: November 17, 2006
• Primary Completion: September 14, 2009
• Study Completion: September 14, 2009
• Last Updated: June 10, 2019
• Results First Posted: May 20, 2013

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will share

Locations

IT (5); BE (7)