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

Novartis

Status and phase: Completed; Phase 2

Conditions: Influenza

Treatments: Biological: Surface antigen inactivated influenza vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00518453

2007-002063-27

V78P5S

Details and patient eligibility

About

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).

Enrollment: 129 patients

Sex: All

Ages: 18 to 84 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Any serious disease

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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129 participants in 1 patient group

Arm 1: Fluvirin

Experimental group

Treatment:

Biological: Surface antigen inactivated influenza vaccine