Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Adults 60 Through 64 Years of Age
Status: | Active, not recruiting |
---|---|
Conditions: | Pneumonia, Infectious Disease |
Therapuetic Areas: | Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 60 - 64 |
Updated: | 8/5/2018 |
Start Date: | October 10, 2017 |
End Date: | December 10, 2018 |
A Phase 2, Randomized, Double-blind Trial To Evaluate The Safety And Immunogenicity Of A Multivalent Pneumococcal Conjugate Vaccine In Adults 60 Through 64 Years Of Age
This is a Phase 2, randomized, double-blinded study with a 2-arm parallel design. Healthy
adults aged 60 through 64 years of age with no history of pneumococcal vaccination will be
randomized equally to receive either a single intramuscular dose of multivalent pneumococcal
conjugate vaccine followed 1 month later with a dose of saline or Prevnar 13 followed 1 month
later with a dose of PPSV23 (control group).
adults aged 60 through 64 years of age with no history of pneumococcal vaccination will be
randomized equally to receive either a single intramuscular dose of multivalent pneumococcal
conjugate vaccine followed 1 month later with a dose of saline or Prevnar 13 followed 1 month
later with a dose of PPSV23 (control group).
Inclusion Criteria:
1. Male or female adults >/= 60 to =64 years of age (from the 60th birthday up to, but
not including, the 65th birthday) at enrollment.
2. Healthy adults, including adults with preexisting stable disease, defined as disease
not requiring significant change in therapy or requiring hospitalization within 3
months before receipt of investigational product, as determined by medical history,
physical examination, laboratory screening, and clinical judgment of the investigator.
3. Female subjects who are not of childbearing potential.
Exclusion Criteria:
1. Previous vaccination with any licensed or investigational pneumococcal vaccine, or
planned receipt through study participation.
2. History of microbiologically proven invasive disease caused by S pneumoniae.
3. Serious chronic disorder including metastatic malignancy, severe chronic obstructive
pulmonary disease (COPD) requiring supplemental oxygen, end-stage renal disease with
or without dialysis, clinically unstable cardiac disease, or any other disorder that,
in the investigator's opinion, excludes the subject from participating in the study.
We found this trial at
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