Pneumococcal Adult-dose Ranging Immunization Study

NCT00169234 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2017-10-13

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00169234 on ClinicalTrials.gov