Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00649883 | Safety and Immunogenicity of Two 0.25 mL or 0.5 mL Doses of Two Different Influenza Vaccines in Healthy Children Aged 6 to <60 Months | PHASE2 | COMPLETED | 360 | — | — | Jan 1, 2008 | Oct 1, 2008 | Apr 7, 2017 | 5 | Guatemala |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| 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. |
| 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. |
Inclusion Criteria: * Children of 6 to \<60 months of age, whose parents/legal guardians have given written informed consent prior to study entry. * In good health as determined by: medical history, physical examination, clinical judgment of the investigator. * Able to comply with all study procedu...