Immunogenicity and Safety of a Vaccine Against Influenza (2010-2011 Northern Hemisphere Season, Intramuscular Route)
Primary Purpose
Influenza
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Influenza virus vaccine (split virion, inactivated)
Influenza virus vaccine (split virion, inactivated)
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring Influenza, Influenza vaccine, Influenza virus, Intramuscular
Eligibility Criteria
Inclusion Criteria :
- Aged 18 years or over on the day of inclusion
- Informed consent form has been signed and dated
- Able to attend all scheduled visits and to comply with all trial procedures
- For a woman of childbearing potential, use of an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination
- Entitled to national social security.
Exclusion Criteria :
- Febrile illness (temperature ≥ 38.0°C) or moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination
- Known systemic hypersensitivity to eggs, chicken proteins, neomycin, formaldehyde and octoxynol-9, or to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances
- Known pregnancy, or a positive urine pregnancy test
- Currently breastfeeding a child
- History of pandemic H1N1 influenza vaccination
- History of clinically or laboratory confirmed pandemic H1N1 influenza infection
- History of influenza vaccination within the previous 6 months (other than pandemic H1N1 influenza vaccine)
- Receipt of an adjuvanted influenza vaccine in a clinical trial within the previous 12 months
Known or suspected congenital or acquired immunodeficiency, resulting for example from:
- End-stage renal disease requiring dialysis
- Active neoplastic disease or active hematologic malignancy
- Receipt of immunosuppressive therapy or other immune-modifying drugs such as, but not limited to: anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- History of seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C
- Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
- History of thrombocytopenia, contraindicating intramuscular (IM) vaccination
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination
- Receipt of any vaccine in the 4 weeks preceding the trial vaccination
- Planned receipt of any vaccine in the 3 weeks following the trial vaccination
- Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial vaccination
- Planned participation in another clinical trial during the present trial period
- Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
- Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures
- Identified as employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members (i.e., immediate, husband, wife and their children, adopted or natural) of the employees or the Investigator.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group 1
Group 2
Arm Description
Participants at age 18 to 59 years
Participants at age 60 years or older
Outcomes
Primary Outcome Measures
To provide information concerning the immunogenicity of the Influenza virus vaccine (Split Virion, Inactivated), Northern Hemisphere 2010-2011 Formulation.
Safety: To provide information concerning the safety of the Influenza virus vaccine (Split Virion, Inactivated), Northern Hemisphere 2010-2011 Formulation.
Secondary Outcome Measures
Full Information
NCT ID
NCT01121822
First Posted
May 10, 2010
Last Updated
October 5, 2015
Sponsor
Sanofi Pasteur, a Sanofi Company
1. Study Identification
Unique Protocol Identification Number
NCT01121822
Brief Title
Immunogenicity and Safety of a Vaccine Against Influenza (2010-2011 Northern Hemisphere Season, Intramuscular Route)
Official Title
Immunogenicity and Safety of the Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2010-2011 Formulation (Intramuscular Route)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (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
The aim of this study is to evaluate the new formulation of the influenza vaccine for the 2010-2011 Northern Hemisphere (NH) season in terms of immunogenicity and safety in the corresponding population and to check its compliance with the Committee for Proprietary Medicinal Products (CPMP) Note for Guidance (NfG) CPMP/BWP/214/96
Objectives:
To evaluate the compliance, in terms of immunogenicity, of the influenza vaccine (split virion, inactivated) NH 2010-2011 formulation with the requirements of the Committee for Proprietary Medicinal Products (CPMP) Note for Guidance (NfG) CPMP/BWP/214/96 in both age groups
To describe the safety of the influenza vaccine (split virion, inactivated) NH 2010-2011 formulation in both age groups
Detailed Description
Each participant will receive a dose of vaccine on Day 0 and will be followed up for 21 days post-vaccination.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza, Influenza vaccine, Influenza virus, Intramuscular
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
129 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
Participants at age 18 to 59 years
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Participants at age 60 years or older
Intervention Type
Biological
Intervention Name(s)
Influenza virus vaccine (split virion, inactivated)
Intervention Description
0.5 mL, Intramuscular
Intervention Type
Biological
Intervention Name(s)
Influenza virus vaccine (split virion, inactivated)
Intervention Description
0.5 mL, Intramuscular
Primary Outcome Measure Information:
Title
To provide information concerning the immunogenicity of the Influenza virus vaccine (Split Virion, Inactivated), Northern Hemisphere 2010-2011 Formulation.
Time Frame
21 days post-vaccination
Title
Safety: To provide information concerning the safety of the Influenza virus vaccine (Split Virion, Inactivated), Northern Hemisphere 2010-2011 Formulation.
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 18 years or over on the day of inclusion
Informed consent form has been signed and dated
Able to attend all scheduled visits and to comply with all trial procedures
For a woman of childbearing potential, use of an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination
Entitled to national social security.
Exclusion Criteria :
Febrile illness (temperature ≥ 38.0°C) or moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination
Known systemic hypersensitivity to eggs, chicken proteins, neomycin, formaldehyde and octoxynol-9, or to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances
Known pregnancy, or a positive urine pregnancy test
Currently breastfeeding a child
History of pandemic H1N1 influenza vaccination
History of clinically or laboratory confirmed pandemic H1N1 influenza infection
History of influenza vaccination within the previous 6 months (other than pandemic H1N1 influenza vaccine)
Receipt of an adjuvanted influenza vaccine in a clinical trial within the previous 12 months
Known or suspected congenital or acquired immunodeficiency, resulting for example from:
End-stage renal disease requiring dialysis
Active neoplastic disease or active hematologic malignancy
Receipt of immunosuppressive therapy or other immune-modifying drugs such as, but not limited to: anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
History of seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C
Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
History of thrombocytopenia, contraindicating intramuscular (IM) vaccination
Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination
Receipt of any vaccine in the 4 weeks preceding the trial vaccination
Planned receipt of any vaccine in the 3 weeks following the trial vaccination
Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial vaccination
Planned participation in another clinical trial during the present trial period
Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures
Identified as employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members (i.e., immediate, husband, wife and their children, adopted or natural) of the employees or the Investigator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Sanofi Pasteur Inc.
Official's Role
Study Director
Facility Information:
City
Gieres
ZIP/Postal Code
38610
Country
France
City
MONTPELLIER Cedex 5
ZIP/Postal Code
34094
Country
France
City
Rouffach
ZIP/Postal Code
68250
Country
France
12. IPD Sharing Statement
Links:
URL
http://www.sanofipasteur.com
Description
Related Info
Learn more about this trial
Immunogenicity and Safety of a Vaccine Against Influenza (2010-2011 Northern Hemisphere Season, Intramuscular Route)
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