ClinicalTrials.gov record
A Clinical Trial to Study the Safety, Tolerance and Immunogenic Response to MCV4, Tdap and Bivalent rLP2086 Vaccine When Given at the Same Time to Children Between the Ages of 10 Through 12 Years of Age
ClinicalTrials.gov ID: NCT01461980
Public ClinicalTrials.gov record NCT01461980. 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, Active-controlled, Observer-blinded Trial, To Assess The Safety, Tolerability, And Immunogenicity Of Mcv4, Tdap Vaccine And Bivalent Rlp2086 Vaccine When Administered Concomitantly In Healthy Subjects Aged > = 10 To <13 Years
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a clinical study to assess the safety, tolerance and immunogenic response to MCV4(quadrivalent meningococcal polysaccharide conjugate, meningococcal serogroups A,C,Y, and W135), Tdap (diphtheria, tetanus, and acellular pertussis), and bivalent rLP2086 vaccine. Healthy male and female subjects, between the ages of 10 to 12 years old, will be randomized into 1 of 3 groups. The subjects, investigators, site staff and sponsor will be blinded to all injections given throughout the study. An unblinded administrator will be responsible to administer the vaccinations to all subjects and will be unblinded to the subject randomization in order to determine which subjects were in randomized to group 3 so they may receive their catch-up vaccinations of MCV4 and Tdap. A final telephone contact will be conducted with all subjects 6-months post their last vaccination to obtain safety information.
Study identification
- NCT ID
- NCT01461980
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 2,648 participants
Conditions and interventions
Conditions
Interventions
- rLP2086 + MCV4 + Tdap Biological
- MCV4 + Tdap + saline Biological
- rLP2086 + saline Biological
Biological
Eligibility (public fields only)
- Age range
- 10 Years to 12 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 28, 2011 (Actual)
- Primary completion
- May 8, 2014 (Actual)
- Completion
- May 8, 2014 (Actual)
- Last update posted
- Dec 20, 2018
2011 – 2014
United States locations
- U.S. sites
- 117
- U.S. states
- 31
- U.S. cities
- 76
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Radiant Research, Inc. | Birmingham | Alabama | 35209 | — |
| Costal Clinical Research, Inc. | Daphne | Alabama | 36526 | — |
| Clinical Research Advantage Inc/ East Valley Family Physicians, PLC | Chandler | Arizona | 85224 | — |
| Radiant Research, Inc. | Chandler | Arizona | 85224 | — |
| Clinical Research Advantage, Inc./Mesa Family Medical Center, PC | Mesa | Arizona | 85203 | — |
| Clinical Research Advantage, Inc./Desert | Mesa | Arizona | 85213 | — |
| Radiant Research, Inc. | Tucson | Arizona | 85710 | — |
| Radiant Research, Inc. | Tucson | Arizona | 85712 | — |
| The Children's Clinic of Jonesboro, PA | Jonesboro | Arkansas | 72401 | — |
| Arkansas Pediatric Clinic | Little Rock | Arkansas | 72205 | — |
| Kaiser Permanente Fresno | Fresno | California | 93726 | — |
| Kaiser Permanente Hayward | Hayward | California | 94545 | — |
| Pediatric Care Medical Group | Huntington Beach | California | 92647 | — |
| Loma Linda University | Loma Linda | California | 92350 | — |
| Loma Linda University Health Care Pediatric Clinic | Loma Linda | California | 92354 | — |
| Loma Linda University Medical Center | Loma Linda | California | 92354 | — |
| Loma Linda University Health Care - Moreno Valley Pediatrics | Moreno Valley | California | 92557 | — |
| Bayview Research Group, LLC | Paramount | California | 90723 | — |
| Center for Clinical Trials, LLC | Paramount | California | 90723 | — |
| Kaiser Permanente Sacramento | Sacramento | California | 95815 | — |
