Status:
COMPLETED
9-valent CRM 197 Pneumococcal
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Pneumococcal Infection
Eligibility:
All Genders
65+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety and immune response of a conjugated pneumococcal vaccine compared to a licensed 23-valent polysaccharide pneumococcal vaccine in elderly adults. Stu...
Detailed Description
Elderly individuals are at an increased risk for serious pneumococcal infection. The efficacy of the licensed pneumococcal vaccine is also lower in this at risk population. The precise immunologic rea...
Eligibility Criteria
Inclusion
- Persons age 65 years and older.
- Able to give informed consent. Informed consent will be assessed with a brief questionnaire.
- Subjects must be physically able to monitor and record side effects, including reading a digital thermometer and measuring erythema and induration, with assistance from others as needed.
- Subjects must be available for follow-up over the next 9 months
Exclusion
- Known previous receipt of licensed pneumococcal PS vaccination within the previous 5 years. Prior vaccination history will be obtained from current and previous health care providers, if available.
- Previous vaccination with any pneumococcal glycoconjugate vaccine.
- High risk medical condition for pneumococcus such as splenectomy, nephrotic syndrome, or lymphoma.
- Immunosuppressive diseases or immunosuppressive therapy. This includes doses of steroids greater than 10 mg daily (or its equivalent), cancer chemotherapy, or known HIV disease.
- History of idiopathic thrombocytopenic purpura.
- Acute respiratory illness or fever (temperature \>38 degrees C or 100.4 degrees F) within one week of vaccination. Subjects can be reconsidered for enrollment when they recover from their illness.
- History of allergy to any of the vaccine components or previous severe allergic reaction to any vaccination.
- Any medical condition that would in the opinion of the investigator, interfere with the evaluation of the study objectives.
- Documented S. pneumoniae infection in the past 5 years.
- Screening laboratory values outside the following limits: 1) hematocrit below 28%, 2) WBC \<3,000 or over 13,500 per ul, 3) platelets below 125,000 or above 500,000 per ul, 4) creatinine above 2.8 mg/dl or BUN above 75 mg/dl, and 5) AST/SGOT or ALT/SGPT over 110 U/L, Alkaline phosphatase over 200 IU/I or a bilirubin over 2.8 mg/dl.
Key Trial Info
Start Date :
November 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2002
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00133549
Start Date
November 1 2000
End Date
December 1 2002
Last Update
October 17 2014
Active Locations (2)
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1
University of Rochester
Rochester, New York, United States, 14642
2
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039