Pneumococcal infection MedDRA version: 9.1 Level: LLT Classification code 10061353 Term: Pneumococcal infection
Conditions
Sponsors
Wyeth Research Division of Wyeth Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] Male or female adult 65 years of age or older at time of enrollment. [2] 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 therapy or hospitalization for worsening disease 12 weeks before receipt of the test article, are eligible. [3] Able to complete an electronic diary (e-diary) and follow study procedures in the opinion of the investigator. [4] Expected to be available for the duration of the trial (approximately 2 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
Exclusion criteria: [1] Previous vaccination with any licensed or experimental pneumococcal vaccine. [2] History of severe adverse reaction associated with a vaccine. [3] Allergic to egg proteins (eggs or egg products) and chicken proteins. [4] History of Guillain-Barre syndrome. [5] Vaccination with TIV within 6 months before test article administration. [6] Vaccination with a diphtheria-containing vaccine within 6 months before test article administration or anticipated receipt before study completion. [7] Documented S pneumoniae infection within the past 5 years. [8] Residence in a nursing home, long-term care facility, or other institution or requirement of semi-skilled 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 or equal to 21. [10] Immunocompromised person who has known or suspected immunodeficiency or who receives 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. [11] Serious chronic disorder including metastatic malignancy, severe chronic obstructive pulmonary disease 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. [12] Poor or missing eyesight, requiring third-party support to read. [13] Receipt of any blood products, including immunoglobulin, within 6 months before test article administration or anticipated receipt before study completion. [14] In the opinion of the investigator, unable to receive a vaccination in the deltoid muscle of either arm due to insufficient muscle mass or unable to grade limitation of arm movement that would interfere with the evaluation of the study objectives. [15] Currently on anticoagulant therapy or have a history of bleeding diathesis that would contraindicate intramuscular (IM) injection. [16] Intent to receive any other investigational vaccine or agent from 1 month (30 days) before study enrollment until the conclusion of the study. [17] Any medical condition that would, in the opinion of the investigator, interfere with the evaluation of the study objectives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: [1] To demonstrate that the immune responses induced by TIV when administered concomitantly with 13vPnC are noninferior to the immune responses induced by TIV alone [2] To demonstrate that the immune responses to the 13vPnC serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) induced by 13vPnC when administered concomitantly with TIV are noninferior to the immune responses induced by 13vPnC administered 1 month after TIV [3] To evaluate the acceptability of the safety profile of 13vPnC+TIV given concomitantly and 13vPnC given alone;Secondary Objective: ;Primary end point(s): The primary immunological comparisons are the immune responses in subjects receiving 13vPnC and TIV concomitantly relative to the immune responses in subjects receiving either TIV alone or 13vPnC alone (1 month after initial vaccination with TIV). The primary endpoints for TIV comparisons are the proportion of subjects who achieve at least a 4-fold increase in the titer (ie, seroconvert) for each influenza virus subtype from visit 1 to 1 month after TIV vaccination. The primary endpoints for the pneumococcal comparisons are the serotype-specific pneumococcal IgG concentrations measured 1 month after 13vPnC vaccinate | — |
Countries
Belgium, Germany, Hungary, Netherlands
Outcome results
None listed