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
Not provided
Not provided
This study is part of an effort to develop an effective vaccination program in children in the event of a pandemic.
Study objectives:
Study participants will receive two administrations of the investigational vaccine at one of 3 vaccination schedules.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Participants on vaccination schedule 1 (Day 0 and Day 21) |
|
| Group 2 | Experimental | Participants on vaccination schedule 2 (Day 0 and Day 14) |
|
| Group 3 | Experimental | Participants on vaccination schedule 3 (Day 0 and Day 42) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine | Biological | 0.5 mL, Intramuscular |
|
| Measure | Description | Time Frame |
|---|---|---|
| To provide information concerning the safety of the Split Virion Pandemic Influenza vaccine. | 21 days post-vaccination and entire study |
| Measure | Description | Time Frame |
|---|---|---|
| To provide information concerning the immunogenicity of Split Virion Pandemic Influenza vaccine. | 21 days post-vaccination |
Not provided
Inclusion Criteria :
All Subjects
Subjects Aged ≥ 2 Years to < 18 Years:
Subjects Aged ≥ 6 Months to < 2 Years:
Exclusion Criteria :
All subjects
Subjects Aged ≥2 Years to <18 Years:
Subjects Aged ≥ 6 Months to < 2 Years:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Sanofi Pasteur Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Espoo | FIN-02100 | Finland | ||||
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Helsinki |
| FIN-00100 |
| Finland |
| Helsinki | FIN-00930 | Finland |
| Jarvenpaa | FIN-04400 | Finland |
| Kuopio | FIN-70100 | Finland |
| Lahti | FIN-15140 | Finland |
| Oulu | FIN-90220 | Finland |
| Pori | FIN-28100 | Finland |
| Tampere | FIN-33014 | Finland |
| Tampere | FIN-33100 | Finland |
| Turku | FIN-20520 | Finland |
| Vantaa | FIN-01300 | Finland |
| Vantaa | FIN-01600 | Finland |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D009976 | Orthomyxoviridae Infections |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided