Study to Evaluate the Safety of Novartis MenACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants

This study has been completed.
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00806195
First received: December 9, 2008
Last updated: May 13, 2013
Last verified: May 2013
  Purpose

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


Condition Intervention Phase
Meningitis
Meningococcal Infection
Biological: 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
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Percentages of Subjects With At Least One Severe Systemic Reaction After Any Vaccination [ Time Frame: 15 minutes to Day 7 after any vaccination administered at 2, 4, 6 and 12 months of age ] [ Designated as safety issue: Yes ]

    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.



Secondary Outcome Measures:
  • Percentages of Subjects With At Least One Serious Adverse Event During the Entire Study Period [ Time Frame: Day 1 (2 months of age) to 18 months of age ] [ Designated as safety issue: Yes ]
    To compare the percentages of subjects presenting at least one serious adverse event (SAE) through 6 months post-final dose in subjects who received MenACWY-CRM197 vaccine concomitantly with routine vaccinations to the percentages of subjects who received routine vaccinations alone.

  • Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination [ Time Frame: 15 minutes to Day 7 ] [ Designated as safety issue: Yes ]
    To compare the percentage of subjects who reported local and systemic solicited adverse events from day 1 to day 7 after each vaccination with MenACWY-CRM197 given concomitantly with routine vaccinations to the routine vaccinations alone group.

  • Number of Subjects Who Reported Unsolicited Adverse Events After Any Vaccination [ Time Frame: Day 1 (2 months of age) to 18 months of age ] [ Designated as safety issue: Yes ]
    Safety data with medically attended events were collected throughout the study in the non-detailed safety groups and from Day 8 onwards for the detailed safety groups.


Enrollment: 7744
Study Start Date: December 2008
Study Completion Date: November 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MenACWY-CRM197 + Routine Vaccines (Non-Detailed)

Infants 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).

Biological: MenACWY-CRM197
Four 0.5mL vaccinations of MenACWY-CRM197 conjugate vaccine was administered by intramuscular injection at 2, 4, 6 and 12 months of age.
Biological: DTaP (Diptheria, Tetanus, Pertussis) Vaccine
Four vaccinations of DTaP (Diptheria, Tetanus, Pertussis) was administered at 2, 4, 6, and 15 months of age.
Biological: Hib (Haemophilus influenza b) Vaccine
Four vaccinations of Hib (Haemophilus influenza b) vaccine was administered at 2, 4, 6 and 15 months of age.
Biological: IPV (Inactivated Polio Vaccine) Vaccine
Three vaccinations of IPV (Inactivated Polio Vaccine) was administered at 2, 4, and 6 months of age.
Biological: Pneumococcal conjugate Vaccine
Four vaccinations of Pneumococcal conjugate vaccine was administered at 2, 4, 6 and 12 months of age.
Biological: MMR (Measles, Mumps, and Rubella) Vaccine
One vaccination of MMR (Measles, Mumps, and Rubella) was administered at 12 months of age.
Active Comparator: Routine Vaccines (Non-Detailed)

Infants 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.

Biological: DTaP (Diptheria, Tetanus, Pertussis) Vaccine
Four vaccinations of DTaP (Diptheria, Tetanus, Pertussis) was administered at 2, 4, 6, and 15 months of age.
Biological: Hib (Haemophilus influenza b) Vaccine
Four vaccinations of Hib (Haemophilus influenza b) vaccine was administered at 2, 4, 6 and 15 months of age.
Biological: IPV (Inactivated Polio Vaccine) Vaccine
Three vaccinations of IPV (Inactivated Polio Vaccine) was administered at 2, 4, and 6 months of age.
Biological: Pneumococcal conjugate Vaccine
Four vaccinations of Pneumococcal conjugate vaccine was administered at 2, 4, 6 and 12 months of age.
Biological: MMR (Measles, Mumps, and Rubella) Vaccine
One vaccination of MMR (Measles, Mumps, and Rubella) was administered at 12 months of age.
Experimental: MenACWY-CRM197 + Routine Vaccines (Detailed)

Infants 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.

