A/H1N1 Immunogenicity and Safety in Adults

Phase 1

Completed

• Conditions: Pandemic Influenza; Influenza
• Interventions: Biological: H1N1 pandemic influenza vaccine (whole virion, Vero Cell-derived, inactivated)

• Registration Number: NCT00959465
• Lead Sponsor: Resilience Government Services, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-13
• Study First Submitted QC: 2009-08-13
• Study First Posted: 2009-08-14
• Primary Completion: 2009-11
• Study Completion: 2010-04
• Status Verified: 2010-07
• Last Update Submitted: 2015-10-07
• Last Update Posted: 2015-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 408

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1/Dose Level A	H1N1 pandemic influenza vaccine (whole virion, Vero Cell-derived, inactivated)	Subjects in Cohort 1 will be randomized 1:1 to receive two vaccinations of Dose A or Dose B of H1N1 pandemic influenza vaccine at a 21-day interval.
Cohort 2/Dose C	H1N1 pandemic influenza vaccine (whole virion, Vero Cell-derived, inactivated)	A second cohort may be enrolled with all subjects in this cohort receiving two vaccinations of Dose C of H1N1 pandemic influenza vaccine at a 21-day interval.
Cohort 1/Dose B	H1N1 pandemic influenza vaccine (whole virion, Vero Cell-derived, inactivated)	Subjects in Cohort 1 will be randomized 1:1 to receive two vaccinations of Dose A or Dose B of H1N1 pandemic influenza vaccine at a 21-day interval.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

University Hospital, Department of Clinical Pharmacology; 🇦🇹 Vienna, Austria

Praxis Regner Schmitt; 🇩🇪 Mainz, Germany

Sanatorium Leech; 🇦🇹 Graz, Austria

ClinPharm International GmbH; 🇦🇹 Vienna, Austria

Medical University of Vienna, Institute for Specific Prophylaxis and Tropical Medicine; 🇦🇹 Vienna, Austria