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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00645411 | Pediatric Safety and Immunogenicity Study of Cell-Culture Derived and Egg-based Subunit Influenza Vaccines in Healthy Children and Adolescents | PHASE2 | COMPLETED | 3,604 | — | — | Oct 1, 2007 | Jul 1, 2008 | Nov 23, 2015 | 60 | United States, Croatia +5 |
To demonstrate non-inferiority of the post vaccination hemagglutination inhibition (HI) geometric mean titer (GMT) of the cell culture-derived influenza (cTIV) vaccine to the corresponding GMT of the egg-derived (eTIV) influenza vaccine, for all three strains, after two injections administered four weeks apart to a subset of children 3 to 8 years of age. GMTs were evaluated using two assays, HI egg derived antigen assay and HI cell derived antigen assay.
To demonstrate non-inferiority of the cell culture-derived influenza (cTIV) vaccine to the egg-derived (eTIV) influenza vaccine in the percentage of subjects achieving seroconversion or significant increase in antibody titer post vaccination, for all three strains, after two injections administered four weeks apart in children 3 to 8 years of age. Seroconversion rate was evaluated using two assays- HI egg derived antigen assay and HI cell derived antigen assay.
| Arm | Type | Description |
|---|---|---|
| Cohorts 1 + Cohort 2 (9-17 Yrs) cTIV | EXPERIMENTAL | All subjects received one 0.5 mL IM injection, of cell culture-derived trivalent influenza vaccine containing 15μg of HA for each strain (A/Solomon Islands/3/2006 \[H1N1\]-like, A/Wisconsin/67/2005 \[H3N2\]-like, and B/Malaysia/ 2506/2004-like), recommended for the 2007-2008 influenza season in the Northern Hemisphere |
| Cohorts 1 + Cohort 2 (9-17 Yrs) eTIV | ACTIVE_COMPARATOR | All subjects received one 0.5 mL injection, of egg -derived trivalent influenza vaccine containing 15μg of HA for each strain (A/Solomon Islands/3/2006 \[H1N1\]-like, A/Wisconsin/67/2005 \[H3N2\]-like and B/Malaysia/ 2506/2004-like), recommended for the 2007-2008 influenza season in the Northern Hemisphere. |
| Cohort 3 (3-8 Yrs) cTIV | EXPERIMENTAL | All subjects received two 0.5 mL injections, administered four weeks apart, of cell culture-derived trivalent influenza vaccine containing 15μg of HA for each strain (A/Solomon Islands/3/2006 \[H1N1\]-like, A/Wisconsin/67/2005 \[H3N2\]-like and B/Malaysia/ 2506/2004-like), recommended for the 2007-2008 influenza season in the Northern Hemisphere |
| Cohort 3 (3-8 Yrs) eTIV | ACTIVE_COMPARATOR | All subjects received two 0.5 mL injections, administered four weeks apart of egg -derived trivalent influenza vaccine containing 15μg of HA for each strain (A/Solomon Islands/3/2006 \[H1N1\]-like, A/Wisconsin/67/2005 \[H3N2\]-like and B/Malaysia/ 2506/2004-like), recommended for the 2007-2008 influenza season in the Northern Hemisphere |
| Name | Type | Description |
|---|---|---|
| Cell culture-derived influenza subunit vaccine (cTIV) | BIOLOGICAL | One 0.5 ml injection of the cell culture-derived influenza vaccine in the deltoid muscle, preferably of the nondominant arm. |
| Egg derived influenza subunit vaccine (eTIV) | BIOLOGICAL | One 0.5 ml injection of the conventional egg-derived influenza vaccine in the deltoid muscle, preferably of the nondominant arm. |
Inclusion Criteria: 1. Subjects aged 9 to 17 years (Cohorts 1 and 2) and 3 to 8 years (Cohort 3), whose parents/legal guardians have given written informed consent prior to study entry. Assent will be obtained from subjects according to age requirements of the ECs/IRBs; 2. In good health as determi...