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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00623181 | Study to Determine a Preference for Fluzone Vaccine Given Intradermally (ID) and Intramuscularly (IM) in Healthy Adults | PHASE2 | COMPLETED | 110 | — | — | Jan 1, 2008 | Jun 1, 2008 | Apr 14, 2016 | 2 | United States |
Pain or other discomfort was assessed on a scale of 0 to 10 (None = 0; Hardly Any = 1, 2; Mild = 3, 4; Moderate = 5, 6; Severe = 7, 8; Unbearable = 9, 10) according to route of administration: intradermal (ID) as Group 1 and intramuscular (IM) as Group 2. Data for this outcome were combined for responses following a similar type of vaccination route in the entire study population.
Numerical scores were assigned to pain by participants on the preference questionnaire as: None = 0; Hardly Any = 1, 2; Mild = 3, 4; Moderate = 5, 6; Severe = 7, 8; or Unbearable = 9, 10. Data for this outcome were combined for responses following a similar type of vaccination route in the entire study population.
| Arm | Type | Description |
|---|---|---|
| Fluzone Intradermal First, Then Fluzone Intramuscular | EXPERIMENTAL | - |
| Fluzone Intramuscular First, Then Fluzone Intradermal | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Fluzone: Influenza virus vaccine | BIOLOGICAL | 0.1 mL, Intradermal Right deltoid, 0.5 mL, Intramuscular Left deltoid |
Inclusion Criteria: * Healthy male or female subject (can have underlying medical condition, as long as they are stable), greater than or equal to 18 to \< 50 years of age on the day of inclusion. * Informed consent form signed. * Able to attend both scheduled visits and to comply with all trial pr...