ClinicalTrials.gov record
Study to Evaluate the Safety of Novartis MenACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants
ClinicalTrials.gov ID: NCT00806195
Public ClinicalTrials.gov record NCT00806195. 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 3b, Open-Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Safety of Novartis MenACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of this phase 3b study is to evaluate the safety and tolerability of Novartis MenACWY conjugate vaccine when administered with routine infant vaccinations to healthy infants
Study identification
- NCT ID
- NCT00806195
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 7,744 participants
Conditions and interventions
Conditions
Interventions
- MenACWY-CRM197 Biological
- DTaP (Diptheria, Tetanus, Pertussis) Vaccine Biological
- Hib (Haemophilus influenza b) Vaccine Biological
- IPV (Inactivated Polio Vaccine) Vaccine Biological
- Pneumococcal conjugate Vaccine Biological
- MMR (Measles, Mumps, and Rubella) Vaccine Biological
- Varicella Vaccine Biological
- Hepatitis A Virus 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
- Dec 2008 (Type not available)
- Primary completion
- Mar 2011 (Actual)
- Completion
- Nov 2011 (Actual)
- Last update posted
- Jul 9, 2013
2008 – 2011
United States locations
- U.S. sites
- 130
- U.S. states
- 31
- U.S. cities
- 110
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 6 Alabama Clinical Therapeutics 806 St. Vincent's Drive, Ste 615 | Birmingham | Alabama | 35205 | — |
| 43 Alabama Clinical Therapeutics, LLC 364 Honeysuckle Rd | Dothan | Alabama | 36305 | — |
| 81 Cholla Pediatrics 2167 West Orange Grove Road | Tuscon | Arizona | 85741 | — |
| 55 Central Arkansas Pediatric Clinic Pediatric 2301 Springhill Road Suite 200 | Benton | Arkansas | 72019 | — |
| 21 Northwest Arkansas Pediatric Clinic 3383 N. MANA Court Suite 101 | Fayetteville | Arkansas | 72703 | — |
| 30 Sparks Pediatric Clinic 1501 S. Waldron Road Suite 100 | Fort Smith | Arkansas | 72903 | — |
| 14 The Children's Clinic of Jonesboro 800 S. Church Suite 400 | Jonesboro | Arkansas | 72401 | — |
| 170 Little Rock Children's Clinic P.A. 9600 Lile Dr., Ste 360 | Little Rock | Arkansas | 72205 | — |
| 3 Arkansas Pediatric Clinic 500 S. University Suite 200 | Little Rock | Arkansas | 72205 | — |
| 179 Associated Pharmaceutical Research Center, Inc 8615 Knott Avenue Suite 5 | Buena Park | California | 90620 | — |
| 160 San Fernando Valley Research Associates, Inc. 7111 Winnetka Ave. #14 | Canoga Park | California | 91306 | — |
| 157 Universal Biopharma Research Institute Inc./Alta Family Health Clinic 888 N. Alta Ave. | Dinuba | California | 93618 | — |
| 1 Premier Health Research Center, LLC 11525 Brookshire Ave Suite 400 | Downey | California | 90241-4982 | — |
| 68 Sierra Medical Research 5150 N. Sixth, Suite 156 | Fresno | California | 93710 | — |
| 129 Citrus Vally Family Practice 1400 Hacienda Blvd | La Puente | California | 91744 | — |
| 114 Loma Linda University Health 11175 Campus Street Coleman Pavillion A-1120 | Loma Linda | California | 92354 | — |
| 59 Loma Linda University Health 11175 Campus Street Coleman Pavillion A-1120 | Loma Linda | California | 92354 | — |
| 153 Health Care Partners Medical Group Health Care Partners Medical Group 4401 Atlantic Ave. | Long Beach | California | 90807 | — |
| 94 Health Care Partners Medical Group 1025 W. Olympic Blvd. | Los Angeles | California | 90015 | — |
| 67 Madera Family Medical Group 1111 West 4th Street | Madera | California | 93637 | — |
| 121 Kaiser Permanente (Oakland) 3505 Broadway 6th floor | Oakland | California | 94611 | — |
| 63 Kaiser Permanente Vaccine Study Center One Kaiser Plaza 16th Floor | Oakland | California | 94611 | — |
