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

Phase 1

Completed

• Conditions: Influenza
• Interventions: Biological: Influenza Monovalent Whole virus (H5N1); Biological: Influenza Monovalent Whole virus (H5N1) adjuvanted vaccine

• Registration Number: NCT00309647
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-03-29
• Study First Submitted: 2006-03-31
• Study First Submitted QC: 2006-03-31
• Study First Posted: 2006-04-03
• Primary Completion: 2006-11-01
• Study Completion: 2006-11-16
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-05
• Last Update Posted: 2017-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
H5N1 Formulation 8 Group	Influenza Monovalent Whole virus (H5N1)	Subjects in this group received 2 doses of H5N1 formulation 8 vaccine at a 21-day interval
H5N1 Formulation 1 Group	Influenza Monovalent Whole virus (H5N1) adjuvanted vaccine	Subjects in this group received 2 doses of H5N1 adjuvanted formulation 1 vaccine at a 21-day interval
H5N1 Formulation 5 Group	Influenza Monovalent Whole virus (H5N1)	Subjects in this group received 2 doses of H5N1 formulation 5 vaccine at a 21-day interval
H5N1 Formulation 2 Group	Influenza Monovalent Whole virus (H5N1) adjuvanted vaccine	Subjects in this group received 2 doses of H5N1 adjuvanted formulation 2 vaccine at a 21-day interval
H5N1 Formulation 4 Group	Influenza Monovalent Whole virus (H5N1) adjuvanted vaccine	Subjects in this group received 2 doses of H5N1 adjuvanted formulation 4 vaccine at a 21-day interval
H5N1 Formulation 6 Group	Influenza Monovalent Whole virus (H5N1)	Subjects in this group received 2 doses of H5N1 formulation 6 vaccine at a 21-day interval
H5N1 Formulation 7 Group	Influenza Monovalent Whole virus (H5N1)	Subjects in this group received 2 doses of H5N1 formulation 7 vaccine at a 21-day interval
H5N1 Formulation 3 Group	Influenza Monovalent Whole virus (H5N1) adjuvanted vaccine	Subjects in this group received 2 doses of H5N1 adjuvanted formulation 3 vaccine at a 21-day interval

Primary Outcome Measures

Name	Time	Method
Occurrence of unsolicited adverse events	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	During the entire study (Days 0 to 180)
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	At days 21, 42 and 180
To evaluate the humoral immune response induced by the study vaccines in term of anti-haemagglutinin antibody titers	At Days 0, 21, 42 and 180	Geometric mean titers (GMTs) of serum antibodies
Occurrence of solicited local and general adverse events	During a 7 day follow-up period (i.e. day of vaccination and 6 subsequent days) after each dose of vaccine and overall

Secondary Outcome Measures

Name	Time	Method
To evaluate the humoral immune response induced by the study vaccines in term of serum neutralizing antibody titers	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	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	At Days 21, 42 and 180

Trial Locations

Locations (1)

GSK Investigational Site; 🇩🇪 Elmshorn, Schleswig-Holstein, Germany