Trial to Evaluate the Safety and Immunogenicity of 3 Lots of 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naïve Adults
Status: | Recruiting |
---|---|
Conditions: | Infectious Disease |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - 49 |
Updated: | 3/28/2019 |
Start Date: | February 14, 2019 |
End Date: | December 16, 2019 |
Contact: | Pfizer CT.gov Call Center |
Email: | ClinicalTrials.gov_Inquiries@pfizer.com |
Phone: | 1-800-718-1021 |
A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF 3 LOTS OF 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN PNEUMOCOCCAL VACCINE-NAÏVE ADULTS 18 THROUGH 49 YEARS OF AGE
This is a Phase 3, randomized, double-blind study with a 4-arm parallel design. Adults 18
through 49 years of age with no history of pneumococcal vaccination will be randomized in a
2:2:2:1 ratio to receive a single dose of: 20vPnC Lot 1; 20vPnC Lot 2; 20vPnC Lot 3; or
13vPnC.
through 49 years of age with no history of pneumococcal vaccination will be randomized in a
2:2:2:1 ratio to receive a single dose of: 20vPnC Lot 1; 20vPnC Lot 2; 20vPnC Lot 3; or
13vPnC.
Inclusion Criteria:
1. Male or female adults ≥18 and <50 years of age.
2. Adults determined by clinical assessment, including medical history and clinical
judgment, to be eligible for the study, including adults with preexisting stable
disease, defined as disease not requiring significant change in therapy in the
previous 6 weeks or hospitalization for worsening disease within 12 weeks before
receipt of investigational product.
3. Female subject of childbearing potential or male subject who is able to father
children, and willing to use a highly effective method of contraception as outlined in
this protocol for at least 28 days after the dose of investigational product; or
female subject not of childbearing potential or male subject not able to father
children.
Exclusion Criteria:
1. Previous vaccination with any licensed or investigational pneumococcal vaccine, or
planned receipt through study participation.
2. 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.
3. History of microbiologically proven invasive disease caused by S pneumoniae.
4. Pregnant female subjects or breastfeeding female subjects (known or suspected).
We found this trial at
20
sites
Kaiser Permanente - Sacramento At the Kaiser Permanente South Sacramento Medical Center, you and your...
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Anaheim Clinical Trials, LLC Anaheim Clinical Trials (ACT) is a research center of excellence for...
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PMG Research of Wilmington PMG Research of Wilmington has two offices situated in a 1...
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