Study to Evaluate the Safety of Novartis MenACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants
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
1 other identifier
interventional
7,744
6 countries
153
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2008
Typical duration for phase_3
153 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 9, 2008
CompletedFirst Posted
Study publicly available on registry
December 10, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedResults Posted
Study results publicly available
July 9, 2013
CompletedJuly 9, 2013
May 1, 2013
2.2 years
December 9, 2008
May 13, 2013
May 13, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentages of Subjects With At Least One Severe Systemic Reaction After Any Vaccination
To compare the percentages of subjects who reported at least one severe systemic reaction after any vaccination of MenACWY-CRM197 (detailed) plus routine vaccines (detailed) group to that observed in the routine vaccines alone (detailed) group administered at 2, 4, 6, and 12 months of age. Detailed - infants who provided reactogenicity and all Adverse Events (AEs) for 7 days, Serious Adverse Events (SAEs) and medically attended AEs.
15 minutes to Day 7 after any vaccination administered at 2, 4, 6 and 12 months of age
Secondary Outcomes (3)
Percentages of Subjects With At Least One Serious Adverse Event During the Entire Study Period
Day 1 (2 months of age) to 18 months of age
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination
15 minutes to Day 7
Number of Subjects Who Reported Unsolicited Adverse Events After Any Vaccination
Day 1 (2 months of age) to 18 months of age
Study Arms (6)
MenACWY-CRM197 + Routine Vaccines (Non-Detailed)
EXPERIMENTALInfants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR: 12 months. Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines. Non-Detailed - infants who only provided SAEs (Serious Adverse Events) and medically attended AEs (Adverse Events).
Routine Vaccines (Non-Detailed)
ACTIVE COMPARATORInfants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR: 12 months. Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines. Non-Detailed - subjects who only provided SAEs and medically attended AEs.
MenACWY-CRM197 + Routine Vaccines (Detailed)
EXPERIMENTALInfants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life. Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines. Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs.
Routine Vaccines (Detailed)
ACTIVE COMPARATORInfants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life. Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines. Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs.
MenACWY-CRM197 + Routine Vaccines (All)
EXPERIMENTALInfants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life. Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines. All (Detailed and Non-Detailed subjects): Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - subjects who only provided SAEs and medically attended AEs.
Routine Vaccines (All)
ACTIVE COMPARATORInfants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life. Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines. All (Detailed and Non-Detailed subjects): Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - subjects who only provided SAEs and medically attended AEs.
Interventions
Four 0.5mL vaccinations of MenACWY-CRM197 conjugate vaccine was administered by intramuscular injection at 2, 4, 6 and 12 months of age.
Four vaccinations of DTaP (Diptheria, Tetanus, Pertussis) was administered at 2, 4, 6, and 15 months of age.
Four vaccinations of Hib (Haemophilus influenza b) vaccine was administered at 2, 4, 6 and 15 months of age.
Three vaccinations of IPV (Inactivated Polio Vaccine) was administered at 2, 4, and 6 months of age.
Four vaccinations of Pneumococcal conjugate vaccine was administered at 2, 4, 6 and 12 months of age.
One vaccination of MMR (Measles, Mumps, and Rubella) was administered at 12 months of age.
One vaccination of Varicella vaccine was administered at 12 months of age.
One vaccination of Hepatitis A Virus vaccine was administered at 12 months of age.
Eligibility Criteria
You may qualify if:
- healthy 2-month-old infants (aged 55 - 89 days); babies must have been born after a full-term pregnancy with an estimated gestation age ≥37 weeks and a birth weight ≥2.5 kg
- for whom a parent/legal representative has given written informed consent after the nature of the study has been explained;
- who are available for all visits scheduled in the study;
- who are in good health as determined by medical history and physical assessment.
You may not qualify if:
- who previously received any meningococcal vaccine or D, T, P, IPV or OPV, H influenzae type b (Hib) or Pneumococcus; prior doses of BCG (one) and/or HBV (two) are permitted
- who have a previous confirmed or suspected disease caused by N meningitidis, C diphtheriae, C tetani, Poliovirus, Hepatitis B, Hib, Pneumococcus or B pertussis (history of laboratory confirmed, or clinical condition of paroxysmal cough for a period of longer than or equal to 2 weeks associated with apnea or whooping);
- who have had household contact with and/or intimate exposure to an individual with laboratory confirmed N meningitidis (serogroups A, C, W135, or Y), B pertussis, Hib, C diphtheriae, Polio, or pneumococcal infection at any time since birth;
- who have a history of anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component;
- who have experienced significant acute or chronic infection within the previous 7 days or have experienced fever (axillary temperature ≥ 38.0°C \[100.4°F\]) within the previous 3 days;
- who have any present or suspected serious acute (e.g. leukemia, lymphomas), or chronic disease (e.g., with signs of cardiac disease, renal failure, severe malnutrition, or insulin dependent diabetes), or progressive neurological disease, or a genetic anomaly/known cytogenic disorders (e.g., Down's syndrome);
- who have a known or suspected autoimmune disease or persistent impairment/alteration of immune function resulting from (for example):
- receipt of any immunosuppressive therapy at any time since birth
- receipt of immunostimulants at any time since birth
- receipt of any systemic corticosteroid since birth;
- who have a suspected or known HIV infection or HIV related disease;
- who have ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation;
- who have a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;
- who have any history of seizure;
- who with their parents/legal representatives are planning to leave the area of the study site before the end of the study period;
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
- Novartis Vaccinescollaborator
Study Sites (153)
