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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00192322 | Trial to Investigate Immune Responses Elicited by a Liquid Formulation of Influenza Virus Vaccine (CAIV-T) in Healthy Children | PHASE2 | COMPLETED | 173 | — | — | Sep 1, 2001 | Dec 1, 2001 | Feb 17, 2012 | 2 | United States |
The immune responses were evaluated by hemagglutination inhibition assay (HAI) on serum samples.
| Arm | Type | Description |
|---|---|---|
| CAIV-T 10^5 | EXPERIMENTAL | a single intranasal 0.2 mL dose of liquid CAIV-T 10\^5 (approximately 0.1 mL into each nostril) |
| CAIVT 10^7 | EXPERIMENTAL | A single intranasal 0.2 mL dose of liquid CAIV-T 10\^7 (approximately 0.1 mL into each nostril) |
| Placebo | PLACEBO_COMPARATOR | A single intranasal 0.2 mL dose of placebo |
| Trivalent inactivated vaccine (TIV) | ACTIVE_COMPARATOR | A single intramuscular injection of commercially available vaccine |
| Name | Type | Description |
|---|---|---|
| CAIV-T 10^7 | BIOLOGICAL | a single intranasal 0.2 mL dose of liquid CAIV-T 107 (approximately 0.1 mL into each nostril) |
| CAIVT 10^5 | BIOLOGICAL | a single intranasal 0.2 mL dose of CAIV-T \<10\^5 |
| Placebo | BIOLOGICAL | a single intranasal 0.2 mL dose of placebo |
| TIV | BIOLOGICAL | commercially available TIV injected intramuscularly |
Inclusion Criteria: * children at least 6 months of age and less than 36 months of age at the time of enrollment, and in good health as determined by medical history, physical examination and clinical judgement; * whose parent/legal guardian has provided written informed consent after the nature of...