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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00192426 | Trial to Evaluate the Immune Response to OPV When Administered Concomitantly With CAIV-T to Healthy Children. | PHASE3 | COMPLETED | 2,400 | — | — | Sep 1, 2001 | Dec 1, 2001 | Oct 3, 2006 | - | — |
| NCT00192231 | Trial to Investigate Immune Responses Elicited by a Liquid Formulation of Influenza Virus Vaccine,(CAIV-T) | PHASE3 | COMPLETED | 120 | — | — | Apr 1, 2001 | Jun 1, 2001 | Sep 13, 2021 | 1 | Australia |
| NCT00217230 | Trial To Assess Safety And Efficacy Of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (CAIV-T) In Adults Aged 60 Years And Older | PHASE3 | COMPLETED | 3,000 | — | — | Apr 1, 2001 | Nov 1, 2001 | Oct 3, 2006 | 1 | South Africa |
| NCT00192192 | Trial to Investigate Immune Responses Elicited by a Liquid Formulation of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold Adapted (CAIV-T) in Healthy Adults | PHASE3 | COMPLETED | 20 | — | — | Nov 1, 2000 | Dec 1, 2000 | Sep 13, 2021 | 1 | United States |
| NCT00192283 | Trial to Determine the Safety and Efficacy of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold- Adapted (CAIV-T) in Healthy Children Attending Day Care Centers | PHASE3 | COMPLETED | 2,903 | — | — | Sep 1, 2000 | May 1, 2002 | Apr 10, 2009 | 1 | Finland |
| NCT00192361 | Trial of the Safety, Transmissibility, and Phenotypic and Genotypic Stability of Influenza Virus Vaccine,(CAIV-T), in Children Who Attend Day Care. (Final Report Version 2.0) | PHASE3 | COMPLETED | 200 | — | — | Nov 1, 1999 | - | Oct 25, 2006 | 1 | Finland |
| NCT00111579 | Study to Evaluate the Immune Responses of Trivalent Cold-Adapted Influenza Vaccine (CAIV-T) Compared With (TIV) | PHASE2 | COMPLETED | 52 | — | — | May 1, 2005 | Jan 1, 2006 | Jul 24, 2008 | 5 | United States |
| NCT00192166 | Trial to Assess Safety, Efficacy, Tolerability and Immunogenicity of Influenza Virus Vaccine, Liquid Formulation (CAIV-T), Administered Concomitantly With a Combination Live, Attenuated, Mumps, Measles, and Rubella Vaccine in Healthy Children Aged 11 - 24 Months | PHASE2 | COMPLETED | 1,200 | — | — | Oct 1, 2002 | May 1, 2003 | Dec 8, 2008 | 1 | Singapore |
| NCT00192309 | Phase II Study to Investigate the Kinetics of the Immune Response Generated by Influenza Virus Vaccine. | PHASE2 | COMPLETED | 31 | — | — | Sep 1, 2001 | Dec 1, 2001 | Feb 14, 2012 | 1 | United States |
| NCT00192387 | Trial to Investigate Viral Shedding in Healthy Children Vaccinated With Vaccine Virus Liquid (CAIV-T) | PHASE2 | COMPLETED | 60 | — | — | Sep 1, 2001 | Dec 1, 2001 | Sep 13, 2021 | 1 | United States |
The geometric mean titers for each strain between Day 0 and 28 were examined.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | CAIV-T |
| 2 | PLACEBO_COMPARATOR | Placebo |
| Cold-adapted influenza vaccine (CAIVT) | EXPERIMENTAL | A single intranasal dose of 10\^7 fluorescent focus units. |
| Trivalent inactivated vaccine (TIV) | ACTIVE_COMPARATOR | A single dose of commercially available Flushield was administered intramuscularly. |
| Placebo | PLACEBO_COMPARATOR | The 0.2 mL administered intranasally. |
| Name | Type | Description |
|---|---|---|
| CAIV-T | BIOLOGICAL | - |
| Placebo | OTHER | A single dose of placebo volume of 0.2 mL was administered intranasally with the spray applicator intended for commercial use (approximately 0.1 mL into each nostril). |
| TIV | OTHER | A total vol. of 0.25 will be administered intramuscularly for each of two doeses. |
| CAIV-T, Liquid | BIOLOGICAL | - |
Inclusion Criteria: * who are aged at least 6 months and less than 36 months of age at the time of first vaccination * who have received a full primary vaccination schedule consisting of three doses of OPV in the first year of life * who are in good health as determined by medical history, physical...