- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01215669
Study of Sanofi Pasteur's Intradermal Influenza Vaccine (IDflu™) in Adults and Elderly in Korea
September 11, 2018 updated by: Sanofi Pasteur, a Sanofi Company
Immunogenicity and Safety of Sanofi Pasteur's Intradermal Influenza Vaccine (IDflu™) in Adults and Elderly in Korea
This study is designed to assess the immunogenicity and safety of the 2010-2011 NH season formulation of intradermal (ID) influenza vaccine as part of a post registration commitment.
Objectives:
- For all groups, to evaluate compliance, in terms of immunogenicity, of the corresponding strength of the intradermal (ID) or intramuscular (IM) influenza vaccine Northern Hemisphere (NH) 2010 2011 formulation with the requirements of the Committee for Human Medicinal Products (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96
- For all groups, to describe the safety
Study Overview
Status
Completed
Conditions
Detailed Description
All participants will receive a single dose of study vaccine on Day 0. Immunogenicity data will be collected before vaccination and on Day 21 post vaccination.
Safety will be assessed throughout the study.
Study Type
Interventional
Enrollment (Actual)
240
Phase
- Phase 4
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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Seoul, Korea, Republic of
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Seoul, Korea, Republic of, 120 752
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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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Aged 18 years and 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.
Exclusion Criteria:
- 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 seasonal influenza vaccination within the previous 6 months (other than pandemic H1N1 influenza vaccine)
- Receipt of an influenza vaccine (either seasonal or pandemic 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, under the investigator's judgment
- 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 department, with direct involvement in the proposed study or other studies under the direction of that Investigator or study department as well as family members (i.e., immediate, husband, wife and their children, adopted or natural) of the employees or the Investigator
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Group 1: Adult Intradermal (ID) Vaccine
Participants aged 18 to 59 years will be vaccinated with IDflu™ influenza vaccine
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Single dose 0.1 mL, intradermal
Other Names:
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Active Comparator: Group 2: Adult Intramuscular (IM) Vaccine
Participants aged 18 to 59 years will be vaccinated with Vaxigrip® Influenza vaccine
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Single dose 0.5 mL, intramuscular
Other Names:
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Experimental: Group 3: Elderly Intradermal (ID) Vaccine
Participants aged 60 years or older will be vaccinated with IDflu™ Influenza vaccine
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Single dose 0.1 mL, intradermal
Other Names:
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Active Comparator: Group 4: Elderly Intramuscular (IM) Vaccine
Participants aged 60 years or older will be vaccinated with Vaxigrip® Influenza vaccine
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Single dose 0.5 mL, intramuscular
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Information concerning the immunogenicity of intradermal influenza vaccine in terms of seroprotection status (titers ≥40) using the Hemagglutination Inhibition (HAI) technique.
Time Frame: 21 days post-vaccination
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21 days post-vaccination
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Information regarding the safety (in terms of solicited injection site and systemic reactions) post-vaccination
Time Frame: Day 0 to up to 21 days post-vaccination
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Day 0 to up to 21 days post-vaccination
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
October 1, 2010
Primary Completion (Actual)
February 1, 2011
Study Completion (Actual)
April 1, 2011
Study Registration Dates
First Submitted
October 5, 2010
First Submitted That Met QC Criteria
October 5, 2010
First Posted (Estimate)
October 6, 2010
Study Record Updates
Last Update Posted (Actual)
September 13, 2018
Last Update Submitted That Met QC Criteria
September 11, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GID33
- U111111156473 (Other Identifier: WHO)
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.
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