To assess immunogenicity of a single intramuscular injection of Fluval AB suspension for injection (trivalent, seasonal influenza vaccine, active ingredient content: 15 μgHA/0.5mL of seasonal A/H1N1, A/H3N2 and B influenza antigens each), as measured by haemagglutination inhibition (HI) test.
Aim of the study: To assess immunogenicity and safety of Fluval AB seasonal influenza vaccine with 3 x 15 μgHA active ingredient in two age groups (18-59 years and ≥60 years) in accordance with CPMP/BWP/214/96: "Note for Guidance on Harmonization of Requirements for Influenza Vaccines", 12 March 1997 Primary objective: To assess immunogenicity of a single intramuscular injection of Fluval AB suspension for injection (trivalent, seasonal influenza vaccine, active ingredient content: 15 μgHA/0.5mL of seasonal A/H1N1, A/H3N2 and B influenza antigens each), as measured by haemagglutination inhibition test. Methods: In this open label, uncontrolled, multi-centre immunogenicity and tolerability study subjects were enrolled in two groups according to age (18-59 years and ≥60 years) and assigned to the following vaccine group: Group 1: Single injection of Fluval AB suspension for injection. Subjects were observed for 30 minutes after the injection on Visit 1 (Day 0) for any immediate reactions. All subjects were requested to complete a diary card to record local reactions (injection site pain, erythema, swelling, induration and ecchymosis) and systemic reactions (fever, shivering, headache, malaise, fatigue, sweating, nausea, myalgia and arthralgia) started on the day of vaccination on Visit 1 (Day 0) until 7 (seven) days following that. All adverse events were collected during the period of Visit 1 (Day 0) to Visit 2 (between Day 21 and Day 28). Serum samples for immunogenicity assays were collected immediately before immunization on Visit 1 (Day 0) and on Visit 2 (between Day 21 and Day 28) in all subjects. Immunogenicity was evaluated by HI test.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
120
Single intramuscular injection with Fluval AB suspension for injection in both age groups
Family Doctor's Office
Budapest, Hungary
District Doctor's Office
Pilisvörösvár, Hungary
District Doctor's Office
Szentendre, Hungary
Change in Geometric Mean Titre Ratio, A/H1N1 Strain
Ratio of Day 0 and Day 21-28 antihaemagglutination inhibition titres Requirement (Age group 1): ≥ 2.5 Requirement (Age group 2): ≥ 2.0
Time frame: 21-28 days after vaccination
Change in Geometric Mean Titre Ratio, A/H3N2 Strain
Ratio of Day 0 and Day 21-28 antihaemagglutination inhibition titres Requirement (Age group 1): ≥ 2.5 Requirement (Age group 2): ≥ 2.0
Time frame: 21-28 days after vaccination
Change in Geometric Mean Titre Ratio, B Strain
Ratio of Day 0 and Day 21-28 antihaemagglutination inhibition titres Requirement (Age group 1): ≥ 2.5 Requirement (Age group 2): ≥ 2.0
Time frame: 21-28 days after vaccination
Seroconversion, A/H1N1 Strain
Percentage of subjects seroconverted or had a significant increase in titres Requirement (Age group 1): \> 40 % Requirement (Age group 2): \> 30 %
Time frame: 21-28 days after vaccination
Seroconversion, A/H3N2 Strain
Percentage of subjects seroconverted or had a significant increase in titres Requirement (Age group 1): \> 40 % Requirement (Age group 2): \> 30 %
Time frame: 21-28 days after vaccination
Seroconversion, B Strain
Percentage of subjects seroconverted or had a significant increase in titres Requirement (Age group 1): \> 40 % Requirement (Age group 2): \> 30 %
Time frame: 21-28 days after vaccination
Seroprotection, A/H1N1 Strain
Percentage of subjects seroprotected Requirement (Age group 1): \> 70 % Requirement (Age group 2): \> 60 %
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Time frame: 21-28 days after vaccination
Seroprotection, A/H3N2 Strain
Percentage of subjects seroprotected Requirement (Age group 1): \> 70 % Requirement (Age group 2): \> 60 %
Time frame: 21-28 days after vaccination
Seroprotection, B Strain
Percentage of subjects seroprotected Requirement (Age group 1): \> 70 % Requirement (Age group 2): \> 60 %
Time frame: 21-28 days after vaccination