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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

Primary Purpose

Influenza

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Influenza Monovalent Whole virus (H5N1) adjuvanted vaccine
Influenza Monovalent Whole virus (H5N1)
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring prophylaxis of pandemic influenza

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

H5N1 Formulation 1 Group

H5N1 Formulation 2 Group

H5N1 Formulation 3 Group

H5N1 Formulation 4 Group

H5N1 Formulation 5 Group

H5N1 Formulation 6 Group

H5N1 Formulation 7 Group

H5N1 Formulation 8 Group

Arm Description

Subjects in this group received 2 doses of H5N1 adjuvanted formulation 1 vaccine at a 21-day interval

Subjects in this group received 2 doses of H5N1 adjuvanted formulation 2 vaccine at a 21-day interval

Subjects in this group received 2 doses of H5N1 adjuvanted formulation 3 vaccine at a 21-day interval

Subjects in this group received 2 doses of H5N1 adjuvanted formulation 4 vaccine at a 21-day interval

Subjects in this group received 2 doses of H5N1 formulation 5 vaccine at a 21-day interval

Subjects in this group received 2 doses of H5N1 formulation 6 vaccine at a 21-day interval

Subjects in this group received 2 doses of H5N1 formulation 7 vaccine at a 21-day interval

Subjects in this group received 2 doses of H5N1 formulation 8 vaccine at a 21-day interval

Outcomes

Primary Outcome Measures

To evaluate the humoral immune response induced by the study vaccines in term of anti-haemagglutinin antibody titers
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
Occurrence of solicited local and general adverse events
Occurrence of unsolicited adverse events
Occurrence of serious adverse events

Secondary Outcome Measures

To evaluate the humoral immune response induced by the study vaccines in term of serum neutralizing antibody titers
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
To evaluate the humoral immune response induced by the study vaccines in terms of SCR for serum neutralizing antibody titers

Full Information

First Posted
March 31, 2006
Last Updated
May 5, 2017
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00309647
Brief Title
Study to Evaluate the Safety and Immunogenicity of Pandemic Monovalent (H5N1) Influenza Vaccines (Whole Virus Formulation) in Adults 18 and 60 Years of Age
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
March 29, 2006 (Actual)
Primary Completion Date
November 1, 2006 (Actual)
Study Completion Date
November 16, 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
prophylaxis of pandemic influenza

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
H5N1 Formulation 1 Group
Arm Type
Experimental
Arm Description
Subjects in this group received 2 doses of H5N1 adjuvanted formulation 1 vaccine at a 21-day interval
Arm Title
H5N1 Formulation 2 Group
Arm Type
Experimental
Arm Description
Subjects in this group received 2 doses of H5N1 adjuvanted formulation 2 vaccine at a 21-day interval
Arm Title
H5N1 Formulation 3 Group
Arm Type
Experimental
Arm Description
Subjects in this group received 2 doses of H5N1 adjuvanted formulation 3 vaccine at a 21-day interval
Arm Title
H5N1 Formulation 4 Group
Arm Type
Experimental
Arm Description
Subjects in this group received 2 doses of H5N1 adjuvanted formulation 4 vaccine at a 21-day interval
Arm Title
H5N1 Formulation 5 Group
Arm Type
Active Comparator
Arm Description
Subjects in this group received 2 doses of H5N1 formulation 5 vaccine at a 21-day interval
Arm Title
H5N1 Formulation 6 Group
Arm Type
Active Comparator
Arm Description
Subjects in this group received 2 doses of H5N1 formulation 6 vaccine at a 21-day interval
Arm Title
H5N1 Formulation 7 Group
Arm Type
Active Comparator
Arm Description
Subjects in this group received 2 doses of H5N1 formulation 7 vaccine at a 21-day interval
Arm Title
H5N1 Formulation 8 Group
Arm Type
Active Comparator
Arm Description
Subjects in this group received 2 doses of H5N1 formulation 8 vaccine at a 21-day interval
Intervention Type
Biological
Intervention Name(s)
Influenza Monovalent Whole virus (H5N1) adjuvanted vaccine
Intervention Description
2 doses administered intramuscularly at the deltoid region of the non-dominant arm at Days 0 and 21
Intervention Type
Biological
Intervention Name(s)
Influenza Monovalent Whole virus (H5N1)
Intervention Description
2 doses administered intramuscularly at the deltoid region of the non-dominant arm at Days 0 and 21
Primary Outcome Measure Information:
Title
To evaluate the humoral immune response induced by the study vaccines in term of anti-haemagglutinin antibody titers
Description
Geometric mean titers (GMTs) of serum antibodies
Time Frame
At Days 0, 21, 42 and 180
Title
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
Title
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
Title
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
Title
Occurrence of serious adverse events
Time Frame
During the entire study (Days 0 to 180)
Secondary Outcome Measure Information:
Title
To evaluate the humoral immune response induced by the study vaccines in term of serum neutralizing antibody titers
Description
Geometric mean titers (GMTs) of serum antibodies
Time Frame
At Days 0, 21, 42 and 180
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Finsterwalde
State/Province
Brandenburg
ZIP/Postal Code
03238
Country
Germany
Facility Name
GSK Investigational Site
City
Tostedt
State/Province
Niedersachsen
ZIP/Postal Code
21255
Country
Germany
Facility Name
GSK Investigational Site
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01129
Country
Germany
Facility Name
GSK Investigational Site
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Facility Name
GSK Investigational Site
City
Freiberg
State/Province
Sachsen
ZIP/Postal Code
09599
Country
Germany
Facility Name
GSK Investigational Site
City
Geringswalde
State/Province
Sachsen
ZIP/Postal Code
09326
Country
Germany
Facility Name
GSK Investigational Site
City
Schmiedeberg
State/Province
Sachsen
ZIP/Postal Code
01762
Country
Germany
Facility Name
GSK Investigational Site
City
Bad Segeberg
State/Province
Schleswig-Holstein
ZIP/Postal Code
23795
Country
Germany
Facility Name
GSK Investigational Site
City
Elmshorn
State/Province
Schleswig-Holstein
ZIP/Postal Code
25335
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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