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Safety and Immunogenicity of an Intramuscular Pandemic Influenza Vaccine in Adults and the Elderly

Primary Purpose

Influenza, Orthomyxoviridae Infections

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
A/H5N1 inactivated, split-virion influenza virus
A/H5N1 inactivated, split-virion influenza virus
Sponsored by
Sanofi Pasteur, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring Influenza, Orthomyxoviridae Infections, Influenza Pandemics, A/H5N1 strain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria :

  • Aged over 18 years on the day of inclusion
  • Informed consent form signed
  • Able to attend all scheduled visits and to comply with all trial procedures
  • For a woman, inability to bear a child or negative urine pregnancy test
  • For a woman of child-bearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior and at least 4 weeks after to each vaccination.

Exclusion Criteria :

  • Systemic hypersensitivity to any component of the vaccine or a life-threatening reaction after previous administration of a vaccine containing the same substances
  • Febrile illness (oral temperature ≥ 37.5°C) on the day of inclusion
  • Breast-feeding
  • Previous vaccination with an avian flu vaccine
  • Participation in a clinical trial (drug, device, or medical procedure) within 4 weeks prior to the first vaccination
  • Planned participation in another clinical trial during the present trial period
  • Congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months or long-term systemic corticosteroid therapy
  • Chronic illness that could interfere with trial conduct or completion (e.g. cardiac, renal, diabetes, or auto-immune disorders)
  • Current alcohol or drug abuse that may interfere with the subject's ability to comply with trial procedures
  • Receipt of blood or blood-derived products within the past 3 months
  • Any vaccination within 4 weeks prior to the first trial vaccination
  • Vaccination planned within 4 weeks after any trial vaccination
  • Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination
  • Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Study Group 1

Study Group 2

Arm Description

Vaccine with adjuvant

Vaccine without adjuvant

Outcomes

Primary Outcome Measures

To provide information concerning the safety of an A/H5N1 inactivated, split-virion influenza virus vaccine

Secondary Outcome Measures

Full Information

First Posted
December 21, 2006
Last Updated
January 10, 2014
Sponsor
Sanofi Pasteur, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00415129
Brief Title
Safety and Immunogenicity of an Intramuscular Pandemic Influenza Vaccine in Adults and the Elderly
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi Pasteur, a Sanofi Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Based on the results from a previous formulation/dosage ranging trial, this phase II multicenter, open trial was designed to determine the safety and immunogenicity of two vaccine formulation/dosages with and without adjuvant 21 days after each vaccination in adults (18 to 60 years and in the elderly (> 60 years) as required by the European Medicines Agency (EMEA) guideline. The antibody persistence until the booster vaccination at 6 or 12 months will also be evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Orthomyxoviridae Infections
Keywords
Influenza, Orthomyxoviridae Infections, Influenza Pandemics, A/H5N1 strain

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Group 1
Arm Type
Experimental
Arm Description
Vaccine with adjuvant
Arm Title
Study Group 2
Arm Type
Experimental
Arm Description
Vaccine without adjuvant
Intervention Type
Biological
Intervention Name(s)
A/H5N1 inactivated, split-virion influenza virus
Intervention Description
0.5mL, Intramuscular
Intervention Type
Biological
Intervention Name(s)
A/H5N1 inactivated, split-virion influenza virus
Intervention Description
0.5mL, Intramuscular
Primary Outcome Measure Information:
Title
To provide information concerning the safety of an A/H5N1 inactivated, split-virion influenza virus vaccine
Time Frame
21 Days post-vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria : Aged over 18 years on the day of inclusion Informed consent form signed Able to attend all scheduled visits and to comply with all trial procedures For a woman, inability to bear a child or negative urine pregnancy test For a woman of child-bearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior and at least 4 weeks after to each vaccination. Exclusion Criteria : Systemic hypersensitivity to any component of the vaccine or a life-threatening reaction after previous administration of a vaccine containing the same substances Febrile illness (oral temperature ≥ 37.5°C) on the day of inclusion Breast-feeding Previous vaccination with an avian flu vaccine Participation in a clinical trial (drug, device, or medical procedure) within 4 weeks prior to the first vaccination Planned participation in another clinical trial during the present trial period Congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months or long-term systemic corticosteroid therapy Chronic illness that could interfere with trial conduct or completion (e.g. cardiac, renal, diabetes, or auto-immune disorders) Current alcohol or drug abuse that may interfere with the subject's ability to comply with trial procedures Receipt of blood or blood-derived products within the past 3 months Any vaccination within 4 weeks prior to the first trial vaccination Vaccination planned within 4 weeks after any trial vaccination Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Sanofi Pasteur Inc
Official's Role
Study Director
Facility Information:
City
Ghent
Country
Belgium
City
Leuven
Country
Belgium
City
Wilrijk
Country
Belgium
City
Oxford
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
27814377
Citation
Lazarus R, Kelly S, Snape MD, Vandermeulen C, Voysey M, Hoppenbrouwers K, Hens A, Van Damme P, Pepin S, Leroux-Roels I, Leroux-Roels G, Pollard AJ. Antibody Persistence and Booster Responses to Split-Virion H5N1 Avian Influenza Vaccine in Young and Elderly Adults. PLoS One. 2016 Nov 4;11(11):e0165384. doi: 10.1371/journal.pone.0165384. eCollection 2016.
Results Reference
derived
PubMed Identifier
19761837
Citation
Leroux-Roels I, Van der Wielen M, Kafeja F, Vandermeulen C, Lazarus R, Snape MD, John T, Carre C, Nougarede N, Pepin S, Leroux-Roels G, Hoppenbrouwers K, Pollard AJ, Van Damme P. Humoral and cellular immune responses to split-virion H5N1 influenza vaccine in young and elderly adults. Vaccine. 2009 Nov 16;27(49):6918-25. doi: 10.1016/j.vaccine.2009.08.110. Epub 2009 Sep 15.
Results Reference
derived
Links:
URL
http://www.sanofipasteur.com
Description
Related Info

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Safety and Immunogenicity of an Intramuscular Pandemic Influenza Vaccine in Adults and the Elderly

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