Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2007/2008) When Administered to NON Elderly AND Elderly Subjects
A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of an Adjuvanted Influenza Vaccine Surface Antigen, Inactivated, Formulation 2007-2008, When Administered to Non-Elderly Adult and Elderly Subjects
2 other identifiers
interventional
125
1 country
3
Brief Summary
To evaluate the antibody response to each influenza vaccine antigen when administering a single dose to subjects aged \> 18 years
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2007
Shorter than P25 for phase_2
3 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
Study Start
First participant enrolled
June 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 20, 2007
CompletedFirst Posted
Study publicly available on registry
August 21, 2007
CompletedDecember 1, 2016
November 1, 2011
1 month
August 20, 2007
November 30, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and immunogenicity of seasonal inactivated, influenza vaccine, formulation 2007-2008, when administered to non-elderly adult and elderly subjects
Study Arms (1)
Arm 1
EXPERIMENTALInterventions
seasonal influenza vaccine 15ug
Eligibility Criteria
You may qualify if:
- \> 18 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 history of neurological symptoms or signs, or anaphylactic shock following administration of any 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 fever within the past 3 days.No women in breast feeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G. D'Annunzio
Via Dei Vestini, Chieti, Italy
Ufficio Igiene e Sanità Pubblica di Lanciano, ASL Lanciano - Vasto sede legale
Via S. Spaventa, 37, Lanciano, Chieti, Italy
Presidio Distrettuale No. 8 Azienda Sanitaria USL 7 di Siena
Siena, 53100, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Novartis Vaccines
Novartis Vaccines
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2007
First Posted
August 21, 2007
Study Start
June 1, 2007
Primary Completion
July 1, 2007
Study Completion
July 1, 2007
Last Updated
December 1, 2016
Record last verified: 2011-11