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

NCT ID: NCT00309647

Last Updated: 2017-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-29
• Study Completion Date: 2006-11-16

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.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

H5N1 Formulation 1 Group

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

Group Type: EXPERIMENTAL

Influenza Monovalent Whole virus (H5N1) adjuvanted vaccine

Intervention Type: BIOLOGICAL

2 doses administered intramuscularly at the deltoid region of the non-dominant arm at Days 0 and 21

H5N1 Formulation 2 Group

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

Group Type: EXPERIMENTAL

Influenza Monovalent Whole virus (H5N1) adjuvanted vaccine

Intervention Type: BIOLOGICAL

2 doses administered intramuscularly at the deltoid region of the non-dominant arm at Days 0 and 21

H5N1 Formulation 3 Group

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

Group Type: EXPERIMENTAL

Influenza Monovalent Whole virus (H5N1) adjuvanted vaccine

Intervention Type: BIOLOGICAL

2 doses administered intramuscularly at the deltoid region of the non-dominant arm at Days 0 and 21

H5N1 Formulation 4 Group

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

Group Type: EXPERIMENTAL

Influenza Monovalent Whole virus (H5N1) adjuvanted vaccine

Intervention Type: BIOLOGICAL

2 doses administered intramuscularly at the deltoid region of the non-dominant arm at Days 0 and 21

H5N1 Formulation 5 Group

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

Group Type: ACTIVE_COMPARATOR

Influenza Monovalent Whole virus (H5N1)

Intervention Type: BIOLOGICAL

2 doses administered intramuscularly at the deltoid region of the non-dominant arm at Days 0 and 21

H5N1 Formulation 6 Group

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

Group Type: ACTIVE_COMPARATOR

Influenza Monovalent Whole virus (H5N1)

Intervention Type: BIOLOGICAL

2 doses administered intramuscularly at the deltoid region of the non-dominant arm at Days 0 and 21

H5N1 Formulation 7 Group

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

Group Type: ACTIVE_COMPARATOR

Influenza Monovalent Whole virus (H5N1)

Intervention Type: BIOLOGICAL

2 doses administered intramuscularly at the deltoid region of the non-dominant arm at Days 0 and 21

H5N1 Formulation 8 Group

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

Group Type: ACTIVE_COMPARATOR

Influenza Monovalent Whole virus (H5N1)

Intervention Type: BIOLOGICAL

2 doses administered intramuscularly at the deltoid region of the non-dominant arm at Days 0 and 21

Interventions

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

Intervention Type: BIOLOGICAL

Influenza Monovalent Whole virus (H5N1)

2 doses administered intramuscularly at the deltoid region of the non-dominant arm at Days 0 and 21

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Finsterwalde, Brandenburg, Germany

GSK Investigational Site

Tostedt, Lower Saxony, Germany

GSK Investigational Site

Dresden, Saxony, Germany

GSK Investigational Site

Dresden, Saxony, Germany

GSK Investigational Site

Freiberg, Saxony, Germany

GSK Investigational Site

Geringswalde, Saxony, Germany

GSK Investigational Site

Schmiedeberg, Saxony, Germany

GSK Investigational Site

Bad Segeberg, Schleswig-Holstein, Germany

GSK Investigational Site

Elmshorn, Schleswig-Holstein, Germany

Countries

Germany

Other Identifiers

106378

Identifier Type: -

Identifier Source: org_study_id