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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01001325 | Does Seasonal Influenza Vaccination Affect the Incidence of pH1N1 Influenza? | PHASE3 | COMPLETED | 468 | — | — | Oct 1, 2009 | Jul 1, 2010 | Apr 20, 2012 | 2 | Canada |
Influenza infection (pH1N1) as diagnosed by PCR from self-collected mid-turbinate swab. Participant is asked to collect a swab when they have symptoms possibly compatible with an acute viral respiratory illness: 1) fever without another obvious source, 2) at least two new respiratory symptoms (runny or stuffy nose, sneezing, sore or scratchy throat, hoarseness, cough), or 3) one respiratory symptom (as above) and one systemic symptom (fever, malaise, muscle aches, headache, fatigue)
| Arm | Type | Description |
|---|---|---|
| Seasonal influenza vaccination | EXPERIMENTAL | Receipt of Fluviral seasonal (2009-2010, Canadian) influenza vaccination as per manufacturers specification |
| Placebo | PLACEBO_COMPARATOR | 0.5 mL normal saline |
| Name | Type | Description |
|---|---|---|
| Fluviral influenza vaccine, 2009-2010 | BIOLOGICAL | 0.5 mL intramuscular |
| Normal saline | BIOLOGICAL | 0.5 mL intramuscular |
Inclusion Criteria: 1. 18 to 60 years old, inclusive, as of September 1st, 2009; 2. understand the study, agree to its provisions, and give written informed consent prior to entry; 3. available for follow-up during the study period; 4. have convenient access to a computer with internet access and b...