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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00959465
Other study ID # 820902
Secondary ID EUDRACT Number 2
Status Completed
Phase Phase 1/Phase 2
First received August 13, 2009
Last updated October 7, 2015
Start date August 2009
Est. completion date April 2010

Study information

Verified date July 2010
Source Nanotherapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority Austria: Federal Ministry for Health Family and YouthGermany: Paul-Ehrlich-Institut
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 408
Est. completion date April 2010
Est. primary completion date November 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Biological:
H1N1 pandemic influenza vaccine (whole virion, Vero Cell-derived, inactivated)
Two injections at a 21-day interval (Days 1 and 22)

Locations

Country Name City State
Austria Sanatorium Leech Graz
Austria ClinPharm International GmbH Vienna
Austria Medical University of Vienna, Institute for Specific Prophylaxis and Tropical Medicine Vienna
Austria University Hospital, Department of Clinical Pharmacology Vienna
Germany Praxis Regner Schmitt Mainz

Sponsors (1)

Lead Sponsor Collaborator
Nanotherapeutics, Inc.

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 42 days Yes
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