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NCT00518453 Clinical Trial

Immunogenicity of a Surface Antigen, Inactivated Influenza Vaccine Formulation 2007-2008

Influenza Clinical Trial

Official title:
A Phase II, Open-Label, Uncontrolled, Single Center Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated Influenza Vaccine Ph.Eur, Formulation 2007-2008, When Administered to Non-Elderly Adult and Elderly Subjects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00518453
Other study ID # V78P5S
Secondary ID 2007-002063-27
Status Completed
Phase Phase 2
First received August 17, 2007
Last updated November 30, 2016
Start date July 2007
Est. completion date August 2007

Study information
Verified date November 2011
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
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 and CPMP recommendations. Immunogenicity and tolerability of the newly composed vaccines are subject for evaluation in a yearly clinical trial in non-elderly adults and elderly subjects (CPMP/BWP/214/96).

Recruitment information / eligibility
Status Completed
Enrollment 129
Est. completion date August 2007
Est. primary completion date August 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 84 Years
Eligibility Inclusion Criteria:

- Healthy Subjects eligible for enrollment into this study are male and female adult volunteers

Exclusion Criteria:

- Any serious disease

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:
• Surface antigen inactivated influenza vaccine
1 dose of Fluvirin 2007/2008 Northern Hemisphere vaccine composition

Locations
Country Name City State
United Kingdom The Health Centre Suffolk

Sponsors (1)
Lead Sponsor Collaborator
Novartis Vaccines

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary evaluate the antibody response to each influenza vaccine antigen 21 days post-immunization No
Secondary Safety and tolerability of the study vaccine in the study population Throughout the study Yes
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