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Safety and Immunogenicity of Two Doses, Administered Three Weeks Apart, of Two(Surface Antigen Adjuvanted With MF59C.1) Influenza Vaccines in Non-Elderly Adult and Elderly Subjects

Primary Purpose

Pandemic Influenza Disease

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Influenza vaccine surface antigen adjuvanted with MF59
Sponsored by
Novartis
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pandemic Influenza Disease focused on measuring influenza, pandemic influenza, influenza vaccine, adjuvanted influenza vaccine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Inclusion Criteria: Male and female volunteers 18 years of age or older 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, infections requiring systemic antibiotic or antiviral therapy.

Sites / Locations

  • G. D'Annunzio University
  • Department of Health Sciences
  • ASL Lanciano-Vasto
  • University Hospital of Siena

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 Thought the Study.

Full Information

First Posted
April 4, 2006
Last Updated
March 12, 2007
Sponsor
Novartis
Collaborators
Novartis Vaccines
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1. Study Identification

Unique Protocol Identification Number
NCT00311480
Brief Title
Safety and Immunogenicity of Two Doses, Administered Three Weeks Apart, of Two(Surface Antigen Adjuvanted With MF59C.1) Influenza Vaccines in Non-Elderly Adult and Elderly Subjects
Official Title
A Phase II, Randomized, Controlled, Observer-Blind, Multi-Center Study to Evaluate Safety and Immunogenicity of Two Doses, Administered Three Weeks Apart, of Two (Surface Antigen Adjuvanted With MF59C.1) Influenza Vaccines Containing 7.5 mg or 15 mg of H5N1 Influenza Antigen, in Non-Elderly Adult and Elderly Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis
Collaborators
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, of two influenza vaccines containing 7.5 micrograms or 15 micrograms of H5N1 influenza antigen, in non-elderly adult and elderly subjects.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
520 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Influenza vaccine surface antigen adjuvanted with MF59
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
Secondary Outcome Measure Information:
Title
Solicited Local and Systemic Reactions Within 6 Days Following Each Vaccination And Adverse Events Thought the Study.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria: Male and female volunteers 18 years of age or older 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, infections requiring systemic antibiotic or antiviral therapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Drug Information Services
Organizational Affiliation
Novartis Vaccines & Diagnostics
Official's Role
Principal Investigator
Facility Information:
Facility Name
G. D'Annunzio University
City
Chieti
ZIP/Postal Code
66100
Country
Italy
Facility Name
Department of Health Sciences
City
Genoa
ZIP/Postal Code
16129
Country
Italy
Facility Name
ASL Lanciano-Vasto
City
Lanciano
ZIP/Postal Code
66034
Country
Italy
Facility Name
University Hospital of Siena
City
Siena
ZIP/Postal Code
53100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
19197383
Citation
Banzhoff A, Gasparini R, Laghi-Pasini F, Staniscia T, Durando P, Montomoli E, Capecchi PL, di Giovanni P, Sticchi L, Gentile C, Hilbert A, Brauer V, Tilman S, Podda A. MF59-adjuvanted H5N1 vaccine induces immunologic memory and heterotypic antibody responses in non-elderly and elderly adults. PLoS One. 2009;4(2):e4384. doi: 10.1371/journal.pone.0004384. Epub 2009 Feb 6. Erratum In: PLoS ONE. 2009;4(3). doi: 10.1371/annotation/5f2ae0fb-53f1-48c2-aa19-9114765ba029. Capecchi, Pamela [corrected to Capecchi, Pier Leopoldo].
Results Reference
derived

Learn more about this trial

Safety and Immunogenicity of Two Doses, Administered Three Weeks Apart, of Two(Surface Antigen Adjuvanted With MF59C.1) Influenza Vaccines in Non-Elderly Adult and Elderly Subjects

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