Clinical trial NCT00806195: Study to Evaluate the Safety of Novartis MenACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Meningitis
Meningococcal Infection
Keywords: vaccine
infants
healthy
meningitis
meningococcal
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Novartis Vaccines
First posted: 2008-12-10
Enrollment: 7744
Sex: ALL
Minimum age (years): 55
Maximum age (years): 89
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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):

  1. receipt of any immunosuppressive therapy at any time since birth
  2. receipt of immunostimulants at any time since birth
  3. 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;
* who have any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives;
* who have received any investigational agents or vaccines since birth or who expect to receive an investigational agent or vaccine prior to the completion of the study.
* who are relatives of site research staff working on this study.

Primary outcomes:
measure: Percentages of Subjects With At Least One Severe Systemic Reaction After Any Vaccination
timeFrame: 15 minutes to Day 7 after any vaccination administered at 2, 4, 6 and 12 months of age
Secondary outcomes:
measure: Percentages of Subjects With At Least One Serious Adverse Event During the Entire Study Period
timeFrame: Day 1 (2 months of age) to 18 months of age
measure: Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination
timeFrame: 15 minutes to Day 7
measure: Number of Subjects Who Reported Unsolicited Adverse Events After Any Vaccination
timeFrame: Day 1 (2 months of age) to 18 months of age
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: 6 Alabama Clinical Therapeutics 806 St. Vincent's Drive, Ste 615
state: Alabama
city: Dothan
country: United States
facility: 43 Alabama Clinical Therapeutics, LLC 364 Honeysuckle Rd
state: Alabama
city: Tuscon
country: United States
facility: 81 Cholla Pediatrics 2167 West Orange Grove Road
state: Arizona
city: Benton
country: United States
facility: 55 Central Arkansas Pediatric Clinic Pediatric 2301 Springhill Road Suite 200
state: Arkansas
city: Fayetteville
country: United States
facility: 21 Northwest Arkansas Pediatric Clinic 3383 N. MANA Court Suite 101
state: Arkansas
city: Fort Smith
country: United States
facility: 30 Sparks Pediatric Clinic 1501 S. Waldron Road Suite 100
state: Arkansas
city: Jonesboro
country: United States
facility: 14 The Children's Clinic of Jonesboro 800 S. Church Suite 400
state: Arkansas
city: Little Rock
country: United States
facility: 170 Little Rock Children's Clinic P.A. 9600 Lile Dr., Ste 360
state: Arkansas
city: Little Rock
country: United States
facility: 3 Arkansas Pediatric Clinic 500 S. University Suite 200
state: Arkansas
city: Buena Park
country: United States
facility: 179 Associated Pharmaceutical Research Center, Inc 8615 Knott Avenue Suite 5
state: California
city: Canoga Park
country: United States
facility: 160 San Fernando Valley Research Associates, Inc. 7111 Winnetka Ave. #14
state: California
city: Dinuba
country: United States
facility: 157 Universal Biopharma Research Institute Inc./Alta Family Health Clinic 888 N. Alta Ave.
state: California
city: Downey
country: United States
facility: 1 Premier Health Research Center, LLC 11525 Brookshire Ave Suite 400
state: California
city: Fresno
country: United States
facility: 68 Sierra Medical Research 5150 N. Sixth, Suite 156
state: California
city: La Puente
country: United States
facility: 129 Citrus Vally Family Practice 1400 Hacienda Blvd
state: California
city: Loma Linda
country: United States
facility: 114 Loma Linda University Health 11175 Campus Street Coleman Pavillion A-1120
state: California
city: Loma Linda
country: United States
facility: 59 Loma Linda University Health 11175 Campus Street Coleman Pavillion A-1120
state: California
city: Long Beach
country: United States
facility: 153 Health Care Partners Medical Group Health Care Partners Medical Group 4401 Atlantic Ave.
state: California
city: Los Angeles
country: United States
facility: 94 Health Care Partners Medical Group 1025 W. Olympic Blvd.
state: California
city: Madera
country: United States
facility: 67 Madera Family Medical Group 1111 West 4th Street
state: California
city: Oakland
country: United States
facility: 121 Kaiser Permanente (Oakland) 3505 Broadway 6th floor
state: California
city: Oakland
country: United States
facility: 63 Kaiser Permanente Vaccine Study Center One Kaiser Plaza 16th Floor
state: California
city: Orange
country: United States
facility: 42 Children's Hospital of Orange County 455 S. Main Street
state: California
city: Paramount
country: United States
facility: 12 Center For Clinical Trials, LLC. 16660 Paramount Blvd Suite 301
state: California
city: Pleasanton
country: United States
facility: 122 Kaiser Permanente (Pleasanton) 7601 Stoneridge Drive, MOB North 2nd Floor
state: California
city: Sacramento
country: United States
facility: 57 UC Davis Medical Center 2516 Stockton Blvd Ticon II
state: California
city: San Francisco
country: United States
facility: 123 Kaiser Permanente (San Francisco) 2200 O'Farrell Street 6th floor room 636
state: California
city: San Jose
country: United States
facility: 166 Buena Salud Pediatrics 2880 Story Road
state: California
city: Torrance
country: United States
facility: 20 White Memorial Pediatric Medical Group UCLA Center for Vaccine Research 1124 West Carson Street Liu Research Building (Room 132)
state: California
city: Torrance
country: United States
facility: 152 Health Care Partners Medical Group 3565 Del Amo Blvd Research Dept.
state: California
city: West Covina
country: United States
facility: 40 Center for Clinical Trials of San Gabriel 1300 S Sunset Avenue Suite 101
state: California
city: Thornton
country: United States
facility: 54 1st International Research Centers 10370 Steeke Street
state: Colorado
city: Norwich
country: United States
facility: 29 Norwich Pediatric Group 92 New London Turnpike
state: Connecticut
city: Lake Mary
country: United States
facility: 99 Altamonte Pediatric Associates 101 N Country Club Rd.
state: Florida
city: Orlando
country: United States
facility: 60 Orlando Health Pediatric Faculty Practice 32 West Sturtevant St, MP-141
state: Florida
city: Palm Beach Gardens
country: United States
facility: 34 Pediatric Partners Pediatrics 3401 PGA Blvd Ste 300
state: Florida
city: Sarasota
country: United States
facility: 88 Physician Care Clinical Research 1918 Robinhood Street
state: Florida
city: Dalton
country: United States
facility: 162 North Georgia Clinical Research Center 1575 Chattanooga Avenue Suite 1
state: Georgia
city: Marietta
country: United States
facility: 11 Pediatrics and Adolescent Medicine, PA 2155 Post Oak Tritt Road Suite 100
state: Georgia
city: Woodstock
country: United States
facility: 101 Pediatrics and Adolescent Medicine, PA 120 Stonebridge Parkway, Suite 410
state: Georgia
city: Honolulu
country: United States
facility: 132 Kaiser Permanente Pediatric - Mapunapuna 2828 Paa Street, 2nd Floor
state: Hawaii
city: Waipahu
country: United States
facility: 131 Kaiser Permanente Waipio 1st Floor 94-1480 Moaniani Street
state: Hawaii
