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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00192413 | Trial to Compare the Safety, Tolerability, and Efficacy of Influenza Virus Vaccine, (CAIV-T) With Inactivated, Influenza Vaccine, Trivalent, Types A & B, in Adults Aged 60 Years and Older Against Culture-confirmed Influenza | PHASE3 | COMPLETED | 3,009 | — | — | Mar 1, 2002 | Nov 1, 2002 | Mar 14, 2012 | 4 | South Africa |
| NCT00192179 | A Phase II, Trial to Assess the Safety and Tolerability of Influenza Virus Vaccine, CAIV-T in Healthy Children and Adolescents Ages 6 to Less Than 18 Years. | PHASE2 | COMPLETED | 240 | — | — | Jun 1, 2003 | Jul 1, 2003 | Mar 2, 2012 | 6 | Belgium, Poland +1 |
The criteria for obtaining nasal and throat swabs for viral culture were any one of the following: A feeling of "feverishness", An oral temperature ≥37.2ºC, Sore throat, New or increased cough, Malaise, Myalgia. Swabs for viral cultures were also obtained, if, in the opinion of the investigator, the symptom complex so warranted.
| Arm | Type | Description |
|---|---|---|
| Cold-adapted influenza vaccine trivalent (CAIV-T) | EXPERIMENTAL | A single 0.2 mL dose of 10\^7 fluorescent focus units was administered intranasally. |
| Trivalent Inactivated Vaccine (TIV) | ACTIVE_COMPARATOR | A single dose was administered by intramuscular injection. |
| CAIV-T | EXPERIMENTAL | The total volume of 0.2 ml was administered intranasally with a spray applicator (approximately 0.1 mL into each nostril). |
| Placebo | PLACEBO_COMPARATOR | The total volume of 0.2 ml was administered intranasally with a spray applicator (approximately 0.1 mL into each nostril). |
| Name | Type | Description |
|---|---|---|
| Cold-adapted influenza vaccine trivalent (CAIV-T) | BIOLOGICAL | Liquid CAIV-T vaccine for this study consisted of 3 cold-adapted, attenuated, reassortant strains, representing the HA and NA antigens of the A/New Caledonia/20/99 (H1N1), A/Panama/2007/99 (H3N2), and B/Victoria/504/2000 influenza strains. The vaccine contained no preservatives and had a pH of 7.2 ± 0.5. |
| Trivalent Inactivated Vaccine (TIV) | BIOLOGICAL | Commercially available TIV, inactivated influenza vaccine (Split Virion) BP (Aventis Pasteur MSD, Lyon, France) was administered IM according to the manufacturer's dosing instructions (one 0.5-mL IM dose for adults). |
| Placebo | BIOLOGICAL | The placebo consisted of physiologic normal saline. |
Inclusion Criteria: * who are aged at least 60 years or older at the time of enrollment; * who are determined by medical history, physical examination and clinical judgement to be eligible for this study; * who have provided written informed consent after the nature of the study has been explained;...