Clinical trial NCT00959465: A/H1N1 Immunogenicity and Safety in Adults
Official title: An Open Label Phase 1/2 Study to Assess Immunogenicity and Safety of Different Dose Levels of H1N1 Pandemic Influenza Vaccine in Healthy Adults Aged 18 Years and Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Influenza
Pandemic Influenza
Lead sponsor: Resilience Government Services, Inc.
Sponsor class: INDUSTRY
First posted: 2009-08-14
Enrollment: 408
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to obtain immunogenicity and safety data at different dose levels of an investigational H1N1 pandemic influenza vaccine in healthy adults 18 years of age and older.


Eligibility criteria: Inclusion Criteria:

* Subject is 18 to 59 years old (age stratum A) or 60 years of age or older (age stratum B) at the time of screening
* Subject has an understanding of the study, agrees to its provisions, and gives written informed consent prior to study entry
* Subject is generally healthy, as determined by the investigator's clinical judgment through collection of medical history and the performance of a physical examination
* Subject is physically and mentally capable of participating in the study and willing to adhere to study procedures to include completion of all elements of the study diary
* If female of childbearing potential, subject has a negative urine pregnancy test result within 24 hours prior to the scheduled first vaccination and agrees to employ adequate birth control measures for the duration of the study

Exclusion Criteria:

* Subject has participated in another clinical study involving an investigational drug, biological product or device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving an investigational drug, biological or device during the course of this study
* Subject has a history of exposure to A/H1N1/California/07/2009 virus or a history of vaccination with A/H1N1/California/07/2009 antigen or a closely related influenza virus antigen
* Subject has inherited or acquired immune deficiency
* Subject currently has or has a recent history of significant neurological, cardiovascular or pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorder

Primary outcomes:
measure: Number of subjects achieving antibody levels to A/H1N1/California/07/2009 virus that meet the definition of seroprotection and seroconversion at 21 days after the second vaccination
timeFrame: 42 days
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Sanatorium Leech
city: Vienna
country: Austria
facility: ClinPharm International GmbH
city: Vienna
country: Austria
facility: Medical University of Vienna, Institute for Specific Prophylaxis and Tropical Medicine
city: Vienna
country: Austria
facility: University Hospital, Department of Clinical Pharmacology
city: Mainz
country: Germany
facility: Praxis Regner Schmitt
Study officials:
affiliation: Baxter Healthcare Corporation
name: Gerald Aichinger, MD
role: STUDY_DIRECTOR
References: