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Completed Phase 3 Interventional Accepts healthy volunteers Results available

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.

ClinicalTrials.gov public records Last synced May 6, 2026, 8:14 AM EDT

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

Study identification

NCT ID
NCT00806195
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Novartis
Industry
Enrollment
7,744 participants

Conditions and interventions

Interventions

  • DTaP (Diptheria, Tetanus, Pertussis) Vaccine Biological
  • Hepatitis A Virus Biological
  • Hib (Haemophilus influenza b) Vaccine Biological
  • IPV (Inactivated Polio Vaccine) Vaccine Biological
  • MMR (Measles, Mumps, and Rubella) Vaccine Biological
  • MenACWY-CRM197 Biological
  • Pneumococcal conjugate Vaccine Biological
  • Varicella Vaccine 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
Nov 30, 2008
Primary completion
Feb 28, 2011
Completion
Oct 31, 2011
Last update posted
Jul 8, 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 8, 2013 · Synced May 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00806195 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →