Study Evaluating 13 Valent Pneumococcal Conjugate Vaccine With Trivalent Inactivated Influenza Vaccine

• Biological: 13 valent pneumococcal conjugate vaccine
  
  TIV +13vPnC at dose 1 placebo at dose 2, one month after dose 1 13vPnC at year 5
  Other Name: 0.5 mL dose of TIV and 13vPnC at dose 1, 0.5 mL dose of of placebo at dose 2, and 0.5ml dose of 13vPnC at year 5 will be administered into left deltoid muscle
• Biological: 13 valent pneumococcal conjugate vaccine
  
  TIV + placebo at dose 1 13vPnC at dose 2, one month after dose 1 and 13vPnC at year 5
  Other Name: 0.5 mL dose of TIV and of placebo at dose 1 and 0.5 mL dose of 13vPnC at dose 2 and year 5 will be administered into left deltoid muscle

• 1
  
  arm 1 = TIV +13vPnC at visit 1, placebo at visit 2 then 13vPnC at year 5
  Intervention: Biological: 13 valent pneumococcal conjugate vaccine
• 2
  
  arm 2 = TIV + placebo at visit 1, then 13vPnC at visit 2 and at year 5
  Intervention: Biological: 13 valent pneumococcal conjugate vaccine

• Frenck RW Jr, Fiquet A, Gurtman A, van Cleeff M, Davis M, Rubino J, Smith W, Sundaraiyer V, Sidhu M, Emini EA, Gruber WC, Scott DA, Schmoele-Thoma B; B1851020 Study Group. Immunogenicity and safety of a second administration of 13-valent pneumococcal conjugate vaccine 5 years after initial vaccination in adults 50 years and older. Vaccine. 2016 Jun 24;34(30):3454-62. doi: 10.1016/j.vaccine.2016.04.093. Epub 2016 May 5.
• Frenck RW Jr, Gurtman A, Rubino J, Smith W, van Cleeff M, Jayawardene D, Giardina PC, Emini EA, Gruber WC, Scott DA, Schmöle-Thoma B. Randomized, controlled trial of a 13-valent pneumococcal conjugate vaccine administered concomitantly with an influenza vaccine in healthy adults. Clin Vaccine Immunol. 2012 Aug;19(8):1296-303. doi: 10.1128/CVI.00176-12. Epub 2012 Jun 27.

Inclusion Criteria:

• Male or female aged 50 to 59 years
• Determined by medical history, physical examination and clinical judgement to be eligible for the study
• Able to complete electronic diary
• Available for the 5 year 9 month duration of the study

Exclusion Criteria:

• Previous vaccination with any licensed or experimental pneumococcal vaccine
• Allergic to egg proteins and chicken proteins
• History of Guillian-Barre syndrome
• Vaccination with TIV within 6 months before study start
• Vaccination with diphtheria-containing vaccine within 6 months of study start
• Serious chronic disorders including immunodeficiency or metastatic malignancy
• Known or suspected hypersensitivity to any vaccine or vaccine component