Influenza Monovalent Whole virus (H5N1) adjuvanted vaccine
Biological2 doses administered intramuscularly at the deltoid region of the non-dominant arm at Days 0 and 21
NCT Number: NCT00309647
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.
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Notify Me18 year–60 year
All sexes
Interventional
Phase 1
GSK Investigational Site, Finsterwalde, Brandenburg, Germany
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
2 doses administered intramuscularly at the deltoid region of the non-dominant arm at Days 0 and 21
2 doses administered intramuscularly at the deltoid region of the non-dominant arm at Days 0 and 21
Time frame: At Days 0, 21, 42 and 180
Geometric mean titers (GMTs) of serum antibodies
Time frame: At days 21, 42 and 180
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
Time frame: During a 21 day follow-up period after the first vaccination and 30 day follow-up period after the second vaccination
Time frame: During the entire study (Days 0 to 180)
Time frame: At Days 0, 21, 42 and 180
Geometric mean titers (GMTs) of serum antibodies
Time frame: At days 0, 21, 42 and 180
Time frame: At Days 21, 42 and 180
GlaxoSmithKline
Industry
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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