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Safety and Immunogenicity of Two Adjuvanted and One Non-adjuvanted H5N1 Influenza Vaccine in Adults

Primary Purpose

Influenza

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
MF59 adjuvanted H5N1 influenza vaccine
Sponsored by
Novartis Vaccines
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring influenza, pandemic influenza, influenza vaccine, adjuvanted influenza vaccine, H5N1 influenza antigen, MF59, Pandemic influenza disease

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Presidio Distrettuale N. 8, Azienda USL 7 di Siena, Via Savina Petrilli, 3

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

MF59 adjuvant H5N1 influenza vaccine 7.5 micrograms

MF59 adjuvant H5N1 influenza vaccine 15 micrograms

non-adjuvanted influenza vaccine 15 micrograms of H5N1 antigen

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Solicited Local and Systemic Reactions Within 6 Days Following Each Vaccination And Adverse Events Throughout the Study.

Full Information

First Posted
September 27, 2006
Last Updated
November 30, 2016
Sponsor
Novartis Vaccines
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1. Study Identification

Unique Protocol Identification Number
NCT00382187
Brief Title
Safety and Immunogenicity of Two Adjuvanted and One Non-adjuvanted H5N1 Influenza Vaccine in Adults
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Vaccines

4. Oversight

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
influenza, pandemic influenza, influenza vaccine, adjuvanted influenza vaccine, H5N1 influenza antigen, MF59, Pandemic influenza disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MF59 adjuvant H5N1 influenza vaccine 7.5 micrograms
Arm Type
Experimental
Arm Title
MF59 adjuvant H5N1 influenza vaccine 15 micrograms
Arm Type
Experimental
Arm Title
non-adjuvanted influenza vaccine 15 micrograms of H5N1 antigen
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
MF59 adjuvanted H5N1 influenza vaccine
Intervention Description
MF59 adjuvanted (H5N1) influenza vaccine (Vietnam strain) containing 7.5 mg or 15 mg of H5N1 non-adjuvanted influenza vaccine containing 15 ug of H5N1
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Solicited Local and Systemic Reactions Within 6 Days Following Each Vaccination And Adverse Events Throughout the Study.
Time Frame
Day 1 to Day 382

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Vaccines - Information Services
Organizational Affiliation
Novartis
Official's Role
Study Chair
Facility Information:
Facility Name
Presidio Distrettuale N. 8, Azienda USL 7 di Siena, Via Savina Petrilli, 3
City
Siena
ZIP/Postal Code
53100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
19237568
Citation
Galli G, Medini D, Borgogni E, Zedda L, Bardelli M, Malzone C, Nuti S, Tavarini S, Sammicheli C, Hilbert AK, Brauer V, Banzhoff A, Rappuoli R, Del Giudice G, Castellino F. Adjuvanted H5N1 vaccine induces early CD4+ T cell response that predicts long-term persistence of protective antibody levels. Proc Natl Acad Sci U S A. 2009 Mar 10;106(10):3877-82. doi: 10.1073/pnas.0813390106. Epub 2009 Feb 23.
Results Reference
result

Learn more about this trial

Safety and Immunogenicity of Two Adjuvanted and One Non-adjuvanted H5N1 Influenza Vaccine in Adults

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