Study to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine Given With Prevnar 13 in Healthy Infants
Public ClinicalTrials.gov record NCT03550313. 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 2, RANDOMIZED, OPEN-LABEL TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE GIVEN WITH, OR SEPARATELY FROM, 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase 2, randomized, active-controlled, open-label study with a 3-arm parallel design. Healthy 2-month old infants (42 to 98 days of age) with no history of pneumococcal vaccination will be randomized in a 1:1:1 ratio to receive a 4-dose series of: multivalent pneumococcal conjugate vaccine coadministered with Prevnar 13 (Group 1); multivalent pneumococcal conjugate vaccine given 1 month after Prevnar 13 (Group 2); or Prevnar 13 with a single dose of multivalent pneumococcal conjugate vaccine (Group 3).
Study identification
- NCT ID
- NCT03550313
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 565 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
- Jun 1, 2018 (Actual)
- Primary completion
- Nov 5, 2020 (Actual)
- Completion
- Nov 5, 2020 (Actual)
- Last update posted
- Nov 30, 2021
2018 – 2020
United States locations
- U.S. sites
- 48
- U.S. states
- 22
- U.S. cities
- 37
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mobile Pediatric Clinic | Mobile | Alabama | 36607 | — |
| Harrisburg Family Medical Center | Harrisburg | Arkansas | 72432 | — |
| Emmaus Research Center, Inc. | Anaheim | California | 92804 | — |
| Hoag Memorial Hospital Presbyterian | Huntington Beach | California | 92648 | — |
| Madera Family Medical Group | Madera | California | 93637 | — |
| Orange County Research Institute | Ontario | California | 91762 | — |
| Center for Clinical Trials, LLC | Paramount | California | 90723 | — |
| Center for Clinical Trials | Paramount | California | 90723 | — |
| Gentle Medicine Associates | Boynton Beach | Florida | 33435 | — |
| Avail Clinical Research, LLC | DeLand | Florida | 32720 | — |
| Next Phase Research Alliance | Homestead | Florida | 33030 | — |
| Acevedo Clinical Research Associates | Miami | Florida | 33142 | — |
| Bio-Medical Research, LLC | Miami | Florida | 33184 | — |
| Crystal Biomedical Research, LLC | Miami Lakes | Florida | 33014 | — |
| IACT Health | Columbus | Georgia | 31903 | — |
| Advocate Children's Hospital | Park Ridge | Illinois | 60068 | — |
| MOC Research | Mishawaka | Indiana | 46544 | — |
| Michael W. Simon, MD, PSC | Lexington | Kentucky | 40517 | — |
| All Children Pediatrics | Louisville | Kentucky | 40243 | — |
| Meridian Clinical Research, LLC | Baton Rouge | Louisiana | 70806 | — |
| MedPharmics, LLC | Metairie | Louisiana | 70006 | — |
| LSUHSC-Shreveport | Shreveport | Louisiana | 71103 | — |
| Ochsner-LSU Health Shreveport | Shreveport | Louisiana | 71103 | — |
| Floating Hospital for Children at Tufts Medical Center | Boston | Massachusetts | 02111 | — |
| Pediatric Phlebotomy | Boston | Massachusetts | 02111 | — |
| Tufts Medical Center IDS - Pharmacy | Boston | Massachusetts | 02111 | — |
| Children's Mercy Clinics on Broadway | Kansas City | Missouri | 64111 | — |
| Children's Physicians Embassy Park | Omaha | Nebraska | 68114 | — |
| Children's Physicians Spring Valley | Omaha | Nebraska | 68117 | — |
| Creighton University Clinical Research Office | Omaha | Nebraska | 68131 | — |
| Child Health care Associates | East Syracuse | New York | 13057 | — |
| Blue Ridge Pediatric and Adolescent Medicine, Inc | Boone | North Carolina | 28607 | — |
| Sugarcamp Family Research | Dayton | Ohio | 45409 | — |
| Allegheny Health and Wellness Pavilion | Erie | Pennsylvania | 16506 | — |
| Coastal Pediatric Research | Charleston | South Carolina | 29414 | — |
| Parkside Pediatrics | Greenville | South Carolina | 29607 | — |
| Sanford Children's Specialty Clinic | Sioux Falls | South Dakota | 57105 | — |
| Sanford Research | Sioux Falls | South Dakota | 57105 | — |
| Sanford 69th & Louise Family Medicine | Sioux Falls | South Dakota | 57108 | — |
| Holston Medical Group | Kingsport | Tennessee | 37660 | — |
| Ventavia Research Group | Houston | Texas | 77008 | — |
| Mercury Clinical Research | Houston | Texas | 77054 | — |
| Pediatric Associates | Houston | Texas | 77087 | — |
| Ventavia Research Group | Keller | Texas | 76248 | — |
| Tekton Research, Inc. | San Antonio | Texas | 78240 | — |
| Ventavia Research Group, LLC | Spring | Texas | 77389 | — |
| Dixie Pediatrics | St. George | Utah | 84790 | — |
| Marshall Health | Huntington | West Virginia | 25701 | — |
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 NCT03550313, 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 30, 2021 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03550313 live on ClinicalTrials.gov.