A Trial to Test the Response to Different Vaccination Regimens With an H5N1 Vaccine With AS03 in Adults Aged 18-64

NCT00695669 | Completed Phase 2 Results

• 1 other identifier: 111626
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of the study is to characterize the immunogenicity \& safety of 2 doses of GSK's avian flu vaccine GSK 1557484A given according to different regimens to adults aged 18 to 64 years

Conditions

Influenza

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.

  A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal hemagglutination inhibition (HI) titer less than (\<) 1:10 and a post-vaccination (at Day 14 post Dose 2) reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination (at Day 14 post Dose 2) titer.

  At Day 14 post Dose 2

• Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.

  Titers are presented as geometric mean titers (GMTs). The Confidence Interval for this outcome was 98.75%.

  At Day 0 and at Day 14 post Dose 2

• Number of Seroprotected Subjects Against 3 Strains the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.

  A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40.

  At Day 0 and at Day 14 post Dose 2

Secondary Outcomes (23)

• Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.

  At Days 0, 21, 28, 35, 42 and 182.

• Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.

  At Days 0, 14, 21, 28, 35, 42 and 182.

• Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.

  At Days 0, 7, 14, 21, 28, 42 and 182.

• Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.

  At Days 0, 7, 14, 21, 42 and 182.

• Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.

  At Days 0, 21, 28, 35, 42 and 182.

Study Arms (4)

Influenza A (H5N1) 1 Group

EXPERIMENTAL

Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.

Biological: Influenza A (H5N1) Virus Monovalent Vaccine

Influenza A (H5N1) 2 Group

EXPERIMENTAL

Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.

Biological: Influenza A (H5N1) Virus Monovalent Vaccine

Influenza A (H5N1) 3 Group

EXPERIMENTAL

Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.

Biological: Influenza A (H5N1) Virus Monovalent Vaccine

Influenza A (H5N1) 4 Group

EXPERIMENTAL

Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.

Biological: Influenza A (H5N1) Virus Monovalent Vaccine

Interventions

Influenza A (H5N1) Virus Monovalent Vaccine BIOLOGICAL

Two doses administered intramuscularly (IM), the first in the deltoid region of the non-dominant arm and the second in the deltoid region of the dominant arm.

Influenza A (H5N1) 1 Group; Influenza A (H5N1) 2 Group; Influenza A (H5N1) 3 Group; Influenza A (H5N1) 4 Group

Eligibility Criteria

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

You may qualify if:

• A male or female 18-64 years old at the time of the first vaccination.
• Written informed consent obtained from the subject.
• Good general health as established by medical history and clinical examination before entering into the study.
• Access to a consistent means of telephone contact.
• Comprehension of the study requirements, ability to comprehend and comply with procedures for collection of short- and long-term safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits.
• Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study

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.
• Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible.
• Women who are disease-free 3 years or more after treatment for breast cancer and receiving long-term prophylactic tamoxifen are excepted and may be enrolled.
• Presence of an oral temperature ≥37.8ºC, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
• Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.
• Receipt of systemic glucocorticoids within 1 month of study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment.
• Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin.
• Administration of any vaccines within 30 days before study enrollment or during the 30 days following the last test article dose. Subjects who receive such immunizations on an emergent basis after enrollment will be followed per protocol and included in the Total Vaccinated Cohort (TVC), but excluded from the According to Protocol (ATP) Cohort for both safety and immunogenicity.
• Previous administration of any H5N1 vaccine.
• Receipt of any immunoglobulins and/or any blood products within 6 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 (including egg proteins or mercurial preservatives); 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 either 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 treatments. Note: all women will have urine pregnancy tests regardless of their status.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (3)

GSK Investigational Site

Greater Sudbury, Ontario, P3E 6C3, Canada

Location

GSK Investigational Site

Toronto, Ontario, M9W 4L6, Canada

Location

GSK Investigational Site

Québec, Quebec, G1W 4R4, Canada

Location

Related Publications (1)

• Lasko B, Reich D, Madan A, Roman F, Li P, Vaughn D. Rapid immunization against H5N1: a randomized trial evaluating homologous and cross-reactive immune responses to AS03(A)-adjuvanted vaccination in adults. J Infect Dis. 2011 Aug 15;204(4):574-81. doi: 10.1093/infdis/jir328.

  PMID: 21791660 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: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2008
• First Posted: June 12, 2008
• Study Start: June 5, 2008
• Primary Completion: August 13, 2008
• Study Completion: January 8, 2009
• Last Updated: July 31, 2018
• Results First Posted: February 7, 2014

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

CA (3)