Biological: MenACWY-CRM197
Four 0.5mL vaccinations of MenACWY-CRM197 conjugate vaccine was administered by intramuscular injection at 2, 4, 6 and 12 months of age.
Biological: DTaP (Diptheria, Tetanus, Pertussis) Vaccine
Four vaccinations of DTaP (Diptheria, Tetanus, Pertussis) was administered at 2, 4, 6, and 15 months of age.
Biological: Hib (Haemophilus influenza b) Vaccine
Four vaccinations of Hib (Haemophilus influenza b) vaccine was administered at 2, 4, 6 and 15 months of age.
Biological: IPV (Inactivated Polio Vaccine) Vaccine
Three vaccinations of IPV (Inactivated Polio Vaccine) was administered at 2, 4, and 6 months of age.
Biological: Pneumococcal conjugate Vaccine
Four vaccinations of Pneumococcal conjugate vaccine was administered at 2, 4, 6 and 12 months of age.
Biological: MMR (Measles, Mumps, and Rubella) Vaccine
One vaccination of MMR (Measles, Mumps, and Rubella) was administered at 12 months of age.
Biological: Varicella Vaccine
One vaccination of Varicella vaccine was administered at 12 months of age.
Biological: Hepatitis A Virus
One vaccination of Hepatitis A Virus vaccine was administered at 12 months of age.
Active Comparator: Routine Vaccines (Detailed)

Infants 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.

Biological: DTaP (Diptheria, Tetanus, Pertussis) Vaccine
Four vaccinations of DTaP (Diptheria, Tetanus, Pertussis) was administered at 2, 4, 6, and 15 months of age.
Biological: Hib (Haemophilus influenza b) Vaccine
Four vaccinations of Hib (Haemophilus influenza b) vaccine was administered at 2, 4, 6 and 15 months of age.
Biological: IPV (Inactivated Polio Vaccine) Vaccine
Three vaccinations of IPV (Inactivated Polio Vaccine) was administered at 2, 4, and 6 months of age.
Biological: Pneumococcal conjugate Vaccine
Four vaccinations of Pneumococcal conjugate vaccine was administered at 2, 4, 6 and 12 months of age.
Biological: MMR (Measles, Mumps, and Rubella) Vaccine
One vaccination of MMR (Measles, Mumps, and Rubella) was administered at 12 months of age.
Biological: Varicella Vaccine
One vaccination of Varicella vaccine was administered at 12 months of age.
Biological: Hepatitis A Virus
One vaccination of Hepatitis A Virus vaccine was administered at 12 months of age.
Experimental: MenACWY-CRM197 + Routine Vaccines (All)

Infants 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.

Biological: MenACWY-CRM197
Four 0.5mL vaccinations of MenACWY-CRM197 conjugate vaccine was administered by intramuscular injection at 2, 4, 6 and 12 months of age.
Biological: DTaP (Diptheria, Tetanus, Pertussis) Vaccine
Four vaccinations of DTaP (Diptheria, Tetanus, Pertussis) was administered at 2, 4, 6, and 15 months of age.
Biological: Hib (Haemophilus influenza b) Vaccine
Four vaccinations of Hib (Haemophilus influenza b) vaccine was administered at 2, 4, 6 and 15 months of age.
Biological: IPV (Inactivated Polio Vaccine) Vaccine
Three vaccinations of IPV (Inactivated Polio Vaccine) was administered at 2, 4, and 6 months of age.
Biological: Pneumococcal conjugate Vaccine
Four vaccinations of Pneumococcal conjugate vaccine was administered at 2, 4, 6 and 12 months of age.
Biological: MMR (Measles, Mumps, and Rubella) Vaccine
One vaccination of MMR (Measles, Mumps, and Rubella) was administered at 12 months of age.
Biological: Varicella Vaccine
One vaccination of Varicella vaccine was administered at 12 months of age.
Biological: Hepatitis A Virus
One vaccination of Hepatitis A Virus vaccine was administered at 12 months of age.
Active Comparator: Routine Vaccines (All)

Infants 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.

Biological: DTaP (Diptheria, Tetanus, Pertussis) Vaccine
Four vaccinations of DTaP (Diptheria, Tetanus, Pertussis) was administered at 2, 4, 6, and 15 months of age.
Biological: Hib (Haemophilus influenza b) Vaccine
Four vaccinations of Hib (Haemophilus influenza b) vaccine was administered at 2, 4, 6 and 15 months of age.
Biological: IPV (Inactivated Polio Vaccine) Vaccine
Three vaccinations of IPV (Inactivated Polio Vaccine) was administered at 2, 4, and 6 months of age.
Biological: Pneumococcal conjugate Vaccine
Four vaccinations of Pneumococcal conjugate vaccine was administered at 2, 4, 6 and 12 months of age.
Biological: MMR (Measles, Mumps, and Rubella) Vaccine
One vaccination of MMR (Measles, Mumps, and Rubella) was administered at 12 months of age.
Biological: Varicella Vaccine
One vaccination of Varicella vaccine was administered at 12 months of age.
Biological: Hepatitis A Virus
One vaccination of Hepatitis A Virus vaccine was administered at 12 months of age.

  Eligibility

Ages Eligible for Study:   55 Days to 89 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00806195

  Hide Study Locations
Locations
United States, Alabama
6 Alabama Clinical Therapeutics 806 St. Vincent's Drive, Ste 615
Birmingham, Alabama, United States, 35205
43 Alabama Clinical Therapeutics, LLC 364 Honeysuckle Rd
Dothan, Alabama, United States, 36305
United States, Arizona
81 Cholla Pediatrics 2167 West Orange Grove Road
Tuscon, Arizona, United States, 85741
United States, Arkansas
55 Central Arkansas Pediatric Clinic Pediatric 2301 Springhill Road Suite 200
Benton, Arkansas, United States, 72019
21 Northwest Arkansas Pediatric Clinic 3383 N. MANA Court Suite 101
Fayetteville, Arkansas, United States, 72703
30 Sparks Pediatric Clinic 1501 S. Waldron Road Suite 100
Fort Smith, Arkansas, United States, 72903
14 The Children's Clinic of Jonesboro 800 S. Church Suite 400
Jonesboro, Arkansas, United States, 72401
3 Arkansas Pediatric Clinic 500 S. University Suite 200
Little Rock, Arkansas, United States, 72205
170 Little Rock Children's Clinic P.A. 9600 Lile Dr., Ste 360
Little Rock, Arkansas, United States, 72205
United States, California
179 Associated Pharmaceutical Research Center, Inc 8615 Knott Avenue Suite 5
Buena Park, California, United States, 90620
160 San Fernando Valley Research Associates, Inc. 7111 Winnetka Ave. #14
Canoga Park, California, United States, 91306
157 Universal Biopharma Research Institute Inc./Alta Family Health Clinic 888 N. Alta Ave.
Dinuba, California, United States, 93618
1 Premier Health Research Center, LLC 11525 Brookshire Ave Suite 400
Downey, California, United States, 90241-4982
68 Sierra Medical Research 5150 N. Sixth, Suite 156
Fresno, California, United States, 93710
129 Citrus Vally Family Practice 1400 Hacienda Blvd
La Puente, California, United States, 91744
59 Loma Linda University Health 11175 Campus Street Coleman Pavillion A-1120
Loma Linda, California, United States, 92354
114 Loma Linda University Health 11175 Campus Street Coleman Pavillion A-1120
Loma Linda, California, United States, 92354
153 Health Care Partners Medical Group Health Care Partners Medical Group 4401 Atlantic Ave.
Long Beach, California, United States, 90807
94 Health Care Partners Medical Group 1025 W. Olympic Blvd.
Los Angeles, California, United States, 90015
67 Madera Family Medical Group 1111 West 4th Street
Madera, California, United States, 93637
121 Kaiser Permanente (Oakland) 3505 Broadway 6th floor
Oakland, California, United States, 94611
63 Kaiser Permanente Vaccine Study Center One Kaiser Plaza 16th Floor
Oakland, California, United States, 94611