| California Research Foundation | San Diego | California | 92103 | — |
| Bayview Research Group, LLC | Valley Village | California | 91607 | — |
| Lynn Institute of the Rockies | Colorado Springs | Colorado | 80907 | — |
| Colorado Springs Family Practice | Colorado Springs | Colorado | 80909 | — |
| Radiant Research, Inc. | Denver | Colorado | 80239 | — |
| Norwich Pediatric Group, P.C. | Norwich | Connecticut | 06360 | — |
| University of South Florida | Tampa | Florida | 33606 | — |
| Emory University School of Medicine Department of Pediatrics | Atlanta | Georgia | 30322 | — |
| Emory University School of Medicine | Atlanta | Georgia | 30322 | — |
| Radiant Research, Inc | Atlanta | Georgia | 30342 | — |
| North Georgia Clinical Research Center dba Whites Pediatrics | Dalton | Georgia | 30721 | — |
| Pediatrics and Adolescent Medicine, PA | Marietta | Georgia | 30062 | — |
| Pediatrics and Adolescent Medicine | Woodstock | Georgia | 30189 | — |
| Advanced Clinical Research | Meridian | Idaho | 83642 | — |
| Northern Illinois Research Associates | DeKalb | Illinois | 60115 | — |
| Clinical Research Advantage, Inc./ Ridge Family Practice, PC | Council Bluffs | Iowa | 51503 | — |
| Heartland Research Associates, LLC | Augusta | Kansas | 67010 | — |
| Heartland Research Associates, LLC | Wichita | Kansas | 67207 | — |
| Via Christi Clinic, P.A. | Wichita | Kansas | 67208 | — |
| Kentucky Pediatric/Adult Research | Bardstown | Kentucky | 40004 | — |
| University of Louisville Pediatrics: Children and Youth Project | Louisville | Kentucky | 40202 | — |
| Brownsboro Park Pediatrics | Louisville | Kentucky | 40207 | — |
| Bluegrass Clinical Research, Inc. | Louisville | Kentucky | 40291 | — |
| Southwestern Medical Clinic Lakeland Healthcare Affiliate | Stevensville | Michigan | 49127 | — |
| Allina Health Bandana Square Clinic | Saint Paul | Minnesota | 55108 | — |
| Aspen Medical Group/ Odyssey Research | Saint Paul | Minnesota | 55108 | — |
| Aspen Medical Group | Saint Paul | Minnesota | 55108 | — |
| The Center for Pharmaceutical Research, PC | Kansas City | Missouri | 64114 | — |
| Saint Louis University | St Louis | Missouri | 63104 | — |
| Mercy Health Research | St Louis | Missouri | 63141 | — |
| Radiant Research, Inc. | St Louis | Missouri | 63141 | — |
| Sundance Clinical Research, LLC | St Louis | Missouri | 63141 | — |
| Clinical Research Advantage, Inc. / Prairie Fields Family Medicine, PC | Fremont | Nebraska | 68025 | — |
| Midwest Children's Health Research Institute | Lincoln | Nebraska | 68504 | — |
| Quality Clinical Research, Inc. | Omaha | Nebraska | 68114 | — |
| Creighton Pediatric Infectious Diseases Creighton University Medical Center | Omaha | Nebraska | 68131 | — |
| Clinical Research Center of Nevada | Henderson | Nevada | 89014 | — |
| Clinical Research Center of Nevada | Las Vegas | Nevada | 89105 | — |
| Child Health Care Associates | East Syracuse | New York | 13057 | — |
| Duke University Medical Center - Duke Health Center | Durham | North Carolina | 27704 | — |
| Durham Pediatrics | Durham | North Carolina | 27704 | — |
| Duke Health Center | Durham | North Carolina | 27705 | — |
| PMG Research of Raleigh, LLC - | Raleigh | North Carolina | 27609 | — |
| PMG Research of Raleigh, LLC | Raleigh | North Carolina | 27609 | — |
| PMG Research of Raleigh, LLC | Raleigh | North Carolina | 27612 | — |
| Innovis Health | Fargo | North Dakota | 58103 | — |
| Odyssey Research | Fargo | North Dakota | 58104 | — |
| Radiant Research, Inc | Akron | Ohio | 44311 | — |
| Cincinnati Center for Clinical Research, Satellite Site - Clinic | Cincinnati | Ohio | 45206 | — |