| 42 Children's Hospital of Orange County 455 S. Main Street | Orange | California | 92868 | — |
| 12 Center For Clinical Trials, LLC. 16660 Paramount Blvd Suite 301 | Paramount | California | 90723 | — |
| 122 Kaiser Permanente (Pleasanton) 7601 Stoneridge Drive, MOB North 2nd Floor | Pleasanton | California | 94588 | — |
| 57 UC Davis Medical Center 2516 Stockton Blvd Ticon II | Sacramento | California | 95817 | — |
| 123 Kaiser Permanente (San Francisco) 2200 O'Farrell Street 6th floor room 636 | San Francisco | California | 94115 | — |
| 166 Buena Salud Pediatrics 2880 Story Road | San Jose | California | 95127 | — |
| 20 White Memorial Pediatric Medical Group UCLA Center for Vaccine Research 1124 West Carson Street Liu Research Building (Room 132) | Torrance | California | 90502 | — |
| 152 Health Care Partners Medical Group 3565 Del Amo Blvd Research Dept. | Torrance | California | 90503 | — |
| 40 Center for Clinical Trials of San Gabriel 1300 S Sunset Avenue Suite 101 | West Covina | California | 91790 | — |
| 54 1st International Research Centers 10370 Steeke Street | Thornton | Colorado | 80229 | — |
| 29 Norwich Pediatric Group 92 New London Turnpike | Norwich | Connecticut | 06360 | — |
| 99 Altamonte Pediatric Associates 101 N Country Club Rd. | Lake Mary | Florida | 32746 | — |
| 60 Orlando Health Pediatric Faculty Practice 32 West Sturtevant St, MP-141 | Orlando | Florida | 32806 | — |
| 34 Pediatric Partners Pediatrics 3401 PGA Blvd Ste 300 | Palm Beach Gardens | Florida | 33410 | — |
| 88 Physician Care Clinical Research 1918 Robinhood Street | Sarasota | Florida | 34231 | — |
| 162 North Georgia Clinical Research Center 1575 Chattanooga Avenue Suite 1 | Dalton | Georgia | 30721 | — |
| 11 Pediatrics and Adolescent Medicine, PA 2155 Post Oak Tritt Road Suite 100 | Marietta | Georgia | 30062 | — |
| 101 Pediatrics and Adolescent Medicine, PA 120 Stonebridge Parkway, Suite 410 | Woodstock | Georgia | 30189 | — |
| 132 Kaiser Permanente Pediatric - Mapunapuna 2828 Paa Street, 2nd Floor | Honolulu | Hawaii | 96819 | — |
| 131 Kaiser Permanente Waipio 1st Floor 94-1480 Moaniani Street | Waipahu | Hawaii | 96797 | — |
| Northern Illinois Research Associates 625 E. Bethany Ste. 3 | DeKalb | Illinois | 60115 | — |
| 95 Heartland Research Associates 510 West Radio Lane | Arkansas City | Kansas | 67005 | — |
| 92 Heartland Research Associates LLC 700 Medical Center Dr. Suite 210 | Newton | Kansas | 67114 | — |
| 178 Pediatric Care 6725 Southwest Twenty-Ninth Street | Topeka | Kansas | 66614 | — |
| 51 Kentucky Pediatric/Adult Research 201 S. 5th Street | Bardstown | Kentucky | 40004 | — |
| 84 Michael W. Simon M.D. 185 Pasadena Drive Suite 220 | Lexington | Kentucky | 40503 | — |
| 106 University Child Health Specialists 230 East Broadway | Louisville | Kentucky | 40202 | — |
| 24 Bluegrass Clinical Research, Inc 5512 Bardstown Road Suite 2 | Louisville | Kentucky | 40291 | — |
| 76 Bluegrass Clinical Research, Inc 5512 Bardstown Road Suite2 | Louisville | Kentucky | 40291 | — |
| 15 University of Louisville 571 South Floyd Suite 321 L | Ouisville | Kentucky | 40202 | — |
| 108 Physicians to Children and Adolescents 102 West Depot Street | Springfield | Kentucky | 40069 | — |
| 86 Willis-Knighton Physician Network 7847 Youree Drive | Shreveport | Louisiana | 71105 | — |
| 22 Roslindale Pediatric Assoc, P.C 1153 Centre St Suite 31 | Boston | Massachusetts | 02130 | — |
| 23 Pediatric Associates of Fall River 829 South Main Street | Fall River | Massachusetts | 02724 | — |
| 126 North Andover Pediatrics Associates 800 Turnpike Street | North Andover | Massachusetts | 01845 | — |
