A Study to Evaluate the Safety and Immunogenicity of 4 Doses of MenACWY Conjugate Vaccine, Administered Concomitantly With Routine Vaccines, Among Infants Aged 2 Months
Public ClinicalTrials.gov record NCT01000311. 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, Open Label, Controlled Multicenter Study to Evaluate the Safety and Immunogenicity of 4 Doses of MenACWY Conjugate Vaccine, Administered Concomitantly With Routine Vaccines, Among Infants Aged 2 Months
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This Phase 3 study is designed to demonstrate the safety and immunogenicity of MenACWY and non-interference of concomitant routine vaccines by MenACWY in an infant age group.
Study identification
- NCT ID
- NCT01000311
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 529 participants
Conditions and interventions
Conditions
Interventions
- MenACWY-CRM Biological
- DTaP-IPV/Hib Biological
- HBV Biological
- PCV Biological
- MMR Biological
Biological
Eligibility (public fields only)
- Age range
- 55 Days to 89 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
- Oct 31, 2009
- Primary completion
- Oct 31, 2011
- Completion
- Oct 31, 2011
- Last update posted
- Apr 20, 2014
2009 – 2011
United States locations
- U.S. sites
- 42
- U.S. states
- 17
- U.S. cities
- 36
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 37 Alabama Clinical Therapeutics LLC 52 Medical Park East Drive Suite 203 | Birmingham | Alabama | 35235 | — |
| 15 Northwest Arkansas Pediatric Clinic 3383 N. Mana Court Suite 101 | Fayetteville | Arkansas | 72703 | — |
| 6 Children's Clinic of Jonesboro AR 800 South Church Street Suite 400 and 204 | Jonesboro | Arkansas | 72401 | — |
| 9 San Fernando Valley Research Associates 7111 Winnetka Avenue Suite 14 | Canoga Park | California | 91306 | — |
| 17 Edinger Medical Group Research Center 9900 Talbert Avenue Suite 204 | Fountain Valley | California | 92708-5153 | — |
| 28 Madera Family Medical Group 1111 West 4th Street | Madera | California | 93637 | — |
| 38 Center for Clinical Trials LLC 16660 Paramount Blvd Suite 301 | Paramount | California | 90723 | — |
| 8 Pharmax Research Clinic 7200 NW 7th Street Suite 350 | Miami | Florida | 33126 | — |
| 48 Cotton O'Neil Clinical Research Center 4100 SW 15th Street | Topeka | Kansas | 66604 | — |
| 47 Cotton O'Neil Clinical Research Center 6725 SW 29th Street | Topeka | Kansas | 66614 | — |
| 29 Kentucky Pediatric/Adult Research 201 South 5th Street | Bardstown | Kentucky | 40004 | — |
| 4 Nassim McMonigle Mescia and Associates 5512 Bardstown Road Suite 2 | Louisville | Kentucky | 40291 | — |
| 40 Brownsboro Park Pediatrics 5512 Bardstown Road Suite 2 | Louisville | Kentucky | 40291 | — |
| 24 University Of Louisville 555 South Floyd Street | Louisville | Kentucky | 40402 | — |
| 26 University Of Louisville 230 East Broadway | Louisville | Kentucky | 40402 | — |
| 30 Kentucky Pediatric/Adult Research 102 West Depot Street | Springfield | Kentucky | 40069 | — |
| 27 Ark-La-Tex Children's Clinic 1025 Highway 80 E | Haughton | Louisiana | 71037 | — |
| 13 Willis Knighton Physician Network- Portico Pediatrics 7847 Youree Drive | Shreveport | Louisiana | 71105 | — |
| 35 Southwestern Medical Clinic P.C. 2002 S 11th Street | Niles | Michigan | 49120 | — |
| 25 Center for Pharmaceutical Research 1010 Carondelet Drive Suite 426 | Kansas City | Missouri | 64114 | — |
| 31 Senders Pediatrics 2054 South Green Road | Cleveland | Ohio | 44121-4243 | — |
| 5 Dayton Clinical Research 1100 Salem Ave. | Dayton | Ohio | 45406 | — |
| 14 Ohio Pediatrics Research Association 7371 Brandt Pike Suite C | Huber Heights | Ohio | 45424 | — |
| 22 Ohio Pediatrics Research Association 1775 Delco Park Drive | Kettering | Ohio | 45420 | — |
| 45 Oklahoma State University Physicians 635 W 11th St | Tulsa | Oklahoma | 74127 | — |
| 33 Primary Physicians Research Inc. 1580 McLaughlin Run Road | Pittsburgh | Pennsylvania | 15241 | — |
| 34 Primary Physicians Research Inc. 1580 McLaughlin Run Road | Pittsburgh | Pennsylvania | 15241 | — |
| 10 Holston Medical Group 105 W. Stone Drive Suite 3B | Kingsport | Tennessee | 37660 | — |
| 23 Focus Research Group 201 Signature Place | Lebanon | Tennessee | 37087 | — |
| 7 Amarillo Children's Clinical Research #17 Care Circle | Amarillo | Texas | 79124 | — |
| 46 Pediatric Healthcare of Northwest Houston P.A. 12015 Louetta Road Suite 100 | Houston | Texas | 77070 | — |
| 12 Pediatric Healthcare of Northwest Houston P.A. 13406 Medical Complex Drive Suite 200 | Tomball | Texas | 77375 | — |
| 16 Westside Medical 1477 North 2000 West | Clinton | Utah | 84015 | — |
| 42 Wee Care Pediatrics 934 S. Main Street Suite 8 | Layton | Utah | 84041 | — |
| 43 Wee Care Pediatrics 1580 W. Antelope Drive Suite 100 | Layton | Utah | 84041 | — |
| 19 Pediatric Care 1675 North Freedom Blvd Building 3 | Provo | Utah | 84604 | — |
| 44 Wee Care Pediatrics 5991 S. 3500 W Suite 100 Rock Run Plaza | Roy | Utah | 84067 | — |
| 18 Copperview Medical Center 3556 West 9800 South | South Jordan | Utah | 84095 | — |
| 39 Dixie Pediatrics 1240 E 100 S Suite 14 | St. George | Utah | 84790 | — |
| 41 Wee Care Pediatrics 1792 W. 1700 S. Suite 102 | Syracuse | Utah | 84075 | — |
| 36 Dominion Medical Associates 304 East Leigh Street | Richmond | Virginia | 23219 | — |
| 21 CAMC Health Education and Research Institute 3100 McCorkle Ave. S.E. Suite 806 | Charleston | West Virginia | 25304 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01000311, 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 20, 2014 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01000311 live on ClinicalTrials.gov.