Phase 3
N=181
Comparing Two Pneumococcal Vaccines in Adults With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
Bottom Line
View on ClinicalTrials.gov: NCT00457977 ↗Enrolled (actual)
181
Serious AEs
32.6%
Results posted
May 2015
Primary outcome: Primary: Serotype Opsonization Titers — 10.85; 12.63; 132.51; 908.23 titers
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Pneumovax (PPSV23) (Biological); Prevnar (PCV7) (Biological)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serotype Opsonization Titers |
10.85; 12.63; 132.51; 908.23; 61.79; 268.52 | — |
| SECONDARY Serotype-specific Immunoglobulin G (IgG) Antibody Levels |
0.30; 0.28; 0.74; 1.95; 0.43; 0.70 | — |
Summary
Pneumococcal disease is a serious bacterial infection that can affect different parts of the body, including the lungs. People with chronic illnesses, such as chronic obstructive pulmonary disease (COPD), have a greater risk of developing pneumonia and meningitis as a result of pneumococcal disease. This study will compare the immune response to two types of pneumococcal vaccines in adults with COPD.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
- Post-bronchodilator forced expiratory volume at one second
/forced vital capacity (FEV1/FVC) level less than 70%
- Ten or more pack-years of smoking
- Willing to make return visits to the study clinic and accept telephone contact
- Last pneumococcal vaccination occured at least 5 years prior to study entry
Exclusion Criteria
- Asthma
- Sensitivity to pneumococcal vaccine
- Known bleeding disorder, or requires long-term anticoagulation therapy
- Presence of chronic disease that may impair pneumococcal vaccine response
- Acute illness requiring antibiotics in the month prior to study entry
- Medical condition that makes survival for 24 months following study entry unlikely
- Pregnant
Data sourced from ClinicalTrials.gov (NCT00457977). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.