9-valent CRM 197 Pneumococcal

Completed · Phase 2 · Has a placebo group

Conditions studied: Pneumococcal Infection

In brief

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. Study participants will include 180 adults, 65 years of age or greater. Participants will be randomly assigned to 1 of 3 possible groups. Subjects will maintain a study diary to record side effects and oral temperatures for 7 days following each vaccination. Blood samples will be collected before and 1 month following each dose of vaccine or placebo. Participants will be involved in study related procedures for up to 268 days.

Key facts

Study ID

NCT00133549

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

180

Starts

2000-11-01

Expected to finish

2002-12-01

Last updated by the study team

2014-10-17

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of Rochester — Rochester, New York, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.