Study Evaluating 13-valent Pneumococcal Conjugate Vaccine In Healthy Infants
Public ClinicalTrials.gov record NCT00444457. 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, Active-Controlled, Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of Three Lots of 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in the United States
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study will be to evaluate safety, tolerability and immunogenicity of three lots of 13-valent pneumococcal vaccine given to healthy infants. Lots will be studied for consistency of the immune response, as well as for non-inferiority and safety as compared to 7-valent Pneumococcal Conjugate Vaccine.
Study identification
- NCT ID
- NCT00444457
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,712 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 42 Days to 98 Days
- 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
- May 2007 (Type not available)
- Primary completion
- Jun 2009 (Actual)
- Completion
- Jun 2009 (Actual)
- Last update posted
- Oct 15, 2012
2007 – 2009
United States locations
- U.S. sites
- 78
- U.S. states
- 27
- U.S. cities
- 70
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Benton | Arkansas | 72019 | — |
| Not listed | Conway | Arkansas | 72033 | — |
| Not listed | Fayetteville | Arkansas | 72703 | — |
| Not listed | Jonesboro | Arkansas | 72401 | — |
| Not listed | Little Rock | Arkansas | 72205 | — |
| Not listed | North Little Rock | Arkansas | 72117 | — |
| Not listed | Downey | California | 90242 | — |
| Not listed | Fontana | California | 92335 | — |
| Not listed | Fountain Valley | California | 92708 | — |
| Not listed | Lakewood | California | 90805 | — |
| Not listed | Loma Linda | California | 92354 | — |
| Not listed | Moreno Valley | California | 92557 | — |
| Not listed | Paramount | California | 90723 | — |
| Not listed | Riverside | California | 92505 | — |
| Not listed | Rolling Hills Estates | California | 90274 | — |
| Not listed | Boulder | Colorado | 80303 | — |
| Not listed | Longmont | Colorado | 80501 | — |
| Not listed | Norwich | Connecticut | 06360 | — |
| Not listed | Palm Beach Gardens | Florida | 33410 | — |
| Not listed | Tampa | Florida | 33606 | — |
| Not listed | Atlanta | Georgia | 30322 | — |
| Not listed | Marietta | Georgia | 30062 | — |
| Not listed | Woodstock | Georgia | 30189 | — |
| Not listed | Nampa | Idaho | 83686 | — |
| Not listed | Chicago | Illinois | 60647 | — |
| Not listed | DeKalb | Illinois | 60115 | — |
| Not listed | Bardstown | Kentucky | 40004 | — |
| Not listed | Crestview Hills | Kentucky | 41017 | — |
| Not listed | Louisville | Kentucky | 40202 | — |
| Not listed | Louisville | Kentucky | 40207 | — |
| Not listed | Boston | Massachusetts | 02111 | — |
| Not listed | Boston | Massachusetts | 02116 | — |
| Not listed | Fall River | Massachusetts | 02124 | — |
| Not listed | Jamaica Plain | Massachusetts | 02130 | — |
| Not listed | Jackson | Mississippi | 39216 | — |
| Not listed | St Louis | Missouri | 63110 | — |
| Not listed | Omaha | Nebraska | 68127 | — |
| Not listed | Omaha | Nebraska | 68131 | — |
| Not listed | Lebanon | New Hampshire | 03756 | — |
| Not listed | Whitehouse Station | New Jersey | 08809 | — |
| Not listed | Fishkill | New York | 12524 | — |
| Not listed | Hopewell Jct | New York | 12533 | — |
| Not listed | Ithaca | New York | 14850 | — |
| Not listed | Syracuse | New York | 13202 | — |
| Not listed | The Bronx | New York | 10467 | — |
| Not listed | Cary | North Carolina | 27518 | — |
| Not listed | Durham | North Carolina | 27704 | — |
| Not listed | Durham | North Carolina | 27705 | — |
| Not listed | Sylva | North Carolina | 28779 | — |
| Not listed | Bismarck | North Dakota | 58501 | — |
| Not listed | Fargo | North Dakota | 58103 | — |
| Not listed | Cincinnati | Ohio | 45245 | — |
| Not listed | Cleveland | Ohio | 44121 | — |
| Not listed | Huber Heights | Ohio | 45424 | — |
| Not listed | Kettering | Ohio | 45429 | — |
| Not listed | Mason | Ohio | 45040 | — |
| Not listed | Tulsa | Oklahoma | 74127 | — |
| Not listed | Kittanning | Pennsylvania | 16201 | — |
| Not listed | Latrobe | Pennsylvania | 15650 | — |
| Not listed | Pittsburgh | Pennsylvania | 15227 | — |
| Not listed | Pittsburgh | Pennsylvania | 15236 | — |
| Not listed | Pittsburgh | Pennsylvania | 15241 | — |
| Not listed | Clarksville | Tennessee | 37043 | — |
| Not listed | Franklin | Tennessee | 37067 | — |
| Not listed | Jackson | Tennessee | 38305 | — |
| Not listed | Kingsport | Tennessee | 37660 | — |
| Not listed | Galveston | Texas | 77555 | — |
| Not listed | San Antonio | Texas | 78212 | — |
| Not listed | Layton | Utah | 84041 | — |
| Not listed | Murray | Utah | 84107 | — |
| Not listed | South Jordan | Utah | 84095 | — |
| Not listed | Vienna | Virginia | 22180 | — |
| Not listed | Vancouver | Washington | 98664 | — |
| Not listed | Vancouver | Washington | 98684 | — |
| Not listed | Vancouver | Washington | 98686 | — |
| Not listed | La Crosse | Wisconsin | 54601 | — |
| Not listed | Marshfield | Wisconsin | 54449 | — |
| Not listed | Monroe | Wisconsin | 53566 | — |
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 NCT00444457, 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 Oct 15, 2012 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00444457 live on ClinicalTrials.gov.