Status:
COMPLETED
Trial to Evaluate the Safety and Immunogenicity of 3 Lots of 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naïve Adults
Lead Sponsor:
Pfizer
Conditions:
Pneumococcal Disease
Eligibility:
All Genders
18-49 years
Phase:
PHASE3
Brief Summary
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 r...
Eligibility Criteria
Inclusion
- Male or female adults ≥18 and \<50 years of age.
- 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.
- 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
- Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
- 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.
- History of microbiologically proven invasive disease caused by S pneumoniae.
- Pregnant female subjects or breastfeeding female subjects (known or suspected).
Key Trial Info
Start Date :
February 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 9 2019
Estimated Enrollment :
1710 Patients enrolled
Trial Details
Trial ID
NCT03828617
Start Date
February 14 2019
End Date
October 9 2019
Last Update
November 23 2020
Active Locations (21)
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1
Anaheim Clinical Trials, LLC
Anaheim, California, United States, 92801
2
Kaiser Permanente Sacramento
Sacramento, California, United States, 95815
3
Kaiser Permanente South Sacramento
Sacramento, California, United States, 95823
4
Kaiser Permanente San Jose
San Jose, California, United States, 95119