A Phase 3, Randomized, Active-Controlled, Modified Double-Blind Trial, Evaluating the Safety, Tolerability, and Immunogenicity of a 13-Valent Pneumococcal Conjugate Vaccine Compared With a 23-Valent Pneumococcal Polysaccharide Vaccine (23vPS) in Ambulatory Elderly Individuals Aged 70 Years and Older Who Received 1 Dose of 23vPS at Least 5 Years Before Study Enrollment

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 924

Inclusion Criteria

[1] Male or female adult 70 years of age or older at the time of enrollment.
[2] Documented vaccination with 1 dose of 23vPS at least 5 years before study enrollment.
[3] Determined by medical history, physical examination, and clinical judgment to be eligible for the study. Subjects with preexisting stable disease, defined as disease not requiring significant change in therapya or hospitalization for worsening disease 12 weeks before receipt of the test article, are eligible.
[4] Able to complete an electronic diary (e-diary) and follow study procedures in the opinion of the investigator.
[5] Expected to be available for the duration of the trial (approximately 18 months).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

[1] History of severe adverse reaction associated with a vaccine.
[2] Receipt of more than one 23vPS dose before study enrollment or any prior pneumococcal conjugate vaccine.
[3] Receipt of any vaccine within 30 days before test article administration, except influenza vaccine.
[4] Vaccination with a diphtheria-containing vaccine within 6 months before test article administration or anticipated receipt before study completion.
[5] Documented S pneumoniae infection within the past 5 years.
[6] Known or suspected immunodeficiency or receiving treatment with immunosuppressive therapy including cytotoxic agents or systemic corticosteroids, eg, for cancer, HIV or autoimmune disease. If systemic corticosteroids have been administered short term for treatment of an acute illness, subjects should be excluded from the study until corticosteroid therapy has been discontinued for at least 30 days.
[7] Serious chronic disorders including metastatic malignancy, severe chronic obstructive pulmonary disease (COPD) requiring supplemental oxygen, end stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that in the investigator’s opinion precludes the subject from participating in the study.
[8] Residence in a nursing home, long-term care facility, or other institution or requirement of semiskilled nursing care. An ambulatory subject, who is a resident of a retirement home or village, is eligible for the trial.
[9] Evidence of dementia or other severe cognitive impairment based on a Mini-Mental State Examination (MMSE) score of less than or equal to 21.
[10] Poor or missing eyesight, requiring third-party support to read.
[11] Receipt of any blood products, including immunoglobulin, within 6 months before test article administration or anticipated receipt before study completion.
[12] In the opinion of the investigator, unable to receive a vaccination in the deltoid muscle of either arm because of insufficient muscle mass or unable to grade limitation of arm movement that would interfere with the evaluation of the study objectives.
[13] Currently on anticoagulant therapy or a history of bleeding diathesis that would contraindicate intramuscular (IM) injection.
[14] Intent to receive any other investigational vaccine or agent from 1 month (30 days) before enrollment until the conclusion of the study.
[15] Any medical condition that would, in the opinion of the investigator, interfere with the evaluation of the study objectives.