42 Children's Hospital of Orange County 455 S. Main Street
Orange, California, United States, 92868
12 Center For Clinical Trials, LLC. 16660 Paramount Blvd Suite 301
Paramount, California, United States, 90723
122 Kaiser Permanente (Pleasanton) 7601 Stoneridge Drive, MOB North 2nd Floor
Pleasanton, California, United States, 94588
57 UC Davis Medical Center 2516 Stockton Blvd Ticon II
Sacramento, California, United States, 95817
123 Kaiser Permanente (San Francisco) 2200 O'Farrell Street 6th floor room 636
San Francisco, California, United States, 94115
166 Buena Salud Pediatrics 2880 Story Road
San Jose, California, United States, 95127
152 Health Care Partners Medical Group 3565 Del Amo Blvd Research Dept.
Torrance, California, United States, 90503
20 White Memorial Pediatric Medical Group UCLA Center for Vaccine Research 1124 West Carson Street Liu Research Building (Room 132)
Torrance, California, United States, 90502
40 Center for Clinical Trials of San Gabriel 1300 S Sunset Avenue Suite 101
West Covina, California, United States, 91790
United States, Colorado
54 1st International Research Centers 10370 Steeke Street
Thornton, Colorado, United States, 80229
United States, Connecticut
29 Norwich Pediatric Group 92 New London Turnpike
Norwich, Connecticut, United States, 06360
United States, Florida
99 Altamonte Pediatric Associates 101 N Country Club Rd.
Lake Mary, Florida, United States, 32746
60 Orlando Health Pediatric Faculty Practice 32 West Sturtevant St, MP-141
Orlando, Florida, United States, 32806
34 Pediatric Partners Pediatrics 3401 PGA Blvd Ste 300
Palm Beach Gardens, Florida, United States, 33410
88 Physician Care Clinical Research 1918 Robinhood Street
Sarasota, Florida, United States, 34231
United States, Georgia
162 North Georgia Clinical Research Center 1575 Chattanooga Avenue Suite 1
Dalton, Georgia, United States, 30721
11 Pediatrics and Adolescent Medicine, PA 2155 Post Oak Tritt Road Suite 100
Marietta, Georgia, United States, 30062
101 Pediatrics and Adolescent Medicine, PA 120 Stonebridge Parkway, Suite 410
Woodstock, Georgia, United States, 30189
United States, Hawaii
132 Kaiser Permanente Pediatric - Mapunapuna 2828 Paa Street, 2nd Floor
Honolulu, Hawaii, United States, 96819
131 Kaiser Permanente Waipio 1st Floor 94-1480 Moaniani Street
Waipahu, Hawaii, United States, 96797
United States, Illinois
Northern Illinois Research Associates 625 E. Bethany Ste. 3
Dekalb, Illinois, United States, 60115
United States, Kansas
95 Heartland Research Associates 510 West Radio Lane
Arkansas City, Kansas, United States, 67005
92 Heartland Research Associates LLC 700 Medical Center Dr. Suite 210
Newton, Kansas, United States, 67114
178 Pediatric Care 6725 Southwest Twenty-Ninth Street
Topeka, Kansas, United States, 66614
United States, Kentucky
51 Kentucky Pediatric/Adult Research 201 S. 5th Street
Bardstown, Kentucky, United States, 40004
84 Michael W. Simon M.D. 185 Pasadena Drive Suite 220
Lexington, Kentucky, United States, 40503
24 Bluegrass Clinical Research, Inc 5512 Bardstown Road Suite 2
Louisville, Kentucky, United States, 40291
76 Bluegrass Clinical Research, Inc 5512 Bardstown Road Suite2
Louisville, Kentucky, United States, 40291
106 University Child Health Specialists 230 East Broadway
Louisville, Kentucky, United States, 40202
15 University of Louisville 571 South Floyd Suite 321 L
Ouisville, Kentucky, United States, 40202
108 Physicians to Children and Adolescents 102 West Depot Street
Springfield, Kentucky, United States, 40069
United States, Louisiana
86 Willis-Knighton Physician Network 7847 Youree Drive
