Concomitant Administration of 13-valent Pneumococcal Conjugate Vaccine (13vPnC) With Influenza Vaccine in 23-valent Pneumococcal Polysaccharide (23vPS) Pre-vaccinated Adults.
Condition: PREVENTION OF INVASIVE PNEUMOCOCCAL DISEASE
MeSH terms: Pneumococcal Infections
Intervention: 13-valent pneumococcal conjugate vaccine; Seasonal Inactivated Influenza Vaccine; Placebo; Placebo; Seasonal Inactivated Influenza Vaccine; 13-valent pneumococcal conjugate vaccine
Intervention description: One (1) dose (0.5 mL) will be administered intramuscularly into the left deltoid either at Visit 1 or at Visit 2, depending on the randomization group assigned to the subject.; One (1) dose of SIIV will be administered intramuscularly into the right deltoid of all subjects at Visit 1.; One (1) dose (0.5 mL) will be administered intramuscularly into the left deltoid either at Visit 1 or at Visit 2, depending on the randomization group assigned to the subject.; One (1) dose (0.5 mL) will be administered intramuscularly into the left deltoid either at Visit 1 or at Visit 2, depending on the randomization group assigned to the subject.; One (1) dose of SIIV will be administered intramuscularly into the right deltoid of all subjects at Visit 1.; One (1) dose (0.5 mL) will be administered intramuscularly into the left deltoid either at Visit 1 or at Visit 2, depending on the randomization group assigned to the subject.
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 882.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pneumococcal polysaccharide vaccine; 13-valent pneumococcal conjugate vaccine; invasive pneumococcal disease; flu vaccine

Summary:

      The purpose of this study is to evaluate the immunogenicity and safety of 13-valent
      pneumococcal polysaccharide vaccine when given concomitantly with seasonal inactivated
      influenza vaccine to adults 50 years and older who have previously received 23-valent
      pneumococcal polysaccharide vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Evidence of a personally signed and dated informed consent document (ICD) indicating
             that the subject has been informed of all pertinent aspects of the study.

          2. Male or female adults 50 years of age or older.

          3. Documented vaccination with 1 or more prior doses of 23vPS, the last given at least 1
             year prior to study enrollment.

          4. Negative urine pregnancy test for all female subjects who are of child bearing
             potential.

        Exclusion Criteria:

          1. Previous vaccination with Prevnar®, Prevnar 13®, or any other investigational
             pneumococcal conjugate vaccine.

          2. History of severe adverse reactions associated with any vaccine or vaccine-related
             component.

          3. Allergic to egg proteins (egg or egg products) and chicken proteins.

          4. History of Guillain-Barré syndrome.

          5. Vaccination with any influenza vaccine within 6 months (182 days) before
             investigational product administration.

          6. Documented S pneumoniae infection within the past 5 years before investigational
             product administration.