Study Evaluating 13 Valent Pneumococcal Conjugate Vaccine With Trivalent Inactivated Influenza Vaccine
Public ClinicalTrials.gov record NCT00521586. 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 3, Randomized, Double-blind Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A 13-valent Pneumococcal Conjugate Vaccine (13vpnc) When Administered Concomitantly With Trivalent Inactivated Influenza Vaccine In Healthy Adults 50-59 Years Of Age Who Are Naive To 23-valent Pneumococcal Polysaccharide Vaccine And To Evaluate The Immune Response Of A Second Dose Of 13vpnc Administered 5 Years After Initial 13vpnc Vaccination
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is to evaluate the safety, tolerability and immune response when 13-valent pneumococcal conjugate vaccine (13vPnC) and the trivalent inactivated flu vaccine (TIV) are given together to healthy adults aged 50-59 years who are naive to 23-valent pneumococcal polysaccharide vaccine (23vPS), or when the vaccines are given 1 month apart. It will also evaluate the immune response to 13vPnC once per year for 4 years and then to a second dose of 13vPnC given 5 years after the first dose.
Study identification
- NCT ID
- NCT00521586
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,116 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 50 Years to 59 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
- Sep 2007 (Type not available)
- Primary completion
- Dec 2013 (Actual)
- Completion
- Dec 2013 (Actual)
- Last update posted
- Apr 9, 2015
2007 – 2013
United States locations
- U.S. sites
- 41
- U.S. states
- 17
- U.S. cities
- 32
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinical Research Advantage, Inc. | Chandler | Arizona | 85224 | — |
| Peninsula Research Associates | Rolling Hills Estates | California | 90274 | — |
| Clinical Trials Center Pediatric Infectious Diseases and Clinical Trials | Aurora | Colorado | 80045-7144 | — |
| Tampa Bay Medical Research, Inc. | Clearwater | Florida | 33761 | — |
| A. G. A. Clinical Trials | Hialeah | Florida | 33012 | — |
| Advanced Clinical Research | Meridian | Idaho | 83642 | — |
| Accelovance | Peoria | Illinois | 61602 | — |
| Suite 100 | Riverdale | Maryland | 20737 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Radiant Research, Inc | St Louis | Missouri | 63141 | — |
| Big Sky Clinical Research | Butte | Montana | 59701 | — |
| FFM Clinical Research | Camillus | New York | 13031 | — |
| Rochester Clinical Research | Rochester | New York | 14609 | — |
| University of Rochester Medical Center | Rochester | New York | 14642 | — |
| PMG Research of Raleigh, LLC | Cary | North Carolina | 27518 | — |
| Hickory Family Practice Associates | Hickory | North Carolina | 28601 | — |
| PMG Research of Hickory, LLC | Hickory | North Carolina | 28601 | — |
| Unifour Medical Research Associates, LLC | Hickory | North Carolina | 28601 | — |
| Unifour Medical Research Associates | Hickory | North Carolina | 28601 | — |
| Fairbrook Medical Clinic | Hickory | North Carolina | 28602 | — |
| PMG Research of Hickory, LLC | Hickory | North Carolina | 28602 | — |
| Unifour Medical Research Associates, LLC | Hickory | North Carolina | 28602 | — |
| PMG Research of Raleigh, LLC | Raleigh | North Carolina | 27609 | — |
| PMG Research of Salisbury | Salisbury | North Carolina | 28144 | — |
| PMG Research of Winston-Salem | Winston-Salem | North Carolina | 27103 | — |
| Cincinnati Children's Hospital Medical Center Gamble Program for Clinical Studies | Cincinnati | Ohio | 45206 | — |
| Rapid Medical Research, Inc. | Cleveland | Ohio | 44122 | — |
| Prestige Clinical Research | Franklin | Ohio | 45005 | — |
| Preferred Primary Care Physicians, Inc | Carnegie | Pennsylvania | 15106 | — |
| Family Healthcare Partners | Grove City | Pennsylvania | 16127 | — |
| Family Practice Medical Associates South, Jefferson Office | Jefferson Hills | Pennsylvania | 15025 | — |
| Kid's Plus Pediatrics | Pittsburgh | Pennsylvania | 15217 | — |
| Primary Physicians Research Inc. | Pittsburgh | Pennsylvania | 15241 | — |
| Family Practice Medical Associates South | Upper Saint Clair | Pennsylvania | 15241 | — |
| The Washington Hospital Family Medicine | Washington | Pennsylvania | 15301 | — |
| Internal Medicine & Pediatric Associates of Bristol, PC | Bristol | Tennessee | 37620 | — |
| PMG Research of Bristol, LLC | Bristol | Tennessee | 37620 | — |
| Volunteer Research Group | Knoxville | Tennessee | 37920 | — |
| Clark D. McKeever, M.D. Research for Health | Houston | Texas | 77055-6040 | — |
| Diagnostics Research Group | San Antonio | Texas | 78229 | — |
| 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 NCT00521586, 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 Apr 9, 2015 · Synced Nov 3, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00521586 live on ClinicalTrials.gov.