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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Influenza

Intervention: GSK A/turkey H5N1 Influenza vaccine (Biological)

Phase: Phase 2

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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.

Clinical Details

Official title: A Trial to Evaluate the Safety & Immunogenicity of Investigational Influenza Vaccine GSK1557484A in Adults 18-64 Yrs of Age

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Primary outcome:

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

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

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

Secondary outcome:

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

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

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

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

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.

Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) Virus Strains.

HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Indonesia/5/2005 (A/Indo) Virus Strains.

Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.

Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.

Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.

Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains

Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.

Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.

Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.

Number of Subjects With Medically-attended Adverse Events (MAEs).

Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).

Number of Subjects Reporting Serious Adverse Events (SAEs).

Detailed description: All enrolled subjects will receive 1 dose of study vaccine. All subjects will attend formal study center visits for safety and immunogenicity assessments on Days 0, 10, 42, 84, and 182 with a telephone safety contact on Day 364. This Protocol Posting has been updated according to Protocol amendment, 8 Dec 08

Eligibility

Minimum age: 18 Years. Maximum age: 64 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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. Exclusion Criteria:

- 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.

- Use of any investigational or non-registered product (drug or vaccine) or planned

participation in another investigational study within 30 days prior to study enrollment, or during the 12 months following test article administration. Use of any investigational or non-registered product with immunosuppressive properties is exclusionary at any time during the trial.

- 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.

Locations and Contacts

GSK Investigational Site, Huntsville, Alabama 35802, United States

GSK Investigational Site, Anaheim, California 92801, United States

GSK Investigational Site, Miami, Florida 33143, United States

GSK Investigational Site, Stockbridge, Georgia 30281, United States

GSK Investigational Site, Lenexa, Kansas 66219, United States

GSK Investigational Site, Missoula, Montana 59801, United States

GSK Investigational Site, Las Vegas, Nevada 89130, United States

GSK Investigational Site, Halifax, Nova Scotia B3K 6R8, Canada

GSK Investigational Site, Truro, Nova Scotia B2N 1L2, Canada

GSK Investigational Site, Sherbrooke, Quebec J1H 4J6, Canada

Additional Information

Related publications:

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. Erratum in: Vaccine. 2013 Jan 2;31(2):436-7. Dosage error in article text.

Risi G et al. Immunological priming induced by a two-dose series of H5N1 antigen, administered alone or in combination with two different doses of AS03 adjuvant system in adults: a randomized, observer-blind, booster dose, follow-up study. Abstract presented at the International Symposium on Respiratory Viral Infections - XIII (ISRVI). Rome, Italy, 13-16 March 2011.

Starting date: October 2008
Last updated: September 4, 2014

Page last updated: August 20, 2015

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