IDflu™: Split virion inactivated influenza vaccine
BiologicalSingle dose 0.1 mL, intradermal
Other names: IDflu™
NCT Number: NCT01215669
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
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 4
Seoul, South Korea
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Single dose 0.1 mL, intradermal
Other names: IDflu™
Single dose 0.5 mL, intramuscular
Other names: Vaxigrip®
Time frame: 21 days post-vaccination
Time frame: Day 0 to up to 21 days post-vaccination
Sanofi Pasteur, a Sanofi Company
Industry
Immunogenicity and Safety of Sanofi Pasteur's Intradermal Influenza Vaccine (IDflu™) in Adults and Elderly in Korea
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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