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NCT00498303 Clinical Trial

Safety and Immunogenicity of Trivalent Split Influenza Vaccine Using the Strain Composition 2007/2008

Seasonal Influenza Clinical Trial

Official title:
A Phase III, Multicenter, Uncontrolled, Open-Label Study to Evaluate Safety and Immunogenicity of Preservative Free, Inactivated Split Influenza Vaccine, Using the Strain Composition 2007/2008 When Administered to Adult and Elderly Subjects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00498303
Other study ID # V44P11S
Secondary ID 2007-001403-38
Status Completed
Phase Phase 3
First received July 9, 2007
Last updated April 21, 2008
Start date June 2007

Study information
Verified date April 2008
Source Novartis
Contact n/a
Is FDA regulated No
Health authority Germany: Paul-Ehrlich-Institute
Study type Interventional

Clinical Trial Summary

Annual trial for registration of trivalent split influenza vaccine with the strain composition of the season 2007/2008 in healthy adult and elderly subjects

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- = 18 years of age, mentally competent, willing and able to give informed consent prior to study entry

- available for all the visits scheduled in the study and able to comply with all study requirements

- in good health as determined by: medical history, physical examination, clinical judgment of the investigator

Exclusion Criteria:

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:
• trivalent split influenza vaccine

Locations
Country Name City State
Germany Werksarztzentrum Herborn Herborn

Sponsors (2)
Lead Sponsor Collaborator
Novartis Novartis Vaccines

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary evaluate the antibody response to each influenza vaccine antigen, as measured by haemagglutination inhibition (HI) test on Day 0 and on Day 21
Primary evaluate safety of trivalent split influenza vaccine
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