Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U111111156473 | Other Identifier | WHO |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Adult Intradermal (ID) Vaccine | Experimental | Participants aged 18 to 59 years will be vaccinated with IDflu™ influenza vaccine |
|
| Group 2: Adult Intramuscular (IM) Vaccine | Active Comparator | Participants aged 18 to 59 years will be vaccinated with Vaxigrip® Influenza vaccine |
|
| Group 3: Elderly Intradermal (ID) Vaccine | Experimental | Participants aged 60 years or older will be vaccinated with IDflu™ Influenza vaccine |
|
| Group 4: Elderly Intramuscular (IM) Vaccine | Active Comparator | Participants aged 60 years or older will be vaccinated with Vaxigrip® Influenza vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IDflu™: Split virion inactivated influenza vaccine | Biological | Single dose 0.1 mL, intradermal |
|
| Measure | Description | Time Frame |
|---|---|---|
| Information concerning the immunogenicity of intradermal influenza vaccine in terms of seroprotection status (titers ≥40) using the Hemagglutination Inhibition (HAI) technique. | 21 days post-vaccination | |
| Information regarding the safety (in terms of solicited injection site and systemic reactions) post-vaccination | Day 0 to up to 21 days post-vaccination |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur SA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul | 120 752 | South Korea | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23778938 | Result | Hoon Han S, Hee Woo J, Weber F, Joo Kim W, Ran Peck K, Il Kim S, Hwa Choi Y, Myung Kim J. Immunogenicity and safety of Intanza((R))/IDflu((R)) intradermal influenza vaccine in South Korean adults: a multicenter, randomized trial. Hum Vaccin Immunother. 2013 Sep;9(9):1971-7. doi: 10.4161/hv.25295. Epub 2013 Jun 18. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Vaxigrip®: Split virion inactivated influenza vaccine | Biological | Single dose 0.5 mL, intramuscular |
|
|
| IDflu™: Split virion inactivated influenza vaccine | Biological | Single dose 0.1 mL, intradermal |
|
|
| Vaxigrip®: Split virion inactivated influenza vaccine | Biological | Single dose 0.5 mL, intramuscular |
|
|
| Seoul |
| South Korea |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C478242 | vaxigrip |
Not provided
Not provided
Not provided