Clinical trial NCT00329966: Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2006/2007) When Administered to Subjects 18 Years of Age or Older
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Keywords: Influenza
adult
elderly
vaccine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Novartis Vaccines
First posted: 2006-05-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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


Eligibility criteria: 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)

Primary outcomes:
measure: CHMP criteria for evaluation of flu vaccines e.g Seroprotection, GMR's and Seroconversion rate at day 21 following vaccination.
Secondary outcomes:
measure: Number and percentage of subjects with at least one local reaction between Day 0 and Day 3 after vaccine injection.
measure: Number and percentage of subjects with at least one systemic reaction between Day 0 and Day 3 after vaccine injection.
measure: Number and percentage of subjects with at least one adverse event between Day 0 and the study termination visit (Day 21, window: 20-24).
Other outcomes:
Locations:
city: Chieti
country: Italy
facility: Dipartimento di Medicina e Scienze dell'Invecchiamento Università G. D'AnnunzioVia dei Vestini
city: Lanciano
country: Italy
facility: Ufficio Igiene e Sanità Pubblica di Lanciano, ASL, Via S. Spaventa, 37
Study officials:
affiliation: Novartis Vaccines & Diagnostics
name: Novartis Vaccines - Drug Information Services
role: STUDY_CHAIR
References: