529
Participants
Start Date
November 30, 2009
Primary Completion Date
November 30, 2011
Study Completion Date
November 30, 2011
MenACWY-CRM
One dose (0.5 mL) of MenACWY conjugate vaccine supplied as an extemporaneous mixing just before injection of the lyophilized component (MenA) reconstituted with the liquid component (MenCWY) was administered at 2, 4, 6 and 12 months of age as IM injections in the anterolateral area of the thigh.
DTaP-IPV/Hib
IM injections of 3 doses of 0.5 mL each of DTaP-IPV/Hib supplied in prefilled vial were administered at 2, 4 and 6 months of age in the anterolateral area of the thigh.
HBV
IM injections of 3 doses of 0.5 mL each of HBV supplied in prefilled vial were administered at 2, 4 and 6 months of age in the anterolateral area of the thigh.
PCV
IM injections of 4 doses of 0.5 mL each of PCV supplied in prefilled vial were administered at 2, 4, 6 and 12 months of age in the anterolateral area of the thigh.
MMR
Subcutaneous (SC) injection of 1 dose of 0.5 mL of MMR obtained by extemporaneous mixing just before injection of powder and the solvent for solution was administered at 12 months of age in the anterolateral area of the thigh.
3 Sydney Children's Hospital Strasser Lab. Level 3 High Street, Randwick
1 Murdoch Childrens Research Institute C/- School of Population Health The University of Melbourne, Carlton
2 Royal Children's Hospital Herston Road, Herston
33 Primary Physicians Research Inc. 1580 McLaughlin Run Road, Pittsburgh
34 Primary Physicians Research Inc. 1580 McLaughlin Run Road, Pittsburgh
36 Dominion Medical Associates 304 East Leigh Street, Richmond
21 CAMC Health Education and Research Institute 3100 McCorkle Ave. S.E. Suite 806, Charleston
8 Pharmax Research Clinic 7200 NW 7th Street Suite 350, Miami
37 Alabama Clinical Therapeutics LLC 52 Medical Park East Drive Suite 203, Birmingham
23 Focus Research Group 201 Signature Place, Lebanon
10 Holston Medical Group 105 W. Stone Drive Suite 3B, Kingsport
29 Kentucky Pediatric/Adult Research 201 South 5th Street, Bardstown
30 Kentucky Pediatric/Adult Research 102 West Depot Street, Springfield
4 Nassim McMonigle Mescia and Associates 5512 Bardstown Road Suite 2, Louisville
40 Brownsboro Park Pediatrics 5512 Bardstown Road Suite 2, Louisville
24 University Of Louisville 555 South Floyd Street, Louisville
26 University Of Louisville 230 East Broadway, Louisville
5 Dayton Clinical Research 1100 Salem Ave., Dayton
22 Ohio Pediatrics Research Association 1775 Delco Park Drive, Kettering
14 Ohio Pediatrics Research Association 7371 Brandt Pike Suite C, Huber Heights
35 Southwestern Medical Clinic P.C. 2002 S 11th Street, Niles
25 Center for Pharmaceutical Research 1010 Carondelet Drive Suite 426, Kansas City
48 Cotton O'Neil Clinical Research Center 4100 SW 15th Street, Topeka
47 Cotton O'Neil Clinical Research Center 6725 SW 29th Street, Topeka
27 Ark-La-Tex Children's Clinic 1025 Highway 80 E, Haughton
13 Willis Knighton Physician Network- Portico Pediatrics 7847 Youree Drive, Shreveport
6 Children's Clinic of Jonesboro AR 800 South Church Street Suite 400 and 204, Jonesboro
15 Northwest Arkansas Pediatric Clinic 3383 N. Mana Court Suite 101, Fayetteville
45 Oklahoma State University Physicians 635 W 11th St, Tulsa
46 Pediatric Healthcare of Northwest Houston P.A. 12015 Louetta Road Suite 100, Houston
12 Pediatric Healthcare of Northwest Houston P.A. 13406 Medical Complex Drive Suite 200, Tomball
7 Amarillo Children's Clinical Research #17 Care Circle, Amarillo
16 Westside Medical 1477 North 2000 West, Clinton
42 Wee Care Pediatrics 934 S. Main Street Suite 8, Layton
43 Wee Care Pediatrics 1580 W. Antelope Drive Suite 100, Layton
44 Wee Care Pediatrics 5991 S. 3500 W Suite 100 Rock Run Plaza, Roy
41 Wee Care Pediatrics 1792 W. 1700 S. Suite 102, Syracuse
18 Copperview Medical Center 3556 West 9800 South, South Jordan
19 Pediatric Care 1675 North Freedom Blvd Building 3, Provo
39 Dixie Pediatrics 1240 E 100 S Suite 14, St. George
38 Center for Clinical Trials LLC 16660 Paramount Blvd Suite 301, Paramount
9 San Fernando Valley Research Associates 7111 Winnetka Avenue Suite 14, Canoga Park
28 Madera Family Medical Group 1111 West 4th Street, Madera
17 Edinger Medical Group Research Center 9900 Talbert Avenue Suite 204, Fountain Valley
31 Senders Pediatrics 2054 South Green Road, Cleveland
20 Medicor Research Inc 359 Riverside Suite 200, Greater Sudbury
Lead Sponsor
Novartis Vaccines
INDUSTRY