Second Extension Study to Evaluate Safety and Tolerability of Influenza Vaccines in Adults and Elderly, and to Evaluate Immunogenicity and Concomitant Vaccination With Pneumococcal Vaccine in a Subgroup
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Cell culture derived seasonal trivalent influenza vaccine (cTIV); Influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a).; cTIV or eTIV_a; cTIV+PV OR eTIV_a+PV
Intervention description: cell cultured trivalent influenza vaccine (cTIV) vaccine administered as 0.5 mL single dose in the deltoid muscle, preferably of the non-dominant arm.; egg based trivalent influenza vaccine (eTIV_a) administered as 0.5 mL single dose in the deltoid muscle, preferably of the non-dominant arm.; 0.5 mL, Single dose of either cell cultured trivalent influenza vaccine (cTIV) or egg based trivalent influenza vaccine eTIV_a administered.; 0.5 mL, Single dose of either cell culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) administered concomitantly with 23-valent pneumococcal polysaccharide vaccine (PV).
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 1522.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The study primarily aims to evaluate immunogenicity and safety of influenza vaccines (cell
      culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine
      (egg-derived seasonal trivalent, thiomersal free; eTIV_a)) when administered alone and when
      administered concomitantly with pneumococcal polysaccharide vaccine (PV) in elderly subjects.
      The study also aimed to evaluate safety and immunogenicity (subset) of annual vaccination
      with either cTIV or eTIV_a in adults and elderly subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  participation in the V58P4 study

          -  mentally competent to understand the nature, the scope and the consequences of the
             study

          -  able and willing to give written informed consent prior to study entry

          -  available for all the visits scheduled in the study

        Exclusion Criteria:

          -  receipt of another investigational agent within 90 days prior to, or before completion
             of the safety follow-up period in another study, whichever is longer, prior to Visit 7
             and unwilling to refuse participation in another clinical study through the end of the
             present study

          -  history of any anaphylaxis, serious vaccine reactions, or allergy to any of the
             vaccine components

          -  any acute respiratory disease or infections requiring systemic antibiotic or antiviral
             therapy (chronic antibiotic therapy for urinary tract prophylaxis was acceptable) or
             experienced fever (i.e., axillary temperature ≥ 38°C) within the 5 days prior to Visit
             7

          -  pregnant/breast feeding women, or women of childbearing potential who refuse to use a
             reliable contraceptive method during the three weeks after vaccination