Safety and Immunogenicity of a Trivalent Influenza Vaccine When Administered to Elderly Subjects
|ClinicalTrials.gov Identifier: NCT01651104|
Recruitment Status : Completed
First Posted : July 26, 2012
Results First Posted : January 27, 2014
Last Update Posted : April 21, 2014
|Condition or disease||Intervention/treatment||Phase|
|Human Influenza||Biological: Adjuvanted Trivalent Influenza Virus Vaccine (aTIV)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||63 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2, Open Label, Uncontrolled, Multicenter Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated, Adjuvanted With MF59C.1 Influenza Vaccine (Fluad®), Formulation 2012/2013, When Administered to Elderly Subjects|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||August 2012|
|Experimental: Adjuvanted Trivalent Influenza Virus Vaccine||
Biological: Adjuvanted Trivalent Influenza Virus Vaccine (aTIV)
A single 0.5 mL dose of study vaccine supplied in prefilled syringes was administered intramuscularly in the deltoid muscle, preferably of the non dominant arm.
- Percentages of Subjects Who Achieved Seroconversion or Significant Increase in SRH Area Against Each of Three Vaccine Strains After One Vaccination of aTIV [ 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 30% (≥65 years).
- Geometric Mean Ratio of Subjects Against Each of Three Vaccine Strains After One Vaccination of aTIV [ 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 >2.0 (≥65 years).
- Percentages of Subjects Who Achieved SRH Area ≥25 mm2 Against Each of Three Vaccine Strains After One Vaccination of aTIV [ 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 aTIV vaccination (day 22).
This criterion is met according to CHMP guideline if percentage of subjects achieving SRH area ≥25 mm2 is 60% (≥65 years).
- Number 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 aTIV vaccination.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01651104
|University Hospital Ghent Center for Vaccinology|
|De Pintelaan, BE-9000 Ghent, Belgium, 185|
|Study Chair:||Novartis Vaccines and Diagnostics||Novartis Vaccines|