Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2006/2007) When Administered to Subjects 18 Years of Age or Older

NCT00329966 — Phase 2, Completed, 100 participants, Novartis

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A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of a Commercially Available Surface Antigen, Inactivated, Influenza Vaccine, Formulation 2006-2007, When Administered to Non-Elderly Adult and Elderly Subjects

Registry	NCT00329966
Status	Completed
Phase	Phase 2
Study type	Interventional; non randomized, single group, masking: none, prevention
Enrollment	100
Sponsor	Novartis (Industry); collaborators: Novartis Vaccines
Conditions	Influenza
Interventions	Surface Antigen, Inactivated, Influenza (form.2006-07) (Biological)
Dates	start 2006-06-01, first posted 2006-05-25, last updated 2006-09-14
Locations	2 sites in Italy

-Summary

To evaluate the antibody response to each influenza vaccine antigen when administering a single dose to subjects aged 18 years and over

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+Arms and interventions

Surface Antigen, Inactivated, Influenza (form.2006-07) (Biological)

+Outcome measures

Primary outcomes

CHMP criteria for evaluation of flu vaccines e.g Seroprotection, GMR's and Seroconversion rate at day 21 following vaccination.

Secondary outcomes

Number and percentage of subjects with at least one local reaction between Day 0 and Day 3 after vaccine injection.
Number and percentage of subjects with at least one systemic reaction between Day 0 and Day 3 after vaccine injection.
Number and percentage of subjects with at least one adverse event between Day 0 and the study termination visit (Day 21, window: 20-24).

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* 18 years of age or older

Exclusion Criteria:

* any serious disease such as cancer, autoimmune disease, advanced arteriosclerotic disease or complicated diabetes mellitus, chronic obstructive pulmonary disease (COPD) that requires oxygen therapy, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure and bleeding diathesis or conditions associated with prolonged bleeding time
* hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine known or suspected (or high risk of developing) impairment/alteration of
* immune function within the past 7 days any acute disease or infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis was acceptable)
* fever within the past 3 days
* history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine
* within the past 12 months have received more than one injection of influenza vaccine
* Women who are pregnant or women able to bear children but not willing to practice acceptable contraception for the duration of the trial (21 days)

+Locations (2)

Facility	City	Country	Status
Ufficio Igiene e Sanità Pubblica di Lanciano, ASL, Via S. Spaventa, 37	Lanciano, Lanciano	Italy
Dipartimento di Medicina e Scienze dell'Invecchiamento Università G. D'AnnunzioVia dei Vestini	Chieti	Italy

+Investigators

Novartis Vaccines - Drug Information Services, Study chair, Novartis Vaccines & Diagnostics