6 Alabama Clinical Therapeutics 806 St. Vincent's Drive, Ste 615
Birmingham, Alabama, 35205, United States
43 Alabama Clinical Therapeutics, LLC 364 Honeysuckle Rd
Dothan, Alabama, 36305, United States
81 Cholla Pediatrics 2167 West Orange Grove Road
Tuscon, Arizona, 85741, United States
55 Central Arkansas Pediatric Clinic Pediatric 2301 Springhill Road Suite 200
Benton, Arkansas, 72019, United States
21 Northwest Arkansas Pediatric Clinic 3383 N. MANA Court Suite 101
Fayetteville, Arkansas, 72703, United States
30 Sparks Pediatric Clinic 1501 S. Waldron Road Suite 100
Fort Smith, Arkansas, 72903, United States
14 The Children's Clinic of Jonesboro 800 S. Church Suite 400
Jonesboro, Arkansas, 72401, United States
170 Little Rock Children's Clinic P.A. 9600 Lile Dr., Ste 360
Little Rock, Arkansas, 72205, United States
3 Arkansas Pediatric Clinic 500 S. University Suite 200
Little Rock, Arkansas, 72205, United States
179 Associated Pharmaceutical Research Center, Inc 8615 Knott Avenue Suite 5
Buena Park, California, 90620, United States
160 San Fernando Valley Research Associates, Inc. 7111 Winnetka Ave. #14
Canoga Park, California, 91306, United States
157 Universal Biopharma Research Institute Inc./Alta Family Health Clinic 888 N. Alta Ave.
Dinuba, California, 93618, United States
1 Premier Health Research Center, LLC 11525 Brookshire Ave Suite 400
Downey, California, 90241-4982, United States
68 Sierra Medical Research 5150 N. Sixth, Suite 156
Fresno, California, 93710, United States
129 Citrus Vally Family Practice 1400 Hacienda Blvd
La Puente, California, 91744, United States
114 Loma Linda University Health 11175 Campus Street Coleman Pavillion A-1120
Loma Linda, California, 92354, United States
59 Loma Linda University Health 11175 Campus Street Coleman Pavillion A-1120
Loma Linda, California, 92354, United States
153 Health Care Partners Medical Group Health Care Partners Medical Group 4401 Atlantic Ave.
Long Beach, California, 90807, United States
94 Health Care Partners Medical Group 1025 W. Olympic Blvd.
Los Angeles, California, 90015, United States
67 Madera Family Medical Group 1111 West 4th Street
Madera, California, 93637, United States
121 Kaiser Permanente (Oakland) 3505 Broadway 6th floor
Oakland, California, 94611, United States
63 Kaiser Permanente Vaccine Study Center One Kaiser Plaza 16th Floor
Oakland, California, 94611, United States
42 Children's Hospital of Orange County 455 S. Main Street
Orange, California, 92868, United States
12 Center For Clinical Trials, LLC. 16660 Paramount Blvd Suite 301
Paramount, California, 90723, United States
122 Kaiser Permanente (Pleasanton) 7601 Stoneridge Drive, MOB North 2nd Floor
Pleasanton, California, 94588, United States
57 UC Davis Medical Center 2516 Stockton Blvd Ticon II
Sacramento, California, 95817, United States
123 Kaiser Permanente (San Francisco) 2200 O'Farrell Street 6th floor room 636
San Francisco, California, 94115, United States
166 Buena Salud Pediatrics 2880 Story Road
San Jose, California, 95127, United States
20 White Memorial Pediatric Medical Group UCLA Center for Vaccine Research 1124 West Carson Street Liu Research Building (Room 132)
Torrance, California, 90502, United States
152 Health Care Partners Medical Group 3565 Del Amo Blvd Research Dept.
Torrance, California, 90503, United States
40 Center for Clinical Trials of San Gabriel 1300 S Sunset Avenue Suite 101
West Covina, California, 91790, United States
54 1st International Research Centers 10370 Steeke Street
Thornton, Colorado, 80229, United States
29 Norwich Pediatric Group 92 New London Turnpike
Norwich, Connecticut, 06360, United States
99 Altamonte Pediatric Associates 101 N Country Club Rd.
Lake Mary, Florida, 32746, United States
60 Orlando Health Pediatric Faculty Practice 32 West Sturtevant St, MP-141
Orlando, Florida, 32806, United States
34 Pediatric Partners Pediatrics 3401 PGA Blvd Ste 300
Palm Beach Gardens, Florida, 33410, United States
88 Physician Care Clinical Research 1918 Robinhood Street
Sarasota, Florida, 34231, United States
162 North Georgia Clinical Research Center 1575 Chattanooga Avenue Suite 1
Dalton, Georgia, 30721, United States
11 Pediatrics and Adolescent Medicine, PA 2155 Post Oak Tritt Road Suite 100
Marietta, Georgia, 30062, United States
101 Pediatrics and Adolescent Medicine, PA 120 Stonebridge Parkway, Suite 410
Woodstock, Georgia, 30189, United States
132 Kaiser Permanente Pediatric - Mapunapuna 2828 Paa Street, 2nd Floor
Honolulu, Hawaii, 96819, United States
131 Kaiser Permanente Waipio 1st Floor 94-1480 Moaniani Street
Waipahu, Hawaii, 96797, United States
Northern Illinois Research Associates 625 E. Bethany Ste. 3
DeKalb, Illinois, 60115, United States
95 Heartland Research Associates 510 West Radio Lane
Arkansas City, Kansas, 67005, United States
92 Heartland Research Associates LLC 700 Medical Center Dr. Suite 210
Newton, Kansas, 67114, United States
178 Pediatric Care 6725 Southwest Twenty-Ninth Street
Topeka, Kansas, 66614, United States
51 Kentucky Pediatric/Adult Research 201 S. 5th Street
Bardstown, Kentucky, 40004, United States
84 Michael W. Simon M.D. 185 Pasadena Drive Suite 220
Lexington, Kentucky, 40503, United States
106 University Child Health Specialists 230 East Broadway
Louisville, Kentucky, 40202, United States
24 Bluegrass Clinical Research, Inc 5512 Bardstown Road Suite 2
Louisville, Kentucky, 40291, United States
76 Bluegrass Clinical Research, Inc 5512 Bardstown Road Suite2
Louisville, Kentucky, 40291, United States
15 University of Louisville 571 South Floyd Suite 321 L
Ouisville, Kentucky, 40202, United States
108 Physicians to Children and Adolescents 102 West Depot Street
Springfield, Kentucky, 40069, United States
86 Willis-Knighton Physician Network 7847 Youree Drive
Shreveport, Louisiana, 71105, United States
22 Roslindale Pediatric Assoc, P.C 1153 Centre St Suite 31
Boston, Massachusetts, 02130, United States
23 Pediatric Associates of Fall River 829 South Main Street
Fall River, Massachusetts, 02724, United States
126 North Andover Pediatrics Associates 800 Turnpike Street
North Andover, Massachusetts, 01845, United States
9 Woburn Pediatric Associates 7 Alfred Street Baldwin Park II
Woburn, Massachusetts, 01801, United States
168 Southwestern Medical Clinic 2002 South 11th Street
Niles, Michigan, 49120, United States
26 Southwestern Medical Clinic 5515 Cleveland Avenue Suite 1
Stevensville, Michigan, 49127, United States
89 Aspen Medical Group 1020 Bandana Blvd West Ste 214
Saint Paul, Minnesota, 55108, United States
80 Craig A. Spiegel, M.D 12255 DePaul Drive Sutie 380
Bridgeton, Missouri, 63044, United States
69 Clinical Research Center of Nevada 1012 East Sahara Avenue
Las Vegas, Nevada, 89104, United States
173 Maimonides Medical Center 948 48th Street 1st Floor
Brooklyn, New York, 11219, United States
70 Summer Pediatrics 4811 Buckley Road
Liverpool, New York, 13088, United States
16 Winthrop University Hospital Department of Pediatrics 120 Mineola Blvd Suite 210
Mineola, New York, 11501, United States
77 SUNY Upstate Medical University 750 East Adams Street Suite 5400
Syracuse, New York, 13210, United States
56 Cary Pediatrics 1001 Crescent Green Dr.
Cary, North Carolina, 27511, United States
103 Durham Pediatrics 2609 North Duke Street, Suite 1000
Durham, North Carolina, 27704, United States
104 Regional Pediatrics 4022 Freedom Lake Drive
Durham, North Carolina, 27704, United States
13 Duke Health Center 4020 N. Roxboro Road
Durham, North Carolina, 27704, United States
48 Capitol Pediatrics and Adolescent Center 3801 Computer Drive Suite 200
Raleigh, North Carolina, 27609, United States
91 Triangle Medical Research 5816 Creedmoor Rd. Suite 104
Raleigh, North Carolina, 27612, United States
73 Piedmont Medical Research Assoc 1901 S Hawthorne Rd Ste 306
Winston-Salem, North Carolina, 27103, United States
87 Innovis Health 1702 South University Drive Suite 1
Fargo, North Dakota, 58103, United States
97 Children's Hospital Medical Center of Akron One Perkins Square
Akron, Ohio, 44308, United States
120 Akron Children's Hospital Pediatrics 62 Conservatory Drive, #A
Barberton, Ohio, 44203, United States
36 Dr. Senders and Associates, Pediatrics 2054 South Green Road
Cleveland, Ohio, 44121, United States
79 Dayton Clinical Research 1100 Salem Ave
Dayton, Ohio, 45406, United States
37 Pediatric Associates of Fairfield, Inc. 5900 Boymel Drive
Fairfield, Ohio, 45014, United States
4 Ohio Pediatrics, INC 7371 Brandt Pike Suite C
Huber Heights, Ohio, 45424-3200, United States
102 Ohio Pediatrics, INC 1775 Delco Park Drive
Kettering, Ohio, 45420, United States
28 Pediatric Associates of Youngstown 4308 Belmont Avenue
Youngstown, Ohio, 44505, United States
100 Pediatric Associates of Youngstown 727 East Western Reserve Road
Youngstown, Ohio, 44514, United States
25 Oklahoma State University-CHS C/O Pediatrics 635 West 11th Street
Tulsa, Oklahoma, 74127, United States
83 The Portland Clinic LLP 15950 SW Millikan Lane Research Dept.
Beaverton, Oregon, 97006, United States
7 Cyn3rgy Research 24850 SE Stark Street Suite 180
Gresham, Oregon, 97030, United States
113 Children's Health Care-West 4671 West Lake Road
Erie, Pennsylvania, 16505, United States
109 UPMC/Community Medicine Inc. 90 Shenango Street
Greenville, Pennsylvania, 16125, United States
107 Pennridge Pediatric Associates 270 Main Street
Harleysville, Pennsylvania, 19438, United States
110 Pediatric Alliance Southwestern - Squirrel Hill 4070 Beechwood Blvd
Pittsburgh, Pennsylvania, 15217, United States
112 Pediatric Alliance, Southwestern 850 Clairton Blvd
Pittsburgh, Pennsylvania, 15236, United States
118 Pediatric Alliance, PC Arcadia Division 9000 Perry Highway Suite 120
Pittsburgh, Pennsylvania, 15237, United States
5 Primary Physicians Research, Inc 1580 McLaughlin Run Road
Pittsburgh, Pennsylvania, 15241, United States
49 Pennridge Pediatric Associates 711 Lawn Avenue
Sellersville, Pennsylvania, 18960, United States
41 Palmetto Pediatrics, PA Pediatrics 2781 Tricom Street
Charleston, South Carolina, 29406, United States
71 Holston Medical Group 105 W. Stone Dr. Suite 2A
Kingsport, Tennessee, 37660, United States
72 Holston Medical Group 2033 Meadowview Lane
Kingsport, Tennessee, 37660, United States
165 Focus Research Group 201 Signature Place Suite C
Lebanon, Tennessee, 37087, United States
52 Heritage Medical Associates 2325 Crestmoor Road
Nashville, Tennessee, 37215, United States
90 Premier Medical Group Alpha Clinical Research 279 Clear Sky Court
Ste C Clarksville, Tennessee, 37043, United States
64 Amarillo Childrens Clinical Research #17 Care Circle
Amarillo, Texas, 79124, United States
19 University of North Texas Health Science Center 3500 Camp Bowie Blvd
Fort Worth, Texas, 76107, United States
175 Sealy Center for Vaccine Development, Clinical Trials 301 University Blvd. Children's Hospital Room 3.270F L#20412
Galveston, Texas, 77555-0351, United States
96 West Houston Clinical Research Service 2026 Wirt Road
Houston, Texas, 77055, United States
50 San Antonio Metropolitan Health District 332 West Commerce Room 307
San Antonio, Texas, 78205, United States
31 Southwest Children's Research Associates, P. A. 5282 Medical Drive Suite 311
San Antonio, Texas, 78229, United States
47 Dynamed Clinical Research 13406 Medical Complex Dr Suite 200
Tomball, Texas, 77375, United States
75 Pediatric Care 1596 S. 500 W., 1st Floor
Bountiful, Utah, 84010, United States
82 Dixie Pediatrics 1240 E 100 S STE 14 St.
George, Utah, 84790, United States
115 Wee Care(Layton) 1580 West Antelope Drive
Layton, Utah, 84041, United States
116 Wee Care(Kaysville) 934 South Main Street, Suite 8
Layton, Utah, 84041, United States
181 Jean Brown Research 164 East 5900 South Suite A-112
Murray, Utah, 84107, United States
74 Utah Valley Pediatrics North University 7407 North Cedar St.
Provo, Utah, 84604, United States
117 Wee Care(Roy) 5991 South 3500 West, Suite 100
Roy, Utah, 84067, United States
66 J. Lewis Research Inc. 2295 Foothill Drive
Salt Lake City, Utah, 84109, United States
61 Foothill Family Clinic South 6360 South 300 East Suite 100
Salt Lake City, Utah, 84121, United States
151 Family First Pediatrics c/o Pharmaceutical Research Organization 1268 W. South Jordan Parkway Suite 201
South Jordan, Utah, 84095, United States