| Cincinnati Childrens Hospital Medical Center Gamble Program for Clinical Studies | Cincinnati | Ohio | 45229-3039 | — |
| Dr. Shelly David Senders, MD Inc. dba Senders Pediatrics | Cleveland | Ohio | 44121 | — |
| Senders Pediatrics | Cleveland | Ohio | 44121 | — |
| Rapid Medical Research, Inc. | Cleveland | Ohio | 44122 | — |
| Radiant Research | Columbus | Ohio | 43212 | — |
| Ohio Pediatric Research Association | Dayton | Ohio | 45414 | — |
| Ohio Pediatrics, Inc. | Dayton | Ohio | 45414 | — |
| Ohio Pediatrics, Inc. | Huber Heights | Ohio | 45424 | — |
| Ohio Pediatric Research | Kettering | Ohio | 45420 | — |
| Christopher Brad Redden, ARNP Healthcare One Urgent Care and Family Practice | El Reno | Oklahoma | 73036 | — |
| Lynn Institute of Norman (LION) | Norman | Oklahoma | 73069 | — |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | — |
| Oklahoma State University - Center for Health Sciences - Pediatric Research | Tulsa | Oklahoma | 74127 | — |
| Office of Richard Ohnmacht | Cranston | Rhode Island | 02920 | — |
| Omega Medical Research | Warwick | Rhode Island | 02886 | — |
| Radiant Research, Inc. | Anderson | South Carolina | 29621 | — |
| Charleston Pediatrics | Charleston | South Carolina | 29401 | — |
| PMG Research of Charleson | Mt. Pleasant | South Carolina | 29464 | — |
| Internal Medicine & Pediatric Associates of Bristol, PC | Bristol | Tennessee | 37620 | — |
| PMG Research of Bristol | Bristol | Tennessee | 37620 | — |
| Clinical Research Associates, Inc. | Nashville | Tennessee | 37203 | — |
| Tekton Research, Inc. | Austin | Texas | 78745 | — |
| Radiant Research, Inc. | Dallas | Texas | 75231 | — |
| Advances in Health Research, Inc | Houston | Texas | 77030 | — |
| West Houston Clinical Research Service | Houston | Texas | 77055 | — |
| Pediatric Healthcare of Northwest Houston | Houston | Texas | 77065 | — |
| Pediatric Healthcare of Northwest Houston | Houston | Texas | 77070 | — |
| Texas Center for Drug Development, Inc. | Houston | Texas | 77081 | — |
| Child Care Associates | San Antonio | Texas | 78212 | — |
| Clinical Trials of Texas, Inc. | San Antonio | Texas | 78229 | — |
| Radiant Research, Inc. | San Antonio | Texas | 78229 | — |
| First Steps Pediatrics | San Antonio | Texas | 78254 | — |
| Pediatric Healthcare of Northwest Houston, PA | Tomball | Texas | 77375 | — |
| Pediatric Healthcare of Northwest Houston | Tomball | Texas | 77375 | — |
| Radiant Research, Inc. | Murray | Utah | 84123 | — |
| J. Lewis Resarch Incorporated, Foothill Family Clinic | Salt Lake City | Utah | 84109 | — |
| J. Lewis Research Inc. - Foothill Family Clinic South | Salt Lake City | Utah | 84121 | — |
| Jean Brown Research | Salt Lake City | Utah | 84124 | — |
| J. Lewis Research, Inc. - Jordan River Family Medicine | South Jordan | Utah | 84095 | — |
| Advanced Clinical Research | West Jordan | Utah | 84088 | — |
| PI-Coor Clinical Research, LLC | Burke | Virginia | 22015 | — |
| Pediatric Associates of Charlottesville, PLC | Charlottesville | Virginia | 22902 | — |
| Pediatric Associates of Charlottesville, PLC - West Satellite | Charlottesville | Virginia | 22903 | — |
| Pediatric Associates of Charlottesville, PLC - North Satellite | Charlottesville | Virginia | 22911 | — |
| The Vancouver Clinic | Vancouver | Washington | 98664 | — |
| The Vancouver Clinic | Vancouver | Washington | 98686 | — |
| Gundersen Clinic, LTD | La Crosse | Wisconsin | 54601 | — |
| Monroe Clinic | 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 NCT01461980, 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 Dec 20, 2018 · Synced Oct 31, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01461980 live on ClinicalTrials.gov.