city: Dekalb
country: United States
facility: Northern Illinois Research Associates 625 E. Bethany Ste. 3
state: Illinois
city: Arkansas City
country: United States
facility: 95 Heartland Research Associates 510 West Radio Lane
state: Kansas
city: Newton
country: United States
facility: 92 Heartland Research Associates LLC 700 Medical Center Dr. Suite 210
state: Kansas
city: Topeka
country: United States
facility: 178 Pediatric Care 6725 Southwest Twenty-Ninth Street
state: Kansas
city: Bardstown
country: United States
facility: 51 Kentucky Pediatric/Adult Research 201 S. 5th Street
state: Kentucky
city: Lexington
country: United States
facility: 84 Michael W. Simon M.D. 185 Pasadena Drive Suite 220
state: Kentucky
city: Louisville
country: United States
facility: 106 University Child Health Specialists 230 East Broadway
state: Kentucky
city: Louisville
country: United States
facility: 24 Bluegrass Clinical Research, Inc 5512 Bardstown Road Suite 2
state: Kentucky
city: Louisville
country: United States
facility: 76 Bluegrass Clinical Research, Inc 5512 Bardstown Road Suite2
state: Kentucky
city: Ouisville
country: United States
facility: 15 University of Louisville 571 South Floyd Suite 321 L
state: Kentucky
city: Springfield
country: United States
facility: 108 Physicians to Children and Adolescents 102 West Depot Street
state: Kentucky
city: Shreveport
country: United States
facility: 86 Willis-Knighton Physician Network 7847 Youree Drive
state: Louisiana
city: Boston
country: United States
facility: 22 Roslindale Pediatric Assoc, P.C 1153 Centre St Suite 31
state: Massachusetts
city: Fall River
country: United States
facility: 23 Pediatric Associates of Fall River 829 South Main Street
state: Massachusetts
city: North Andover
country: United States
facility: 126 North Andover Pediatrics Associates 800 Turnpike Street
state: Massachusetts
city: Woburn
country: United States
facility: 9 Woburn Pediatric Associates 7 Alfred Street Baldwin Park II
state: Massachusetts
city: Niles
country: United States
facility: 168 Southwestern Medical Clinic 2002 South 11th Street
state: Michigan
city: Stevensville
country: United States
facility: 26 Southwestern Medical Clinic 5515 Cleveland Avenue Suite 1
state: Michigan
city: St. Paul
country: United States
facility: 89 Aspen Medical Group 1020 Bandana Blvd West Ste 214
state: Minnesota
city: Bridgeton
country: United States
facility: 80 Craig A. Spiegel, M.D 12255 DePaul Drive Sutie 380
state: Missouri
city: Las Vegas
country: United States
facility: 69 Clinical Research Center of Nevada 1012 East Sahara Avenue
state: Nevada
city: Brooklyn
country: United States
facility: 173 Maimonides Medical Center 948 48th Street 1st Floor
state: New York
city: Liverpool
country: United States
facility: 70 Summer Pediatrics 4811 Buckley Road
state: New York
city: Mineola
country: United States
facility: 16 Winthrop University Hospital Department of Pediatrics 120 Mineola Blvd Suite 210
state: New York
city: Syracuse
country: United States
facility: 77 SUNY Upstate Medical University 750 East Adams Street Suite 5400
state: New York
city: Cary
country: United States
facility: 56 Cary Pediatrics 1001 Crescent Green Dr.
state: North Carolina
city: Durham
country: United States
facility: 103 Durham Pediatrics 2609 North Duke Street, Suite 1000
state: North Carolina
city: Durham
country: United States
facility: 104 Regional Pediatrics 4022 Freedom Lake Drive
state: North Carolina
city: Durham
country: United States
facility: 13 Duke Health Center 4020 N. Roxboro Road
state: North Carolina
city: Raleigh
country: United States
facility: 48 Capitol Pediatrics and Adolescent Center 3801 Computer Drive Suite 200
state: North Carolina
city: Raleigh
country: United States
facility: 91 Triangle Medical Research 5816 Creedmoor Rd. Suite 104
state: North Carolina
city: Winston-Salem
country: United States
facility: 73 Piedmont Medical Research Assoc 1901 S Hawthorne Rd Ste 306
state: North Carolina
city: Fargo
country: United States
facility: 87 Innovis Health 1702 South University Drive Suite 1
state: North Dakota
city: Akron
country: United States
facility: 97 Children's Hospital Medical Center of Akron One Perkins Square
state: Ohio
city: Barberton
country: United States
facility: 120 Akron Children's Hospital Pediatrics 62 Conservatory Drive, #A
state: Ohio
city: Cleveland
country: United States
facility: 36 Dr. Senders and Associates, Pediatrics 2054 South Green Road
state: Ohio
city: Dayton
country: United States
facility: 79 Dayton Clinical Research 1100 Salem Ave
state: Ohio
city: Fairfield
country: United States
facility: 37 Pediatric Associates of Fairfield, Inc. 5900 Boymel Drive
state: Ohio
city: Huber Heights
country: United States
facility: 4 Ohio Pediatrics, INC 7371 Brandt Pike Suite C
state: Ohio
city: Kettering
country: United States
facility: 102 Ohio Pediatrics, INC 1775 Delco Park Drive
state: Ohio
city: Youngstown
country: United States
facility: 28 Pediatric Associates of Youngstown 4308 Belmont Avenue
state: Ohio
city: Youngstown
country: United States
facility: 100 Pediatric Associates of Youngstown 727 East Western Reserve Road
state: Ohio
city: Tulsa
country: United States
facility: 25 Oklahoma State University-CHS C/O Pediatrics 635 West 11th Street
state: Oklahoma
city: Beaverton
country: United States
facility: 83 The Portland Clinic LLP 15950 SW Millikan Lane Research Dept.
state: Oregon
city: Gresham
country: United States
facility: 7 Cyn3rgy Research 24850 SE Stark Street Suite 180
state: Oregon
city: Erie
country: United States
facility: 113 Children's Health Care-West 4671 West Lake Road
state: Pennsylvania
city: Greenville
country: United States
facility: 109 UPMC/Community Medicine Inc. 90 Shenango Street
state: Pennsylvania
city: Harleysville,
country: United States
facility: 107 Pennridge Pediatric Associates 270 Main Street
state: Pennsylvania
city: Pittsburgh
country: United States
facility: 110 Pediatric Alliance Southwestern - Squirrel Hill 4070 Beechwood Blvd
state: Pennsylvania
city: Pittsburgh
country: United States
facility: 112 Pediatric Alliance, Southwestern 850 Clairton Blvd
state: Pennsylvania
city: Pittsburgh
country: United States
facility: 118 Pediatric Alliance, PC Arcadia Division 9000 Perry Highway Suite 120
state: Pennsylvania
city: Pittsburgh
country: United States
facility: 5 Primary Physicians Research, Inc 1580 McLaughlin Run Road
state: Pennsylvania
city: Sellersville
country: United States
facility: 49 Pennridge Pediatric Associates 711 Lawn Avenue
state: Pennsylvania
city: Charleston
country: United States
facility: 41 Palmetto Pediatrics, PA Pediatrics 2781 Tricom Street
state: South Carolina
city: Kingsport
country: United States
facility: 71 Holston Medical Group 105 W. Stone Dr. Suite 2A
state: Tennessee
city: Kingsport
country: United States
facility: 72 Holston Medical Group 2033 Meadowview Lane
state: Tennessee
city: Lebanon
country: United States
facility: 165 Focus Research Group 201 Signature Place Suite C
state: Tennessee
city: Nashville
country: United States
facility: 52 Heritage Medical Associates 2325 Crestmoor Road
state: Tennessee
city: Ste C Clarksville
country: United States
facility: 90 Premier Medical Group Alpha Clinical Research 279 Clear Sky Court
state: Tennessee
city: Amarillo
country: United States
facility: 64 Amarillo Childrens Clinical Research #17 Care Circle
state: Texas
city: Fort Worth
country: United States
facility: 19 University of North Texas Health Science Center 3500 Camp Bowie Blvd
state: Texas
city: Galveston
country: United States
facility: 175 Sealy Center for Vaccine Development, Clinical Trials 301 University Blvd. Children's Hospital Room 3.270F L#20412
state: Texas
city: Houston
country: United States
facility: 96 West Houston Clinical Research Service 2026 Wirt Road
state: Texas
city: San Antonio
country: United States
facility: 50 San Antonio Metropolitan Health District 332 West Commerce Room 307
state: Texas
city: San Antonio
country: United States
facility: 31 Southwest Children's Research Associates, P. A. 5282 Medical Drive Suite 311
state: Texas
city: Tomball
country: United States
facility: 47 Dynamed Clinical Research 13406 Medical Complex Dr Suite 200
state: Texas
city: Bountiful
country: United States
facility: 75 Pediatric Care 1596 S. 500 W., 1st Floor
state: Utah
city: George
country: United States
facility: 82 Dixie Pediatrics 1240 E 100 S STE 14 St.
state: Utah
city: Layton
country: United States
facility: 115 Wee Care(Layton) 1580 West Antelope Drive
state: Utah
city: Layton
country: United States
facility: 116 Wee Care(Kaysville) 934 South Main Street, Suite 8
state: Utah
city: Murray
country: United States
facility: 181 Jean Brown Research 164 East 5900 South Suite A-112
state: Utah
city: Provo
country: United States
facility: 74 Utah Valley Pediatrics North University 7407 North Cedar St.
state: Utah
city: Roy
country: United States
facility: 117 Wee Care(Roy) 5991 South 3500 West, Suite 100
state: Utah
city: Salt Lake City
country: United States
facility: 66 J. Lewis Research Inc. 2295 Foothill Drive
state: Utah
city: Salt Lake City
country: United States
facility: 61 Foothill Family Clinic South 6360 South 300 East Suite 100
state: Utah
city: South Jordan
country: United States
facility: 151 Family First Pediatrics c/o Pharmaceutical Research Organization 1268 W. South Jordan Parkway Suite 201
state: Utah
city: Syracuse
country: United States
facility: 44 Wee Care Pediatrics (Syracuse) 1792 West 1700 South Suite 102
state: Utah
city: West Jordan
country: United States
facility: Jordan Ridge Kids & Teens 8822 S. Redwood Road Suite S103
state: Utah
city: Charlottesville
country: United States
facility: 85 Pediatric Research of Charlottesville, LLC 1011 East Jefferson St. Suite 3
state: Virginia
city: Midlothian
country: United States
facility: 158 Huguenot Pediatrics, PC 1407 Huguenot Rd.
state: Virginia
city: Richmond
country: United States
facility: 46 Virginia Commonwealth University 1001 East Marshall Street P008
state: Virginia
city: Vienna
country: United States
facility: 93 Advanced Pediatrics 100 East Street SE Suite 301
state: Virginia
city: Spokane
country: United States
facility: 2 Rockwood Clinical Research Center 400 East Fifth Avenue
state: Washington
city: Spokane
country: United States
facility: 38 Rockwood Clinic, P.S. 9001 N. Country Homes Blvd.
state: Washington
city: Vancouver
country: United States
facility: 124 The Vancouver Clinic/NE 87th Avenue 700 NE 87th Avenue
state: Washington
city: Vancouver
country: United States
facility: 125 The Vancouver Clinic/Columbia Tech Center 501 SE 172th Avenue
state: Washington
city: Vancouver
country: United States
facility: 167 The Vancouver Clinic/Salmon Creek 2525 NE 139th Street
state: Washington
city: Wenatchee
country: United States
facility: 163 Wenatchee Valley Medical Center Clinical Research Department 820 North Chelan Avenue
state: Washington
city: Kweishan, Taoyuan 333
country: China
facility: 304 Department of Pediatrics, Chang Gung Children's Hospital 12F, L Building, #5, Fu-Shin St.