| 9 Woburn Pediatric Associates 7 Alfred Street Baldwin Park II | Woburn | Massachusetts | 01801 | — |
| 168 Southwestern Medical Clinic 2002 South 11th Street | Niles | Michigan | 49120 | — |
| 26 Southwestern Medical Clinic 5515 Cleveland Avenue Suite 1 | Stevensville | Michigan | 49127 | — |
| 89 Aspen Medical Group 1020 Bandana Blvd West Ste 214 | Saint Paul | Minnesota | 55108 | — |
| 80 Craig A. Spiegel, M.D 12255 DePaul Drive Sutie 380 | Bridgeton | Missouri | 63044 | — |
| 69 Clinical Research Center of Nevada 1012 East Sahara Avenue | Las Vegas | Nevada | 89104 | — |
| 173 Maimonides Medical Center 948 48th Street 1st Floor | Brooklyn | New York | 11219 | — |
| 70 Summer Pediatrics 4811 Buckley Road | Liverpool | New York | 13088 | — |
| 16 Winthrop University Hospital Department of Pediatrics 120 Mineola Blvd Suite 210 | Mineola | New York | 11501 | — |
| 77 SUNY Upstate Medical University 750 East Adams Street Suite 5400 | Syracuse | New York | 13210 | — |
| 56 Cary Pediatrics 1001 Crescent Green Dr. | Cary | North Carolina | 27511 | — |
| 103 Durham Pediatrics 2609 North Duke Street, Suite 1000 | Durham | North Carolina | 27704 | — |
| 104 Regional Pediatrics 4022 Freedom Lake Drive | Durham | North Carolina | 27704 | — |
| 13 Duke Health Center 4020 N. Roxboro Road | Durham | North Carolina | 27704 | — |
| 48 Capitol Pediatrics and Adolescent Center 3801 Computer Drive Suite 200 | Raleigh | North Carolina | 27609 | — |
| 91 Triangle Medical Research 5816 Creedmoor Rd. Suite 104 | Raleigh | North Carolina | 27612 | — |
| 73 Piedmont Medical Research Assoc 1901 S Hawthorne Rd Ste 306 | Winston-Salem | North Carolina | 27103 | — |
| 87 Innovis Health 1702 South University Drive Suite 1 | Fargo | North Dakota | 58103 | — |
| 97 Children's Hospital Medical Center of Akron One Perkins Square | Akron | Ohio | 44308 | — |
| 120 Akron Children's Hospital Pediatrics 62 Conservatory Drive, #A | Barberton | Ohio | 44203 | — |
| 36 Dr. Senders and Associates, Pediatrics 2054 South Green Road | Cleveland | Ohio | 44121 | — |
| 79 Dayton Clinical Research 1100 Salem Ave | Dayton | Ohio | 45406 | — |
| 37 Pediatric Associates of Fairfield, Inc. 5900 Boymel Drive | Fairfield | Ohio | 45014 | — |
| 4 Ohio Pediatrics, INC 7371 Brandt Pike Suite C | Huber Heights | Ohio | 45424-3200 | — |
| 102 Ohio Pediatrics, INC 1775 Delco Park Drive | Kettering | Ohio | 45420 | — |
| 28 Pediatric Associates of Youngstown 4308 Belmont Avenue | Youngstown | Ohio | 44505 | — |
| 100 Pediatric Associates of Youngstown 727 East Western Reserve Road | Youngstown | Ohio | 44514 | — |
| 25 Oklahoma State University-CHS C/O Pediatrics 635 West 11th Street | Tulsa | Oklahoma | 74127 | — |
| 83 The Portland Clinic LLP 15950 SW Millikan Lane Research Dept. | Beaverton | Oregon | 97006 | — |
| 7 Cyn3rgy Research 24850 SE Stark Street Suite 180 | Gresham | Oregon | 97030 | — |
| 113 Children's Health Care-West 4671 West Lake Road | Erie | Pennsylvania | 16505 | — |
| 109 UPMC/Community Medicine Inc. 90 Shenango Street | Greenville | Pennsylvania | 16125 | — |
| 107 Pennridge Pediatric Associates 270 Main Street | Harleysville | Pennsylvania | 19438 | — |
| 110 Pediatric Alliance Southwestern - Squirrel Hill 4070 Beechwood Blvd | Pittsburgh | Pennsylvania | 15217 | — |
| 112 Pediatric Alliance, Southwestern 850 Clairton Blvd | Pittsburgh | Pennsylvania | 15236 | — |
| 118 Pediatric Alliance, PC Arcadia Division 9000 Perry Highway Suite 120 | Pittsburgh | Pennsylvania | 15237 | — |
| 5 Primary Physicians Research, Inc 1580 McLaughlin Run Road | Pittsburgh | Pennsylvania | 15241 | — |
| 49 Pennridge Pediatric Associates 711 Lawn Avenue | Sellersville | Pennsylvania | 18960 | — |
| 41 Palmetto Pediatrics, PA Pediatrics 2781 Tricom Street | Charleston | South Carolina | 29406 | — |
