Pneumococcal Adult-dose Ranging Immunization Study
NCT00169234 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 220
Last updated 2017-10-13
Summary
The purpose of this study is to give seniors different doses of a new pneumococcal vaccine called PCV7 to evaluate the safety of the vaccine and compare the immune response to find out which amount gives the best immune response. The PCV7 vaccine is currently licensed by the FDA for use in infants and toddlers only.
Conditions
Interventions
- BIOLOGICAL
-
PCV7, Prevnar®
Randomized to receive 0.1mL, 0.5mL, 1.0mL or 2.0mL at the enrollment visit, followed by 0.1mL PPV23 12 months later.
- BIOLOGICAL
-
Pneumovax 23
Randomized to receive 0.5mL at the enrollment visit, followed by 0.1mL PPV23 12 months later.
Sponsors & Collaborators
-
Centers for Disease Control and Prevention
collaborator FED -
Kaiser Permanente
lead OTHER
Principal Investigators
-
Lisa A Jackson, MD, MPH · Kaiser Permanente
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- SINGLE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 70 Years
- Max Age
- 79 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-05-31
- Primary Completion
- 2005-02-28
- Completion
- 2005-02-28
Countries
- United States
Study Locations
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