A/H1N1 Immunogenicity and Safety in Adults

Influenza Clinical Trial

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

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

• Influenza
• Influenza, Human
• Pandemic Influenza

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