Trial to Evaluate the Safety and Immunogenicity of 3 Lots of 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naïve Adults
NCT03828617 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1710
Last updated 2020-11-23
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 receive a single dose of: 20vPnC Lot 1; 20vPnC Lot 2; 20vPnC Lot 3; or 13vPnC.
Conditions
- Pneumococcal Disease
Interventions
- BIOLOGICAL
-
20vPnC
20vPnC
- BIOLOGICAL
-
20vPnC
20vPnC
- BIOLOGICAL
-
20vPnC
20vPnC
- BIOLOGICAL
-
13vPnC
Pneumococcal conjugate vaccine
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Pfizer CT.gov Call Center · Pfizer
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 49 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-02-14
- Primary Completion
- 2019-10-09
- Completion
- 2019-10-09
- FDA Drug
- Yes
Countries
- United States
Study Locations
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