Immunogenicity and Tolerability Study of Fluval AB Novo Suspension for Injection for Children and Adolescents

STUDY PERIOD: Length of enrollment: 2 weeks (estimated) Participation per subject: max. 1 month OBJECTIVES: Immunogenicity Objectives: To assess immunogenicity of a single intramuscular injection of Fluval AB Novo suspension for injection (trivalent, seasonal influenza vaccine, active ingredient content: 6 μg HA/0.5 ml of seasonal A/H1N1, A/H3N2 and B influenza antigens each), as measured by haemagglutination inhibition (HI) test. Safety and Tolerability Objectives: To evaluate safety and tolerability (incidence of adverse events) of a single intramuscular injection of Fluval AB Novo suspension for injection. CLINICAL PHASE: Phase III TYPE: Interventional, prevention DESIGN: Non-controlled, open, multi-centre METHODS: In this uncontrolled, open, multi-centre immunogenicity and tolerability study subjects were enrolled into two groups according to age: Age group 1: children (3-11 years): single intramuscular injection of Fluval AB Novo 0.25 ml suspension for injection; Age group 2: adolescents (12-18 years): single intramuscular injection of Fluval AB Novo 0.5 ml suspension for injection; Subjects were observed for 30 minutes after the injection for any immediate reactions. All adolescent subjects aged 12 to 18 years and the legitimate representatives of all volunteers were requested to complete a Diary Card (DC) to record local reactions (injection site pain, erythema, swelling, induration, numbness, sensitivity and haematoma) and systemic reactions (fever, shivering, headache, malaise, fatigue, sweating, nausea, myalgia, arthralgia, dizziness and urticaria) starting on the day of vaccination on Visit 1 (Day 0) until 7 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 were evaluated by HI test. INVESTIGATIONAL MEDICINAL PRODUCT: Fluval AB Novo suspension for injection (trivalent, seasonal influenza vaccine, active ingredient content: 6 μg HA/0.5 ml of seasonal A/H1N1, A/H3N2 and B influenza antigens each) with aluminium phosphate gel adjuvant. Lot No.: FL-N-05/13 CONCOMITANT VACCINES: No concomitant vaccination is permitted for the duration of the study except for post-exposure vaccination in a medical emergency (e.g. tetanus, rabies, hepatitis). STUDY POPULATION: Considering approximately 17% of drop-out (one participant out of six), in total 120 subjects (60 subjects in each age group) were enrolled in order to achieve at least 100 evaluable subjects (50 subjects in each age group).