Shreveport, Louisiana, United States, 71105
United States, Massachusetts
22 Roslindale Pediatric Assoc, P.C 1153 Centre St Suite 31
Boston, Massachusetts, United States, 02130
23 Pediatric Associates of Fall River 829 South Main Street
Fall River, Massachusetts, United States, 02724
126 North Andover Pediatrics Associates 800 Turnpike Street
North Andover, Massachusetts, United States, 01845
9 Woburn Pediatric Associates 7 Alfred Street Baldwin Park II
Woburn, Massachusetts, United States, 01801
United States, Michigan
168 Southwestern Medical Clinic 2002 South 11th Street
Niles, Michigan, United States, 49120
26 Southwestern Medical Clinic 5515 Cleveland Avenue Suite 1
Stevensville, Michigan, United States, 49127
United States, Minnesota
89 Aspen Medical Group 1020 Bandana Blvd West Ste 214
St. Paul, Minnesota, United States, 55108
United States, Missouri
80 Craig A. Spiegel, M.D 12255 DePaul Drive Sutie 380
Bridgeton, Missouri, United States, 63044
United States, Nevada
69 Clinical Research Center of Nevada 1012 East Sahara Avenue
Las Vegas, Nevada, United States, 89104
United States, New York
173 Maimonides Medical Center 948 48th Street 1st Floor
Brooklyn, New York, United States, 11219
70 Summer Pediatrics 4811 Buckley Road
Liverpool, New York, United States, 13088
16 Winthrop University Hospital Department of Pediatrics 120 Mineola Blvd Suite 210
Mineola, New York, United States, 11501
77 SUNY Upstate Medical University 750 East Adams Street Suite 5400
Syracuse, New York, United States, 13210
United States, North Carolina
56 Cary Pediatrics 1001 Crescent Green Dr.
Cary, North Carolina, United States, 27511
13 Duke Health Center 4020 N. Roxboro Road
Durham, North Carolina, United States, 27704
104 Regional Pediatrics 4022 Freedom Lake Drive
Durham, North Carolina, United States, 27704
103 Durham Pediatrics 2609 North Duke Street, Suite 1000
Durham, North Carolina, United States, 27704
91 Triangle Medical Research 5816 Creedmoor Rd. Suite 104
Raleigh, North Carolina, United States, 27612
48 Capitol Pediatrics and Adolescent Center 3801 Computer Drive Suite 200
Raleigh, North Carolina, United States, 27609
73 Piedmont Medical Research Assoc 1901 S Hawthorne Rd Ste 306
Winston-Salem, North Carolina, United States, 27103
United States, North Dakota
87 Innovis Health 1702 South University Drive Suite 1
Fargo, North Dakota, United States, 58103
United States, Ohio
97 Children's Hospital Medical Center of Akron One Perkins Square
Akron, Ohio, United States, 44308
120 Akron Children's Hospital Pediatrics 62 Conservatory Drive, #A
Barberton, Ohio, United States, 44203
36 Dr. Senders and Associates, Pediatrics 2054 South Green Road
Cleveland, Ohio, United States, 44121
79 Dayton Clinical Research 1100 Salem Ave
Dayton, Ohio, United States, 45406
37 Pediatric Associates of Fairfield, Inc. 5900 Boymel Drive
Fairfield, Ohio, United States, 45014
4 Ohio Pediatrics, INC 7371 Brandt Pike Suite C
Huber Heights, Ohio, United States, 45424-3200
102 Ohio Pediatrics, INC 1775 Delco Park Drive
Kettering, Ohio, United States, 45420
100 Pediatric Associates of Youngstown 727 East Western Reserve Road
Youngstown, Ohio, United States, 44514
28 Pediatric Associates of Youngstown 4308 Belmont Avenue
Youngstown, Ohio, United States, 44505
United States, Oklahoma
25 Oklahoma State University-CHS C/O Pediatrics 635 West 11th Street
Tulsa, Oklahoma, United States, 74127
United States, Oregon
83 The Portland Clinic LLP 15950 SW Millikan Lane Research Dept.
Beaverton, Oregon, United States, 97006
7 Cyn3rgy Research 24850 SE Stark Street Suite 180
Gresham, Oregon, United States, 97030
United States, Pennsylvania
