Immunogenicity & Safety of GSK's Avian Flu Vaccine 1557484A Given to Adults Aged 18-64 Years

NCT00771615 | Completed Phase 2 Results

• 1 other identifier: 111729
• Study Type: interventional
• Target: 469
• Locations: 2 countries
• Sites: 10

Brief Summary

The purpose of this observer-blind study is to determine whether GSK's avian flu vaccine GSK 1557484A is immunogenic when given to adults aged 18-64 years.

Conditions

Influenza

Keywords

human; Avian; safety; vaccines; influenza; pandemic; immunogenicity; H5N1

Outcome Measures

Primary Outcomes (3)

• Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.

  A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) titer less than (\<) 1:10 for HI and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40, or a pre-vaccination reciprocal titer ≥ 1:10 for HI and at least a 4-fold increase in post-vaccination reciprocal titer.

  At Day 10

• Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain

  A seroprotected subject against the A/turkey virus strain was defined as a subject with serum HI antibody reciprocal titer ≥ 1:40 post-vaccination, a level of HI antibodies that may correlate with benefit in protection against influenza.

  At Day 10

• Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.

  HI antibody titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:10.

  At Day 10

Secondary Outcomes (17)

• Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains.

  At Day 0 to Day 42 and at Day 0 to Day 182

• Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 Virus Strain.

  At Day 0, Day 10, Day 42 and Day 182

• HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.

  At Day 0 to Day 10, Day 42 and Day 182

• HI Antibody Titers Against the A/Indonesia/5/2005 (A/Indo) Virus Strain.

  At Day 0, Day 10, Day 42 and Day 182

• Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains.

  At Day 0, Day 10, Day 42 and Day 182 for A/Indo and at Day 0, Day 42 and Day 182 for A/turkey virus strains.

Study Arms (9)

A/turkey H5N1 influenza Formulation A Group

EXPERIMENTAL

Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Biological: GSK A/turkey H5N1 Influenza vaccine

A/turkey H5N1 influenza Formulation B1 Group

EXPERIMENTAL

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Biological: GSK A/turkey H5N1 Influenza vaccine

A/turkey H5N1 influenza Formulation B2 Group

EXPERIMENTAL

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Biological: GSK A/turkey H5N1 Influenza vaccine

A/turkey H5N1 influenza Formulation C1 Group

EXPERIMENTAL

Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Biological: GSK A/turkey H5N1 Influenza vaccine

A/turkey H5N1 influenza Formulation C2 Group

EXPERIMENTAL

Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Biological: GSK A/turkey H5N1 Influenza vaccine

A/turkey H5N1 influenza Formulation D1 Group

EXPERIMENTAL

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Biological: GSK A/turkey H5N1 Influenza vaccine

A/turkey H5N1 influenza Formulation D2 Group

EXPERIMENTAL

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Biological: GSK A/turkey H5N1 Influenza vaccine

A/turkey H5N1 influenza Formulation E1 Group

EXPERIMENTAL

Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Biological: GSK A/turkey H5N1 Influenza vaccine

A/turkey H5N1 influenza Formulation E2 Group

EXPERIMENTAL

Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Biological: GSK A/turkey H5N1 Influenza vaccine

Interventions

GSK A/turkey H5N1 Influenza vaccine BIOLOGICAL

One dose administered intramuscularly (IM) in the deltoid region. Different formulations are tested.

A/turkey H5N1 influenza Formulation A Group; A/turkey H5N1 influenza Formulation B1 Group; A/turkey H5N1 influenza Formulation B2 Group; A/turkey H5N1 influenza Formulation C1 Group; A/turkey H5N1 influenza Formulation C2 Group; A/turkey H5N1 influenza Formulation D1 Group; A/turkey H5N1 influenza Formulation D2 Group; A/turkey H5N1 influenza Formulation E1 Group; A/turkey H5N1 influenza Formulation E2 Group

Eligibility Criteria

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

You may qualify if:

• Male and female adults 18 to 64 years of age at time of first vaccination, inclusive.
• Written informed consent obtained from the subject.
• Stable health status as defined by absence of a health event satisfying the definition of a SAE, or a change in an ongoing drug therapy due to therapeutic failure or symptoms of drug toxicity, within 1 month prior to enrollment.
• Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line, or mobile, but NOT a pay phone or other multiple-user device.
• Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits.
• Subjects who the investigator believes can and will comply with the requirements of the protocol.

You may not qualify if:

• Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, even if clinically stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
• Diagnosed with cancer, or treatment for cancer, within 3 years.
• Presence of an oral temperature \>= 37.8ºC, or acute symptoms greater than "mild" severity on the scheduled date of vaccination.
• Any confirmed or suspected immunosuppressive or immunodeficiency condition including history of human immunodeficiency virus (HIV) infection.
• Receipt of systemic glucocorticoids (prednisone \>= 10 mg/day for more than 14 consecutive days) within 1 month prior to study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment.
• An acute evolving neurological disorder or history of Guillain-Barré syndrome within 6 weeks of receipt of seasonal influenza vaccine.
• Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin.
• Administration of any vaccines within 30 days before the first study vaccine dose.
• Previous administration of any H5N1 vaccine.
• Receipt of any immunoglobulins and/or any blood products within 3 months of study enrollment or planned administration of any of these products during the study period.
• Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
• Known pregnancy or a positive urine beta-human chorionic gonadotropin (β-hCG) test result prior to vaccination.
• Lactating or nursing.
• Women of child bearing potential (who lack a history of reliable contraceptive practices. The provision of this history does NOT replace the requirement to perform, and obtain negative results in pregnancy urine tests prior to vaccination.
• Known receipt of analgesic or antipyretic medication with the specific intent of prophylaxis of vaccine reactogenicity on the day of vaccination. Subjects on stable chronic regimens of potentially analgesic or anti-pyretic medications for pre-existing diagnoses are not required to discontinue them.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (10)

GSK Investigational Site

Huntsville, Alabama, 35802, United States

Location

GSK Investigational Site

Anaheim, California, 92801, United States

Location

GSK Investigational Site

Miami, Florida, 33143, United States

Location

GSK Investigational Site

Stockbridge, Georgia, 30281, United States

Location

GSK Investigational Site

Lenexa, Kansas, 66219, United States

Location

GSK Investigational Site

Missoula, Montana, 59801, United States

Location

GSK Investigational Site

Las Vegas, Nevada, 89130, United States

Location

GSK Investigational Site

Halifax, Nova Scotia, B3K 6R8, Canada

Location

GSK Investigational Site

Truro, Nova Scotia, B2N 1L2, Canada

Location

GSK Investigational Site

Sherbrooke, Quebec, J1H 4J6, Canada

Location

Related Publications (1)

• Risi G, Frenette L, Langley JM, Li P, Riff D, Sheldon E, Vaughn DW, Fries L. Immunological priming induced by a two-dose series of H5N1 influenza antigen, administered alone or in combination with two different formulations of AS03 adjuvant in adults: results of a randomised single heterologous booster dose study at 15 months. Vaccine. 2011 Aug 26;29(37):6408-18. doi: 10.1016/j.vaccine.2011.04.072. Epub 2011 May 7.

  PMID: 21554915 DERIVED

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

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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2008
• First Posted: October 13, 2008
• Study Start: October 16, 2008
• Primary Completion: May 26, 2009
• Study Completion: December 4, 2009
• Last Updated: September 21, 2018
• Results First Posted: September 4, 2014

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

US (7); CA (3)