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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00885105 | Evaluation of Responses to Fluzone® in Infants ≥ 6 Months of Age Who Did or Did Not Receive Fluzone® at 2 Months of Age | PHASE3 | COMPLETED | 242 | — | — | Oct 1, 2005 | Sep 1, 2007 | Apr 14, 2016 | 6 | United States |
| NCT00845429 | Immunogenicity of a Split, Cell-Based, Inactivated, Trivalent Influenza Vaccine in Healthy Adult Subjects | PHASE2 | COMPLETED | 729 | — | — | Oct 1, 2007 | Nov 1, 2008 | Dec 19, 2012 | 15 | United States |
| NCT00858468 | Safety and Immunogenicity Testing of Influenza Vaccine in Healthy Children 2 Months and 6 Months of Age | PHASE1 | COMPLETED | 394 | — | — | Apr 1, 2005 | Dec 1, 2006 | Apr 14, 2016 | 8 | United States |
Seroprotection was defined as a Reciprocal Hemagglutination Inhibition Titers of ≥ 40 Post-vaccination with Fluzone® Vaccine.
Seroprotection was defined as a titer ≥ 40 1/dil, and determined in participants with a valid serology result for the particular Flu strain, including results reported as less than lower limit of quantitation (LLOQ)
Seroconversion: For participants with a Day 0 pre-vaccination titer \< 10 (1/dil), titer ≥ 40 (1/dil) on Day 21. Significant Increase: For participants with a Day 0 pre-vaccination titer ≥ 10 (1/dil), ≥ 4-fold increase of titer on Day 21.
Solicited local (injection site) reactions: Tenderness, erythema (redness), and swelling Solicited systemic reactions: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Loss of Appetite, and Irritability.
| Arm | Type | Description |
|---|---|---|
| Fluzone® Vaccine-Primed Group | EXPERIMENTAL | Participants received 2 doses of Fluzone® vaccine at 2 months (in Study GRC 27) |
| Influenza Vaccine-Naive Group | ACTIVE_COMPARATOR | Participants who have never received influenza vaccine (and not in Study GRC27) |
| Group 1: Standard-dose Cell-based Influenza Vaccine | EXPERIMENTAL | Participants will receive a single dose of standard-dose cell-based influenza virus vaccine. |
| Group 2: High-dose Cell-based Influenza Vaccine | EXPERIMENTAL | Participants will receive a single dose of high-dose cell-based influenza virus vaccine. |
| Group 3: Licensed Fluzone® Influenza Vaccine | ACTIVE_COMPARATOR | Participants will receive a single dose of licensed Fluzone® influenza vaccine. |
| Group 1 | EXPERIMENTAL | Participants aged 6 to 12 Weeks at enrollment |
| Group 2 | EXPERIMENTAL | Participants aged 24 to 36 Weeks at enrollment |
| Name | Type | Description |
|---|---|---|
| Influenza Virus Vaccine | BIOLOGICAL | 0.25 mL, Intramuscular |
| Influenza virus vaccine - cell based (2007-2008 Formulation) | BIOLOGICAL | 0.5 mL, Intramuscular |
| Influenza virus vaccine - cell-based (2007-2008 Formulation) | BIOLOGICAL | 1.0 mL, Intramuscular |
| Influenza virus vaccine (2007-2008 Formulation) | BIOLOGICAL | 0.5 mL, Intramuscular |
| Influenza virus vaccine (2004-2005 Formulation) | BIOLOGICAL | 0.25 mL, Intramuscular |
Inclusion Criteria: * Participant is between 6 and 10 months of age on the day of inclusion (has reached 6-month but has not reached 11-month anniversary of birth). * Available for the duration of the study. * Born at full term of pregnancy (≥ 36 weeks) with a birth weight ≥ 2.5 kg * Parent/legal a...