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NCT00354016 Clinical Trial

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

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00354016
Other study ID # V44P10S
Secondary ID EudraCT number 2
Status Completed
Phase Phase 3
First received July 18, 2006
Last updated March 12, 2007
Start date July 2006

Study information
Verified date March 2007
Source Novartis
Contact n/a
Is FDA regulated No
Health authority Germany: Paul-Ehrlich-Institut
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 125
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Biological:
• preservative free inactivated split influenza vaccine using the strain composition 2006/2007

Locations
Country Name City State
Germany Werksarztzentrum Herborn, Westerwaldstr 36, Herborn
Germany Betriebsarztlicher Dienst, Universitat Marburg, Robert-Koch-Str, 5, Marburg

Sponsors (2)
Lead Sponsor Collaborator
Novartis Novartis Vaccines

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary antibody titers to each influenza strain measured by hemagglutination inhibition (HI) test on Day 0 and on Day 21
Secondary safety of a single IM dose of the split influenza vaccine using solicited local and systemic reactions and adverse event reporting
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