Safety and Immunogenicity of a Subunit Trivalent Nonadjuvated Influenza Study Vaccine in Adults Aged 18 Years and Above
|ClinicalTrials.gov Identifier: NCT01636102|
Recruitment Status : Completed
First Posted : July 10, 2012
Results First Posted : January 29, 2014
Last Update Posted : November 30, 2015
|Condition or disease||Intervention/treatment||Phase|
|Human Influenza||Biological: Trivalent influenza virus vaccine (TIV)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||126 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Open Label, Uncontrolled, Multicenter Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated, Influenza Vaccine (Agrippal®), Formulation 2012/2013, When Administered to Adult and Elderly Subjects|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||July 2012|
|Experimental: Arm 1||
Biological: Trivalent influenza virus vaccine (TIV)
A single 0.5 mL dose of the study vaccine supplied in prefilled syringes and administered intramuscularly in the deltoid muscle of (preferably) the non dominant arm
- Percentage of Subjects Who Achieved Seroconversion or Significant Increase in SRH Area Against Each of Three Vaccine Strains After One Vaccination of TIV [ Time Frame: Day 22 ]
Immunogenicity was measured as the percentage of subjects who achieved seroconversion or significant increase in single radial hemolysis (SRH) area, against each of three vaccine strains, three weeks after vaccination (day 22), evaluated using SRH assay.
Seroconversion or significant increase in SRH area was defined as the percentage of subjects with a negative prevaccination serum (SRH area ≤4 mm2) to a postvaccination SRH area ≥25 mm2; or a significant increase in antibody titer from a non-negative prevaccination serum, i.e., at least a 50% increase in area. The European (CHMP) criterion is met if percentage of subjects achieving seroconversion or significant increase in SRH area is >40% (≥18 years to ≤60 years) or 30% (≥61 years).
- Geometric Mean Ratio of Subjects Against Each of Three Vaccine Strains After One Vaccination of TIV [ Time Frame: Day 22 ]
Geometric mean ratio (GMR) of subjects was calculated as the ratio of postvaccination to prevaccination SRH geometric mean areas (GMAs), directed against each of three vaccine strains, three weeks after vaccination (day 22).
The CHMP criterion was met if the geometric mean increase (GMR, day 22/day 1) in SRH antibody area is >2.5 (≥18 years to ≤60 years) or >2.0 (≥61 years).
- Percentage of Subjects Who Achieved SRH Area ≥25 mm2 Against Each of Three Vaccine Strains After One Vaccination of TIV [ Time Frame: Day 1 and 22 ]
Immunogenicity was measured as the percentage of subjects achieving SRH area ≥25 mm2 against each of three vaccine strains at baseline (day 1) and three weeks after TIV vaccination (day 22).
This criterion was met according to CHMP guideline if percentage of subjects achieving SRH area ≥25 mm2 is >70% (≥18 years to ≤60) or 60% (≥61 years).
- Numbers of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 - Day 4 Postvaccination) [ Time Frame: From day 1 through day 4 postvaccination ]Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 up to and including day 4 after the TIV vaccination.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01636102
|University Hospital Ghent, Center for Vaccinology, Prof.Dr. G Leroux Roels|
|Ghent, Belgium, BC001|
|Study Chair:||Novartis Vaccines and Diagnostics||Novartis Vaccines|