Immunogenicity and Tolerability Study of Fluval AB Novo Suspension for Injection for Children and Adolescents
Condition: Human Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      Immunogenicity and Tolerability Study of Fluval AB Novo Suspension for Injection (trivalent,
      seasonal influenza vaccine, active ingredient content: 6 μg HA/strain/0.5 ml) for Children
      and Adolescents.
    

Detailed description: 
      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).
    

Intervention name(s): Vaccination with Fluval AB Novo suspension for injection, half dose of a single intramuscular dose (0.25 ml); Vaccination with Fluval AB Novo suspension for injection, single intramuscular dose (0.5 ml)
Intervention type(s): Biological; Biological
Intervention description(s): vaccination; vaccination
Other intervention name(s): Fluval AB Novo suspension for injection
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: parallel-group study in two paediatric age groups
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: immunogenicity; reduced dose; Phase III; tolerability; safety