state: Taiwan
city: Taipei
country: China
facility: 301 Department of Pediatrics, National Taiwan University Hospital, 15F,Children's Hospital, No. 8 Chung Shan S. Rd,
state: Taiwan
city: Taipei
country: China
facility: 302 Department of Pediatrics, Mackay Memorial Hospital No. 92, Sec. 2, ChangShan Road,
state: Taiwan
city: Taipei
country: China
facility: 303 Department of Pediatrics, Taiwan Adventist Hospital 424, Sec 2, Pa-Te Road,
state: Taiwan
city: San José
country: Costa Rica
facility: 401 Clínica Pediátrica Calle 20 Ave 0 y 2 Costado Oeste del Hospital Nacional de Niños - segundo piso,
city: San José
country: Costa Rica
facility: 402 Centro Integral Medico 25 m Oeste e la Junta de Protección Social,
city: San José
country: Costa Rica
facility: 404 Instituto de Atención Pediátrica (IAP) Del Restaurante La Bastilla, 50m Sur, Paseo Colón
city: San Vicente de Paul, Heredia
country: Costa Rica
facility: 403 Centro Médico San Vicente 125m Este de la entrada Principal de Emergencia del Hospital
city: Vista Hermosa I
country: Guatemala
facility: 507 Clínica Médica Privada Edificio Multimédica, 2 calle 25-19 Zona 15
state: Guatemala CP 01015
city: Guatemala City
country: Guatemala
facility: 508 Unidad de Crecimiento y Desarrollo, Clínica del Niño Sano, Hospital Roosevelt 6ª Avenida 3-10 Zona 11, Ingreso Principal Hospital Roosevelt
state: Guatemala CP. 01011
city: Guatemala City,
country: Guatemala
facility: 502 Clínica Privada 6a Avenida 3-22 Zona 10, Centro Médico II, Ofic. 601
state: Guatemala CP01010
city: Guatemala City
country: Guatemala
facility: 503 Clínica para Niños 6a Avenida 6-63 Zona 10, Edificio Sixtino, Oficina 305, Tercer Nivel,
state: Guatemala CP01010
city: Guatemala City
country: Guatemala
facility: 506 Health Center 4ª Avenida 16-72 Zona 10,
state: Guatemala CP01010
city: Guatemala City
country: Guatemala
facility: 504 Clínica Periférica El Amparo II, 38 Calle 31-89, Zona 7 Colonia El Amparo II,
state: Guatemala. CP 01007
city: Guatemala City,
country: Guatemala
facility: 501 Hospital Infantil de Infectología y Rehabilitación 9ª. Avenida 7-01 Zona 11 Colonia Roosevelt,
city: Chiriquí
country: Panama
facility: 601 Hospital Materno Infantil José Domingo De Obaldía, Centro para la Investigación y Desarrollo de Estudios Clínicos Vía Panamericana, San Pablo viejo, David,
city: Ciudad de Panamá
country: Panama
facility: 602 Centro Pediátrico América, Consultorio América Segundo Piso Consultorio No. 223, Vía España, Carrasquilla, Frente al Hospital de Especialidades Pediátricas
city: Via Cincuentenario
country: Panama
facility: 603 Policentro Luis H. Moreno, Parque Lefevre
city: Cercado de Lima
country: Peru
facility: 704 Hospital Nacional Docente Madre Niño San Bartolomé Av. Alfonso Ugarte 825,
state: Lima 01
city: Huascar, San Juan de Lurigancho
country: Peru
facility: 701 Instituto de Investigación Nutricional - Anexo Huáscar, SJL Manzana 122, Lote 21, Grupo 15
state: Lima 36
city: Lima 29
country: Peru
facility: 703 Hospital María Auxiliadora Av. Miguel Iglesias 968, San Juan de Miraflores,
city: Lima 31
country: Peru
facility: 705 Hospital Nacional Cayetano Heredia Av. Honorio Delgado No. 262, Urbanización Ingeniería, San Martín de Porres
city: Lima
country: Peru
facility: 708 Hospital Nacional Guillermo Almenara Irigoyen Av. Grau No. 800, La Victoria, Lima 13
Study officials:
References: