Status:
COMPLETED
A Trial To Evaluate A Multivalent Pneumococcal Conjugate Vaccine In Healthy Adults 50-85 Years Of Age
Lead Sponsor:
Pfizer
Conditions:
Pneumococcal Infections
Eligibility:
All Genders
50-85 years
Phase:
PHASE2
Brief Summary
This is a 2-stage, phase 1/2, randomized, active-controlled, observer-blinded study with a 2-arm parallel design in each stage. In Stage 1 healthy adults 50 to 64 years of age with no history of pneu...
Eligibility Criteria
Inclusion
- Stage 1: Healthy male or female adults 50 to 64 years of age with no history of pneumococcal vaccination
- Stage 2: Healthy male or female adults 65 to 85 years of age previously vaccinated with Prevnar 13 \>= 2 months prior to investigational product administration
Exclusion
- Stage 1: Vaccination within 12 months before investigational product administration with diphtheria-, pertussis-, or tetanus-containing vaccine
- Stage 2: Previous vaccination with any pneumococcal vaccine other than a single prior dose of Prevnar 13
Key Trial Info
Start Date :
October 12 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 24 2019
Estimated Enrollment :
511 Patients enrolled
Trial Details
Trial ID
NCT03313050
Start Date
October 12 2017
End Date
May 24 2019
Last Update
June 4 2020
Active Locations (18)
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1
Achieve Clinical Research LLC
Birmingham, Alabama, United States, 35216
2
Core Healthcare Group
Cerritos, California, United States, 90703
3
Meridian Clinical Research, LLC
Savannah, Georgia, United States, 31406
4
Augusta Family Practice
Augusta, Kansas, United States, 67010