Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2006/2007) When Administered to Subjects 18 Years of Age or Older
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
2 other identifiers
interventional
100
1 country
2
Brief Summary
To evaluate the antibody response to each influenza vaccine antigen when administering a single dose to subjects aged 18 years and over
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2006
CompletedFirst Posted
Study publicly available on registry
May 25, 2006
CompletedStudy Start
First participant enrolled
June 1, 2006
CompletedSeptember 14, 2006
September 1, 2006
May 23, 2006
September 13, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
CHMP criteria for evaluation of flu vaccines e.g Seroprotection, GMR's and Seroconversion rate at day 21 following vaccination.
Secondary Outcomes (3)
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).
Interventions
Eligibility Criteria
You may qualify if:
- years of age or older
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
- Novartis Vaccinescollaborator
Study Sites (2)
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, 66100, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Novartis Vaccines - Drug Information Services
Novartis Vaccines & Diagnostics
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 23, 2006
First Posted
May 25, 2006
Study Start
June 1, 2006
Last Updated
September 14, 2006
Record last verified: 2006-09