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Egg derived influenza subunit vaccine · 1 trial · 1 indication
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...
Egg derived influenza subunit vaccine is an investigational vaccine being studied for the prevention of influenza, a contagious respiratory illness. It is designed to be administered to healthy children and adolescents aged 3 years and older. The vaccine is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
Egg derived influenza subunit vaccine is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company conducted a Phase 2 clinical trial to evaluate the vaccine's safety and immunogenicity in pediatric populations.
Egg derived influenza subunit vaccine is in Phase 2 clinical development. It is an investigational product and has not received regulatory approval. One Phase 2 trial has been completed, involving 3,604 participants, to assess the vaccine's safety and immune response in children and adolescents.
Egg derived influenza subunit vaccine has been studied in one completed Phase 2 clinical trial, registered as NCT00645411. This trial, titled 'Pediatric Safety and Immunogenicity Study of Cell-Culture Derived and Egg-based Subunit Influenza Vaccines in Healthy Children and Adolescents,' enrolled 3,604 participants across the United States, Croatia, Finland, Hungary, Italy, Lithuania, and Romania.
Egg derived influenza subunit vaccine is not the same as a cell-culture derived influenza vaccine. The Phase 2 trial NCT00645411 compared the egg-based subunit vaccine against cell-culture derived subunit influenza vaccines to evaluate their safety and immunogenicity. The egg-derived version is produced using eggs, while cell-culture versions are produced in cultured cells.