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Study to Evaluate the Safety and Immunogenicity of Pandemic Monovalent (H5N1) Influenza Vaccines (Whole Virus Formulation) in Adults 18 and 60 Years of Age

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00309647
First Posted: April 3, 2006
Last Update Posted: May 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
Today, the leading contender for the next pandemic of influenza is H5N1, a strain of avian virus. Prevention and control of a pandemic will depend on the rapid production and worldwide distribution of specific pandemic vaccines. Candidate 'pandemic-like' vaccines must be developed and tested in clinical trials to determine the most optimal formulation and the best vaccination schedule.This study is designed to test in healthy adults aged between 18-60 years the reactogenicity and immunogenicity of one and two administrations of a candidate pandemic H5N1 vaccine formulated from Whole Virus. The vaccines contain different antigen doses. For each dose, adjuvanted vaccine will be compared to the plain vaccine in order to detect the optimal formulation for immunization against the H5N1 influenza strain.

Condition Intervention Phase
Influenza Biological: Influenza Monovalent Whole virus (H5N1) adjuvanted vaccine Biological: Influenza Monovalent Whole virus (H5N1) Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: A Partially-blind Multi-centric Study in Adults Aged Between 18-60 Years Designed to Evaluate the Reactogenicity and Immunogenicity of 1 and 2 Doses of Pandemic Monovalent (H5N1) Influenza Vaccines (Whole Virus Formulation) Administered at Different Doses and Adjuvanted or Not

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • To evaluate the humoral immune response induced by the study vaccines in term of anti-haemagglutinin antibody titers [ Time Frame: At Days 0, 21, 42 and 180 ]
    Geometric mean titers (GMTs) of serum antibodies

  • To evaluate the humoral immune response induced by the study vaccines in terms of seroconversion rates (SCRs), Conversion factors and protection rates to H5N1 virus [ Time Frame: At days 21, 42 and 180 ]
  • Occurrence of solicited local and general adverse events [ Time Frame: During a 7 day follow-up period (i.e. day of vaccination and 6 subsequent days) after each dose of vaccine and overall ]
  • Occurrence of unsolicited adverse events [ Time Frame: During a 21 day follow-up period after the first vaccination and 30 day follow-up period after the second vaccination ]
  • Occurrence of serious adverse events [ Time Frame: During the entire study (Days 0 to 180) ]

Secondary Outcome Measures:
  • To evaluate the humoral immune response induced by the study vaccines in term of serum neutralizing antibody titers [ Time Frame: At Days 0, 21, 42 and 180 ]
    Geometric mean titers (GMTs) of serum antibodies

  • To evaluate the cell-mediated immune response induced by the study vaccines in term of frequency of influenza-specific CD4/CD8 T lymphocytes [ Time Frame: At days 0, 21, 42 and 180 ]
  • To evaluate the humoral immune response induced by the study vaccines in terms of SCR for serum neutralizing antibody titers [ Time Frame: At Days 21, 42 and 180 ]

Enrollment: 400
Actual Study Start Date: March 29, 2006
Study Completion Date: November 16, 2006
Primary Completion Date: November 1, 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: H5N1 Formulation 1 Group
Subjects in this group received 2 doses of H5N1 adjuvanted formulation 1 vaccine at a 21-day interval
Biological: Influenza Monovalent Whole virus (H5N1) adjuvanted vaccine
2 doses administered intramuscularly at the deltoid region of the non-dominant arm at Days 0 and 21
Experimental: H5N1 Formulation 2 Group
Subjects in this group received 2 doses of H5N1 adjuvanted formulation 2 vaccine at a 21-day interval
Biological: Influenza Monovalent Whole virus (H5N1) adjuvanted vaccine
2 doses administered intramuscularly at the deltoid region of the non-dominant arm at Days 0 and 21
Experimental: H5N1 Formulation 3 Group
Subjects in this group received 2 doses of H5N1 adjuvanted formulation 3 vaccine at a 21-day interval
Biological: Influenza Monovalent Whole virus (H5N1) adjuvanted vaccine
2 doses administered intramuscularly at the deltoid region of the non-dominant arm at Days 0 and 21
Experimental: H5N1 Formulation 4 Group
Subjects in this group received 2 doses of H5N1 adjuvanted formulation 4 vaccine at a 21-day interval
Biological: Influenza Monovalent Whole virus (H5N1) adjuvanted vaccine
2 doses administered intramuscularly at the deltoid region of the non-dominant arm at Days 0 and 21
Active Comparator: H5N1 Formulation 5 Group
Subjects in this group received 2 doses of H5N1 formulation 5 vaccine at a 21-day interval
Biological: Influenza Monovalent Whole virus (H5N1)
2 doses administered intramuscularly at the deltoid region of the non-dominant arm at Days 0 and 21
Active Comparator: H5N1 Formulation 6 Group
Subjects in this group received 2 doses of H5N1 formulation 6 vaccine at a 21-day interval
Biological: Influenza Monovalent Whole virus (H5N1)
2 doses administered intramuscularly at the deltoid region of the non-dominant arm at Days 0 and 21
Active Comparator: H5N1 Formulation 7 Group
Subjects in this group received 2 doses of H5N1 formulation 7 vaccine at a 21-day interval
Biological: Influenza Monovalent Whole virus (H5N1)
2 doses administered intramuscularly at the deltoid region of the non-dominant arm at Days 0 and 21
Active Comparator: H5N1 Formulation 8 Group
Subjects in this group received 2 doses of H5N1 formulation 8 vaccine at a 21-day interval
Biological: Influenza Monovalent Whole virus (H5N1)
2 doses administered intramuscularly at the deltoid region of the non-dominant arm at Days 0 and 21

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • A male or female between, and including, 18 and 60 years of age at the time of the first vaccination.
  • 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.

Exclusion criteria:

  • Administration of any vaccine during the period starting 15 days before the first administration of the study vaccine and ending 21 after the second one.
  • Administration of an influenza vaccine other than the study vaccines during the entire study period.
  • 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
  • History of hypersensitivity to vaccines.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • 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.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the first administration of the study vaccine or during the study.
  • lactating women
  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00309647


Locations
Germany
GSK Investigational Site
Finsterwalde, Brandenburg, Germany, 03238
GSK Investigational Site
Tostedt, Niedersachsen, Germany, 21255
GSK Investigational Site
Dresden, Sachsen, Germany, 01129
GSK Investigational Site
Dresden, Sachsen, Germany, 01307
GSK Investigational Site
Freiberg, Sachsen, Germany, 09599
GSK Investigational Site
Geringswalde, Sachsen, Germany, 09326
GSK Investigational Site
Schmiedeberg, Sachsen, Germany, 01762
GSK Investigational Site
Bad Segeberg, Schleswig-Holstein, Germany, 23795
GSK Investigational Site
Elmshorn, Schleswig-Holstein, Germany, 25335
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00309647     History of Changes
Other Study ID Numbers: 106378
First Submitted: March 31, 2006
First Posted: April 3, 2006
Last Update Posted: May 8, 2017
Last Verified: May 2017

Keywords provided by GlaxoSmithKline:
prophylaxis of pandemic influenza

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs