A Trial To Evaluate A Multivalent Pneumococcal Conjugate Vaccine In Healthy Adults 50-85 Years Of Age
Public ClinicalTrials.gov record NCT03313050. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A PHASE 1/2, RANDOMIZED, OBSERVER-BLINDED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY ADULTS 50 THROUGH 85 YEARS OF AGE
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 pneumococcal vaccination will be randomized equally to receive either a single intramuscular dose of multivalent pneumococcal conjugate vaccine or a licensed tetanus, diphtheria, acellular pertussis combination vaccine (Tdap) (control group). In Stage 2 healthy adults 65 to 85 years of age previously vaccinated with Prevnar 13 \>=2 months prior to investigational product administration will be randomized equally to receive either a single intramuscular dose of multivalent pneumococcal conjugate vaccine or the licensed 23-valent pneumococcal polysaccharide vaccine (control group).
Study identification
- NCT ID
- NCT03313050
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 511 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 50 Years to 85 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
- Oct 12, 2017 (Actual)
- Primary completion
- May 24, 2019 (Actual)
- Completion
- May 24, 2019 (Actual)
- Last update posted
- Jun 4, 2020
2017 – 2019
United States locations
- U.S. sites
- 18
- U.S. states
- 10
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Achieve Clinical Research LLC | Birmingham | Alabama | 35216 | — |
| Core Healthcare Group | Cerritos | California | 90703 | — |
| Meridian Clinical Research, LLC | Savannah | Georgia | 31406 | — |
| Augusta Family Practice | Augusta | Kansas | 67010 | — |
| Heartland Research Associates, LLC | Augusta | Kansas | 67010 | — |
| Axtell Clinic, P.A. | Newton | Kansas | 67114 | — |
| Heartland Research Associates, LLC | Newton | Kansas | 67114 | — |
| Heartland Research Associates, LLC | Wichita | Kansas | 67205 | — |
| Kentucky Pediatric/Adult Research | Bardstown | Kentucky | 40004 | — |
| Meridian Clinical Research, LLC | Norfolk | Nebraska | 68701 | — |
| Meridian Clinical Research LLC | Omaha | Nebraska | 68134 | — |
| PMG Research of Charlotte, LLC | Charlotte | North Carolina | 28209 | — |
| PMG Research of Wilmington, LLC | Wilmington | North Carolina | 28401 | — |
| Omega Medical Research | Warwick | Rhode Island | 02886 | — |
| Medical Research South, LLC | Goose Creek | South Carolina | 29445 | — |
| J. Lewis Research Incorporated, Foothill Family Clinic | Salt Lake City | Utah | 84109 | — |
| J. Lewis Research, Incorporated/Foothill Family Clinic South | Salt Lake City | Utah | 84121 | — |
| Advanced Clinical Research | West Jordan | Utah | 84088 | — |
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 NCT03313050, 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 Jun 4, 2020 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03313050 live on ClinicalTrials.gov.