44 Wee Care Pediatrics (Syracuse) 1792 West 1700 South Suite 102
Syracuse, Utah, 84075, United States
Jordan Ridge Kids & Teens 8822 S. Redwood Road Suite S103
West Jordan, Utah, 84088, United States
85 Pediatric Research of Charlottesville, LLC 1011 East Jefferson St. Suite 3
Charlottesville, Virginia, 22902, United States
158 Huguenot Pediatrics, PC 1407 Huguenot Rd.
Midlothian, Virginia, 23113, United States
46 Virginia Commonwealth University 1001 East Marshall Street P008
Richmond, Virginia, 23219, United States
93 Advanced Pediatrics 100 East Street SE Suite 301
Vienna, Virginia, 22180, United States
2 Rockwood Clinical Research Center 400 East Fifth Avenue
Spokane, Washington, 99202, United States
38 Rockwood Clinic, P.S. 9001 N. Country Homes Blvd.
Spokane, Washington, 99218, United States
124 The Vancouver Clinic/NE 87th Avenue 700 NE 87th Avenue
Vancouver, Washington, 98664, United States
125 The Vancouver Clinic/Columbia Tech Center 501 SE 172th Avenue
Vancouver, Washington, 98684, United States
167 The Vancouver Clinic/Salmon Creek 2525 NE 139th Street
Vancouver, Washington, 98686, United States
163 Wenatchee Valley Medical Center Clinical Research Department 820 North Chelan Avenue
Wenatchee, Washington, 98801, United States
304 Department of Pediatrics, Chang Gung Children's Hospital 12F, L Building, #5, Fu-Shin St.
Kweishan, Taoyuan 333, Taiwan, China
301 Department of Pediatrics, National Taiwan University Hospital, 15F,Children's Hospital, No. 8 Chung Shan S. Rd,
Taipei, Taiwan, 100, China
302 Department of Pediatrics, Mackay Memorial Hospital No. 92, Sec. 2, ChangShan Road,
Taipei, Taiwan, 104, China
303 Department of Pediatrics, Taiwan Adventist Hospital 424, Sec 2, Pa-Te Road,
Taipei, Taiwan, China
401 Clínica Pediátrica Calle 20 Ave 0 y 2 Costado Oeste del Hospital Nacional de Niños - segundo piso,
San José, Costa Rica, Costa Rica
402 Centro Integral Medico 25 m Oeste e la Junta de Protección Social,
San José, Costa Rica, Costa Rica
404 Instituto de Atención Pediátrica (IAP) Del Restaurante La Bastilla, 50m Sur, Paseo Colón
San José, Costa Rica, Costa Rica
403 Centro Médico San Vicente 125m Este de la entrada Principal de Emergencia del Hospital
San Vicente de Paul, Heredia, Costa Rica, Costa Rica
501 Hospital Infantil de Infectología y Rehabilitación 9ª. Avenida 7-01 Zona 11 Colonia Roosevelt,
Guatemala City, Departamento de Guatemala, CP 01011, Guatemala
507 Clínica Médica Privada Edificio Multimédica, 2 calle 25-19 Zona 15
Vista Hermosa I, Guatemala CP 01015, Guatemala
508 Unidad de Crecimiento y Desarrollo, Clínica del Niño Sano, Hospital Roosevelt 6ª Avenida 3-10 Zona 11, Ingreso Principal Hospital Roosevelt
Guatemala City, Guatemala CP. 01011, Guatemala
502 Clínica Privada 6a Avenida 3-22 Zona 10, Centro Médico II, Ofic. 601
Guatemala City, Guatemala Cp01010, Guatemala
503 Clínica para Niños 6a Avenida 6-63 Zona 10, Edificio Sixtino, Oficina 305, Tercer Nivel,
Guatemala City, Guatemala Cp01010, Guatemala
506 Health Center 4ª Avenida 16-72 Zona 10,
Guatemala City, Guatemala Cp01010, Guatemala
504 Clínica Periférica El Amparo II, 38 Calle 31-89, Zona 7 Colonia El Amparo II,
Guatemala City, Guatemala. CP 01007, Guatemala
601 Hospital Materno Infantil José Domingo De Obaldía, Centro para la Investigación y Desarrollo de Estudios Clínicos Vía Panamericana, San Pablo viejo, David,
Chiriquí, Panama
602 Centro Pediátrico América, Consultorio América Segundo Piso Consultorio No. 223, Vía España, Carrasquilla, Frente al Hospital de Especialidades Pediátricas
Panama City, Panama
603 Policentro Luis H. Moreno, Parque Lefevre
Via Cincuentenario, Panama
704 Hospital Nacional Docente Madre Niño San Bartolomé Av. Alfonso Ugarte 825,
Lima Cercado, Lima 01, Peru
701 Instituto de Investigación Nutricional - Anexo Huáscar, SJL Manzana 122, Lote 21, Grupo 15
Huascar, San Juan de Lurigancho, Lima 36, Peru
703 Hospital María Auxiliadora Av. Miguel Iglesias 968, San Juan de Miraflores,
Lima, Peru
705 Hospital Nacional Cayetano Heredia Av. Honorio Delgado No. 262, Urbanización Ingeniería, San Martín de Porres
Lima, Peru
708 Hospital Nacional Guillermo Almenara Irigoyen Av. Grau No. 800, La Victoria, Lima 13
Lima, Peru
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Posting Director
- Organization
- Novartis Vaccines and Diagnostics
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 9, 2008
First Posted
December 10, 2008
Study Start
December 1, 2008
Primary Completion
March 1, 2011
Study Completion
November 1, 2011
Last Updated
July 9, 2013
Results First Posted
July 9, 2013
Record last verified: 2013-05