A Phase IIb, Open-Label, Dose Ranging Study of 13-Valent Pneumococcal Conjugate Vaccine in Adults 55 Through 74 Years of Age Previously Vaccinated With 23-Valent Pneumococcal Polysaccharide Vaccine
Condition: Pneumococcal Infection
MeSH terms: Pneumococcal Infections
Intervention: Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]
Intervention description: Prevnar 13 (PCV13) 13-valent pneumococcal conjugate vaccine. All doses given on Day 0. Group IA and IB (open-label): 0.5 mL intramuscular (IM) injection; Group IIA (open-label, randomized): 0.5 mL IM injection; Group IIB (open-label, randomized): 0.5 mL IM injection in the right arm and 0.5 mL IM in the left arm.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Enrollment: 884.0
Sex: All
Minimum age: 55 Years
Maximum age: 74 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: 13-valent; 23-valent; elderly; parent protocol; Pneumococcal infections; vaccine

Summary:

      The proposed phase IIb randomized, open label, dose ranging, safety and immunogenicity study
      will evaluate two different doses of 13-valent pneumococcal conjugate vaccine (PCV13) in two
      groups of participants (55 through 74 years of age). First group vaccine naïve participants
      will be open-label to receive a single injection of 0.5 mL PCV13. Second group of participant
      previously vaccinated with 23-valent pneumococcal polysaccharide vaccine (PPSV23) will be
      randomized 1:1 to receive two injections of 0.5 mL PCV13, one dose in each arm (Group IIA or
      Group IIB). Blood samples will be obtained at baseline, at one month and six months
      post-vaccination. The primary objectives are: to determine if two 0.5 mL doses of PCV13 are
      statistically significantly more immunogenic than a single 0.5 mL dose of PCV13 for at least
      some of the vaccine serotypes among participants 55 through 74 years of age previously
      vaccinated with PPSV23, as measured by serotype-specific OPA titers 28 days after study
    

Eligibility criteria:

        Inclusion Criteria:

        1. Male or female adults 55 through 74 years of age at the time of enrollment who are able
        to provide informed consent. 2. For the pneumococcal vaccine-naïve group (Group I), no
        pneumococcal vaccine received prior to enrollment, as documented by participant report and
        review of available vaccine records. For the previously vaccinated group (Group II),
        documented vaccination with exactly one dose of PPSV23 administered >/=3 and </=7 years
        prior to enrollment and no other lifetime doses of PPSV23. (History of receipt or
        non-receipt of a pneumococcal vaccine may be presumptively ascertained by participant
        report but must be confirmed by review of primary source information, including but not
        limited to medical records, primary care or other provider report, and health department
        records. Medical records should be reviewed and/or primary care or other providers queried
        to identify pneumococcal vaccinations administered for a period of not less than 10 years
        prior to enrollment.) 3. Determined by medical history, targeted physical examination (if
        indicated), and clinical judgment to be eligible for the study. Subjects with preexisting
        stable disease, defined as disease not requiring significant change in therapy (A change in
        dose or therapy within a category (e.g., change from one nonsteroidal anti-inflammatory
        drug to another) is allowed. A change to a new therapy category (e.g. surgery or addition
        of a new pharmacological class) is only allowed if it is not caused by worsening disease.)
        or hospitalization for worsening disease 12 weeks prior to enrollment, are eligible. 4.
        Agree not to receive a live virus vaccine (for example, zoster vaccine) before the Day 28
        (Visit 03) blood specimen collection and not to receive an inactivated vaccine (for
        example, inactivated influenza vaccine) within 14 days after enrollment. 5. The subject is
        able to understand and comply with the planned study procedures including being available
        for all study visits. 6. The subject has provided informed consent prior to any study
        procedures.

        Exclusion Criteria:

        1. Receipt of any PCV or investigational pneumococcal vaccine prior to enrollment. 2.
        Receipt of any inactivated vaccine within 14 days prior to enrollment or receipt of any
        live vaccine within 30 days prior to enrollment. 3. Receipt of an allergy desensitization
        injection within 14 days prior to enrollment or planned receipt of an allergy
        desensitization injection within 7 days following enrollment. 4. Receipt of a diphtheria
        toxoid containing vaccine (for example, tetanus and diphtheria toxoid [Td] or tetanus and
        diphtheria toxoid and acellular pertussis [TdaP] vaccine) within six months prior to
        enrollment. 5. Known or suspected immunodeficiency, receipt of cancer chemotherapy or
        radiation therapy within the preceding 36 months, or receiving treatment with
        immunosuppressive therapy, including systemic corticosteroids, e.g., for cancer, HIV or
        autoimmune disease. If any systemic (oral, parenteral) corticosteroids have been
        administered for treatment of acute illness within 30 days of vaccination, and any long
        term use (>2 weeks) in the 30 through 59 days before vaccination should be excluded.
        (Topical, intranasal, and inhaled corticosteroids are allowed.) 6. Serious chronic
        disorders including active or metastatic malignancy, hematologic malignancy, severe chronic
        obstructive pulmonary disease or clinically significant congestive heart failure,
        requirement for supplemental oxygen, end stage renal disease with or without dialysis,
        clinically unstable cardiac disease, or any other disorder that in the opinion of the
        investigator precludes the subject's participation. 7. Known HIV, hepatitis B or hepatitis
        C infection. 8. Residence in a nursing home or other skilled nursing facility or
        requirement for skilled nursing care. An ambulatory subject who does not require skilled
        nursing care and is a resident of a retirement home or community is eligible for the trial.
        9. Inability to provide informed consent or complete study activities, for example, due to
        dementia or other impairment. 10. Poor or missing eyesight, requiring third party support
        to read. 11. Receipt of any blood products, including immunoglobulin, within three months
        prior to enrollment. 12. Heart rate less than 40 bpm or greater than 120 bpm as measured at
        the enrollment visit and prior to vaccination. 13. Systolic blood pressure less than 90 mm
        Hg or greater than 170 mm Hg as measured at the enrollment visit and prior to vaccination.
        14. Diastolic blood pressure greater than 110 mm Hg as measured at the enrollment visit and
        prior to vaccination. 15. For Group I, unable to receive a vaccination in the deltoid
        muscle of the right arm and unable to receive a vaccination in the deltoid muscle of the
        left arm because of insufficient muscle mass, need to avoid injections due to prior lymph
        node dissection or radiation, or other factor. For Group II, unable to receive a
        vaccination in the deltoid muscle of one or both arms because of insufficient muscle mass,
        need to avoid injections due to prior lymph node dissection or radiation, or other factor.
        16. Currently on anticoagulant therapy (for example, warfarin, heparin [IV or SQ], or
        dabigatran) or a history of bleeding diathesis that would contraindicate intramuscular
        injection. (Aspirin, clopidogrel, dipyridamole, and nonsteroidal anti-inflammatory agents
        are allowed). 17. Known clinically significant allergic reaction to prior pneumococcal
        vaccination (for Group II participants) or to a component of PCV13 vaccine (PCV13 is latex
        free). 18. Current known abuse of alcohol or drug addiction that in the opinion of the
        Investigator may interfere with the subject's ability to comply with trial procedures. 19.
        Rec eipt of any other investigational vaccine or agent within one month before enrollment
        or intent to receive any other investigational vaccine or agent prior to the conclusion of
        the study. 20. Any medical condition that would, in the opinion of the investigator, place
        the participant at an unacceptable risk of an adverse event or interfere with the
        evaluation of the study objectives.