Trial to Evaluate the Safety and Immunogenicity of 3 Lots of 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naïve Adults
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Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03828617
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,710 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 49 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 14, 2019 (Actual)
- Primary completion
- Oct 9, 2019 (Actual)
- Completion
- Oct 9, 2019 (Actual)
- Last update posted
- Nov 23, 2020
2019
United States locations
- U.S. sites
- 21
- U.S. states
- 13
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Anaheim Clinical Trials, LLC | Anaheim | California | 92801 | — |
| Kaiser Permanente Sacramento | Sacramento | California | 95815 | — |
| Kaiser Permanente South Sacramento | Sacramento | California | 95823 | — |
| Kaiser Permanente San Jose | San Jose | California | 95119 | — |
| Kaiser Permanente Santa Clara | Santa Clara | California | 95051 | — |
| Accel Research Sites - Clinical Research Unit | DeLand | Florida | 32720 | — |
| Research Centers of America, LLC | Hollywood | Florida | 33024 | — |
| Clinical Research Atlanta | Stockbridge | Georgia | 30281 | — |
| East West Medical Research Institute | Honolulu | Hawaii | 96814 | — |
| Heartland Research Associates, LLC | Wichita | Kansas | 67207 | — |
| Kentucky Pediatric/Adult Research | Bardstown | Kentucky | 40004 | — |
| Meridian Clinical Research, LLC | Norfolk | Nebraska | 68701 | — |
| Meridian Clinical Research, LLC | Omaha | Nebraska | 68134 | — |
| Rochester Clinical Research, Inc. | Rochester | New York | 14609 | — |
| M3 Wake Research, Inc. | Raleigh | North Carolina | 27612 | — |
| PMG Research of Wilmington, LLC | Wilmington | North Carolina | 28401 | — |
| Omega Medical Research | Warwick | Rhode Island | 02886 | — |
| Meridian Clinical Research, LLC | Dakota Dunes | South Dakota | 57049 | — |
| Benchmark Research | Austin | Texas | 78705 | — |
| J. Lewis Research, Inc. /Foothill Family Clinic | Salt Lake City | Utah | 84109 | — |
| J. Lewis Research, Inc. /Foothill Family Clinic South | Salt Lake City | Utah | 84121 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03828617, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 23, 2020 · Synced Nov 11, 2026
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