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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00192335 | Trial to Demonstrate Equivalent Immunogenicity of CAIV-T and FLUMIST in Healthy Participants | PHASE3 | COMPLETED | 890 | — | — | Jul 1, 2004 | Feb 1, 2005 | Nov 27, 2007 | 3 | United States |
| NCT00192400 | Trial to Assess the Safety and Tolerability of the Liquid Formulation of CAIV-T in Healthy Children. | PHASE3 | COMPLETED | 2,160 | — | — | Mar 1, 2002 | Nov 1, 2002 | Oct 3, 2006 | - | — |
| NCT00192374 | Trial to Compare the Safety, Tolerability, Immunogenicity and Efficacy of Three Dose Levels of a Liquid Formulation of Influenza Virus Vaccine, (CAIV-T) in Healthy Children | PHASE3 | COMPLETED | 1,920 | — | — | Feb 1, 2002 | Nov 1, 2002 | Oct 3, 2006 | 2 | Philippines, Thailand |
| NCT00192244 | Trial to Determine the Safety and Efficacy of Influenza Virus Vaccine, Trivalent, Types A & B, Live, Cold-Adapted (CAIV-T) in Healthy Children | PHASE3 | COMPLETED | 3,000 | — | — | Sep 1, 2000 | Oct 1, 2002 | Oct 3, 2006 | 1 | China |
| NCT00192270 | Trial to Assess Safety, Tolerability, and Immunogenicity of Influenza Virus Vaccine, Trivalent, Types A and B, Live Cold-adapted (CAIV-T) in Healthy Children | PHASE2 | COMPLETED | 498 | — | — | Oct 1, 2000 | Jan 1, 2001 | Mar 6, 2012 | 3 | Belgium, Finland |
| NCT00192348 | A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety and Tolerability of Influenza Virus Vaccine,(CAIV-T) in Healthy Infants | PHASE1 | COMPLETED | 120 | — | — | May 1, 2002 | Dec 1, 2002 | Sep 13, 2021 | 1 | Finland |
Immunogenicity was evaluated by comparison of pre and post-vaccination strain-specific titers of serum HAI antibody. Seroconversion was defined as a four-fold or greater rise in serum HAI antibody titer.
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | CAIVT-The total volume of 0.2 mL will be administered intranasally with a spray applicator (approximately 0.1 mL into each nostril). |
| 2 | ACTIVE_COMPARATOR | FluMist- The total volume of 0.5 mL will be administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). |
| Cold-adapted influenza vaccine trivalent (CAIV-T) | EXPERIMENTAL | All subjects were scheduled to receive 2 doses of CAIV-T.The total volume of 0.2 mL was administered intranasally with a spray applicator (approximately 0.1 mL into each nostril). |
| Name | Type | Description |
|---|---|---|
| CAIV-T | BIOLOGICAL | - |
| CAIVT | BIOLOGICAL | The total volume of 0.2 mL will be administered intranasally with a spray applicator (approximately 0.1 mL into each nostril). |
| FluMist | BIOLOGICAL | The total volume of 0.5 mL will be administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). |
| CAIV-T, Liquid | BIOLOGICAL | - |
Inclusion Criteria: * Age 5 through 49 years (not yet reached their 50th birthday); * In general good health; * Individual or parent/guardian available by telephone; * Ability of the participant or parent/guardian to understand and comply with the requirements of the protocol; and * Written informe...