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| Name | Class |
|---|---|
| Novartis Vaccines | INDUSTRY |
This a multicenter phase II trial will evaluate safety and immunogenicity of two 0.25 mL or 0.5 mL doses of investigational influenza vaccine and active control influenza vaccine in healthy children aged 6 to <60 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza Trivalent Inactivated vaccines Novartis | Biological | Children 6 to <36 months of age will receive two 0.25 mL doses, and children 36 to <60 months of age will receive two 0.5 mL doses of investigational influenza vaccine, administered four weeks apart intramuscularly (IM) in the deltoid muscle preferably of the non-dominant arm. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability of one and two doses of investigational vaccines or active control influenza vaccine in unprimed healthy children aged 6 months to <36 months. | 211 days |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the immunogenicity of two doses of investigational influenza vaccine or active control influenza vaccines, as measured by HI assay in children aged 36 to <60 months. | 211 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Clínico La Quinta | Guatemala City | Guatemala City | Guatemala | |||
| Clínicas Dr. Rafael Montiel |
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|
| Influenza Trivalent Inactivated vaccines | Biological | Children 6 to <36 months of age will receive two 0.25 mL doses, and children 36 to <60 months of age will receive two 0.5 mL doses of active control influenza vaccine, administered four weeks apart intramuscularly (IM) in the deltoid muscle preferably of the non-dominant arm. |
|
| Guatemala City |
| Guatemala City |
| Guatemala |
| Dr. Carlos Fernando Grazioso Aragón | Guatemala City | Guatemala City | Guatemala |
| Fundación Pediátrica Guatemalteca | Guatemala City | Guatemala City | Guatemala |
| Hospital Infantil de Infectologia y rehabilitacion | Guatemala City | Guatemala City | Guatemala |
| 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 |
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