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Safety and Immunogenicity of Preservative Free Inactivated Split Influenza Vaccine, Using the Strain Composition 2006/2007 in Non-Elderly Adult and Elderly Subjects

Primary Purpose

Influenza

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
preservative free inactivated split influenza vaccine using the strain composition 2006/2007
Sponsored by
Novartis
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring influenza, vaccine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy adults aged >18 years Exclusion Criteria: serious chronic diseases or significant acute infections requiring systemic antibiotic treatment history of any anaphylaxis, serious vaccine reactions hypersensitivity against vaccine components history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine known or suspected impairment/alteration of immune function more than one injection of influenza vaccine received or laboratory confirmed influenza disease within last 6 months: influenza vaccination received

Sites / Locations

  • Werksarztzentrum Herborn, Westerwaldstr 36,
  • Betriebsarztlicher Dienst, Universitat Marburg, Robert-Koch-Str, 5,

Outcomes

Primary Outcome Measures

antibody titers to each influenza strain measured by hemagglutination inhibition (HI) test on Day 0 and on Day 21

Secondary Outcome Measures

safety of a single IM dose of the split influenza vaccine using solicited local and systemic reactions and adverse event reporting

Full Information

First Posted
July 18, 2006
Last Updated
March 12, 2007
Sponsor
Novartis
Collaborators
Novartis Vaccines
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1. Study Identification

Unique Protocol Identification Number
NCT00354016
Brief Title
Safety and Immunogenicity of Preservative Free Inactivated Split Influenza Vaccine, Using the Strain Composition 2006/2007 in Non-Elderly Adult and Elderly Subjects
Official Title
A Phase III, Multicenter, Uncontrolled, Open-Label Study to Demonstrate Safety and Immunogenicity of a Commercially Available Preservative Free Inactivated Split Influenza Vaccine, Using the Strain Composition 2006/2007 When Administered to Non-Elderly Adult and Elderly Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis
Collaborators
Novartis Vaccines

4. Oversight

5. Study Description

Brief Summary
Due to antigenic changes of influenza viruses, the virus strains used in influenza vaccines are adjusted every year according to WHO (World Health Organization) and CHMP (Committee for Medicinal Products for Human Use) recommendations. Immunogenicity and tolerability of the newly composed vaccines are subject for evaluation in a yearly clinical trial in non-elderly and elderly subjects (CPMP/BWP/214/96).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
influenza, vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
125 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
preservative free inactivated split influenza vaccine using the strain composition 2006/2007
Primary Outcome Measure Information:
Title
antibody titers to each influenza strain measured by hemagglutination inhibition (HI) test on Day 0 and on Day 21
Secondary Outcome Measure Information:
Title
safety of a single IM dose of the split influenza vaccine using solicited local and systemic reactions and adverse event reporting

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy adults aged >18 years Exclusion Criteria: serious chronic diseases or significant acute infections requiring systemic antibiotic treatment history of any anaphylaxis, serious vaccine reactions hypersensitivity against vaccine components history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine known or suspected impairment/alteration of immune function more than one injection of influenza vaccine received or laboratory confirmed influenza disease within last 6 months: influenza vaccination received
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Vaccines - Drug Information Services
Organizational Affiliation
Novartis Vaccines & Diagnostics
Official's Role
Study Chair
Facility Information:
Facility Name
Werksarztzentrum Herborn, Westerwaldstr 36,
City
Herborn
ZIP/Postal Code
35745
Country
Germany
Facility Name
Betriebsarztlicher Dienst, Universitat Marburg, Robert-Koch-Str, 5,
City
Marburg
ZIP/Postal Code
35037
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

Safety and Immunogenicity of Preservative Free Inactivated Split Influenza Vaccine, Using the Strain Composition 2006/2007 in Non-Elderly Adult and Elderly Subjects

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