| 71 Holston Medical Group 105 W. Stone Dr. Suite 2A | Kingsport | Tennessee | 37660 | — |
| 72 Holston Medical Group 2033 Meadowview Lane | Kingsport | Tennessee | 37660 | — |
| 165 Focus Research Group 201 Signature Place Suite C | Lebanon | Tennessee | 37087 | — |
| 52 Heritage Medical Associates 2325 Crestmoor Road | Nashville | Tennessee | 37215 | — |
| 90 Premier Medical Group Alpha Clinical Research 279 Clear Sky Court | Ste C Clarksville | Tennessee | 37043 | — |
| 64 Amarillo Childrens Clinical Research #17 Care Circle | Amarillo | Texas | 79124 | — |
| 19 University of North Texas Health Science Center 3500 Camp Bowie Blvd | Fort Worth | Texas | 76107 | — |
| 175 Sealy Center for Vaccine Development, Clinical Trials 301 University Blvd. Children's Hospital Room 3.270F L#20412 | Galveston | Texas | 77555-0351 | — |
| 96 West Houston Clinical Research Service 2026 Wirt Road | Houston | Texas | 77055 | — |
| 50 San Antonio Metropolitan Health District 332 West Commerce Room 307 | San Antonio | Texas | 78205 | — |
| 31 Southwest Children's Research Associates, P. A. 5282 Medical Drive Suite 311 | San Antonio | Texas | 78229 | — |
| 47 Dynamed Clinical Research 13406 Medical Complex Dr Suite 200 | Tomball | Texas | 77375 | — |
| 75 Pediatric Care 1596 S. 500 W., 1st Floor | Bountiful | Utah | 84010 | — |
| 82 Dixie Pediatrics 1240 E 100 S STE 14 St. | George | Utah | 84790 | — |
| 115 Wee Care(Layton) 1580 West Antelope Drive | Layton | Utah | 84041 | — |
| 116 Wee Care(Kaysville) 934 South Main Street, Suite 8 | Layton | Utah | 84041 | — |
| 181 Jean Brown Research 164 East 5900 South Suite A-112 | Murray | Utah | 84107 | — |
| 74 Utah Valley Pediatrics North University 7407 North Cedar St. | Provo | Utah | 84604 | — |
| 117 Wee Care(Roy) 5991 South 3500 West, Suite 100 | Roy | Utah | 84067 | — |
| 66 J. Lewis Research Inc. 2295 Foothill Drive | Salt Lake City | Utah | 84109 | — |
| 61 Foothill Family Clinic South 6360 South 300 East Suite 100 | Salt Lake City | Utah | 84121 | — |
| 151 Family First Pediatrics c/o Pharmaceutical Research Organization 1268 W. South Jordan Parkway Suite 201 | South Jordan | Utah | 84095 | — |
| 44 Wee Care Pediatrics (Syracuse) 1792 West 1700 South Suite 102 | Syracuse | Utah | 84075 | — |
| Jordan Ridge Kids & Teens 8822 S. Redwood Road Suite S103 | West Jordan | Utah | 84088 | — |
| 85 Pediatric Research of Charlottesville, LLC 1011 East Jefferson St. Suite 3 | Charlottesville | Virginia | 22902 | — |
| 158 Huguenot Pediatrics, PC 1407 Huguenot Rd. | Midlothian | Virginia | 23113 | — |
| 46 Virginia Commonwealth University 1001 East Marshall Street P008 | Richmond | Virginia | 23219 | — |
| 93 Advanced Pediatrics 100 East Street SE Suite 301 | Vienna | Virginia | 22180 | — |
| 2 Rockwood Clinical Research Center 400 East Fifth Avenue | Spokane | Washington | 99202 | — |
| 38 Rockwood Clinic, P.S. 9001 N. Country Homes Blvd. | Spokane | Washington | 99218 | — |
| 124 The Vancouver Clinic/NE 87th Avenue 700 NE 87th Avenue | Vancouver | Washington | 98664 | — |
| 125 The Vancouver Clinic/Columbia Tech Center 501 SE 172th Avenue | Vancouver | Washington | 98684 | — |
| 167 The Vancouver Clinic/Salmon Creek 2525 NE 139th Street | Vancouver | Washington | 98686 | — |
| 163 Wenatchee Valley Medical Center Clinical Research Department 820 North Chelan Avenue | Wenatchee | Washington | 98801 | — |
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 23 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00806195, 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 Jul 9, 2013 · Synced Oct 21, 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 NCT00806195 live on ClinicalTrials.gov.