Safety and Immunogenicity of Two Adjuvanted and One Non-adjuvanted H5N1 Influenza Vaccine in Adults
November 30, 2016 updated by: Novartis Vaccines
A Phase II, Randomized, Controlled, Observer-blind, Single-Center Study to Evaluate Safety and Immunogenicity of Two Doses, Administered Three Weeks Apart, and a Six Month Booster Dose of Two Surface Antigen Adjuvanted With MF59C.1 Influenza Vaccines Containing 7.5 Micrograms or 15 Micrograms of A/H5N1 Influenza Antigen and of a Non-adjuvanted Influenza Vaccine Containing 15 Micrograms of A/H5N1 Influenza Antigen, in Adults
The present study aims to evaluate safety and immunogenicity of two doses, administered three weeks apart, and a 6 month booster dose, of two influenza vaccines containing 7.5 micrograms or 15 micrograms of H5N1 influenza antigen, and of a non-adjuvanted influenza vaccine containing 15 micrograms of H5N1 influenza antigen, in adults
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Siena, Italy, 53100
- Presidio Distrettuale N. 8, Azienda USL 7 di Siena, Via Savina Petrilli, 3
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male and female volunteers 18-60 years of age
Exclusion Criteria:
- Any auto-immune disease or other serious acute, chronic or progressive disease
- 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
- Within the past 7 days, they have experienced any acute disease or infections requiring systemic antibiotic or antiviral therapy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: MF59 adjuvant H5N1 influenza vaccine 7.5 micrograms
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Experimental: MF59 adjuvant H5N1 influenza vaccine 15 micrograms
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Experimental: non-adjuvanted influenza vaccine 15 micrograms of H5N1 antigen
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
CPMP criteria for evaluation of flu vaccines e.g. Seroprotection, GMT's and Seroconversion rate at day 0 and day 22 and day 43 following vaccination.
Time Frame: day 1 to day 43
|
day 1 to day 43
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Solicited Local and Systemic Reactions Within 6 Days Following Each Vaccination And Adverse Events Throughout the Study.
Time Frame: Day 1 to Day 382
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Day 1 to Day 382
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Novartis Vaccines - Information Services, Novartis
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2006
Primary Completion (Actual)
January 1, 2008
Study Completion (Actual)
January 1, 2008
Study Registration Dates
First Submitted
September 27, 2006
First Submitted That Met QC Criteria
September 27, 2006
First Posted (Estimate)
September 28, 2006
Study Record Updates
Last Update Posted (Estimate)
December 1, 2016
Last Update Submitted That Met QC Criteria
November 30, 2016
Last Verified
February 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- V87P2
- Eudract number 2006-004063-66
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.