113 Children's Health Care-West 4671 West Lake Road
Erie, Pennsylvania, United States, 16505
109 UPMC/Community Medicine Inc. 90 Shenango Street
Greenville, Pennsylvania, United States, 16125
107 Pennridge Pediatric Associates 270 Main Street
Harleysville,, Pennsylvania, United States, 19438
5 Primary Physicians Research, Inc 1580 McLaughlin Run Road
Pittsburgh, Pennsylvania, United States, 15241
110 Pediatric Alliance Southwestern - Squirrel Hill 4070 Beechwood Blvd
Pittsburgh, Pennsylvania, United States, 15217
112 Pediatric Alliance, Southwestern 850 Clairton Blvd
Pittsburgh, Pennsylvania, United States, 15236
118 Pediatric Alliance, PC Arcadia Division 9000 Perry Highway Suite 120
Pittsburgh, Pennsylvania, United States, 15237
49 Pennridge Pediatric Associates 711 Lawn Avenue
Sellersville, Pennsylvania, United States, 18960
United States, South Carolina
41 Palmetto Pediatrics, PA Pediatrics 2781 Tricom Street
Charleston, South Carolina, United States, 29406
United States, Tennessee
72 Holston Medical Group 2033 Meadowview Lane
Kingsport, Tennessee, United States, 37660
71 Holston Medical Group 105 W. Stone Dr. Suite 2A
Kingsport, Tennessee, United States, 37660
165 Focus Research Group 201 Signature Place Suite C
Lebanon, Tennessee, United States, 37087
52 Heritage Medical Associates 2325 Crestmoor Road
Nashville, Tennessee, United States, 37215
90 Premier Medical Group Alpha Clinical Research 279 Clear Sky Court
Ste C Clarksville, Tennessee, United States, 37043
United States, Texas
64 Amarillo Childrens Clinical Research #17 Care Circle
Amarillo, Texas, United States, 79124
19 University of North Texas Health Science Center 3500 Camp Bowie Blvd
Fort Worth, Texas, United States, 76107
175 Sealy Center for Vaccine Development, Clinical Trials 301 University Blvd. Children's Hospital Room 3.270F L#20412
Galveston, Texas, United States, 77555-0351
96 West Houston Clinical Research Service 2026 Wirt Road
Houston, Texas, United States, 77055
50 San Antonio Metropolitan Health District 332 West Commerce Room 307
San Antonio, Texas, United States, 78205
31 Southwest Children's Research Associates, P. A. 5282 Medical Drive Suite 311
San Antonio, Texas, United States, 78229
47 Dynamed Clinical Research 13406 Medical Complex Dr Suite 200
Tomball, Texas, United States, 77375
United States, Utah
75 Pediatric Care 1596 S. 500 W., 1st Floor
Bountiful, Utah, United States, 84010
82 Dixie Pediatrics 1240 E 100 S STE 14 St.
George, Utah, United States, 84790
115 Wee Care(Layton) 1580 West Antelope Drive
Layton, Utah, United States, 84041
116 Wee Care(Kaysville) 934 South Main Street, Suite 8
Layton, Utah, United States, 84041
181 Jean Brown Research 164 East 5900 South Suite A-112
Murray, Utah, United States, 84107
74 Utah Valley Pediatrics North University 7407 North Cedar St.
Provo, Utah, United States, 84604
117 Wee Care(Roy) 5991 South 3500 West, Suite 100
Roy, Utah, United States, 84067
66 J. Lewis Research Inc. 2295 Foothill Drive
Salt Lake City, Utah, United States, 84109
61 Foothill Family Clinic South 6360 South 300 East Suite 100
Salt Lake City, Utah, United States, 84121
151 Family First Pediatrics c/o Pharmaceutical Research Organization 1268 W. South Jordan Parkway Suite 201
South Jordan, Utah, United States, 84095
44 Wee Care Pediatrics (Syracuse) 1792 West 1700 South Suite 102
Syracuse, Utah, United States, 84075
Jordan Ridge Kids & Teens 8822 S. Redwood Road Suite S103
West Jordan, Utah, United States, 84088
United States, Virginia
85 Pediatric Research of Charlottesville, LLC 1011 East Jefferson St. Suite 3
Charlottesville, Virginia, United States, 22902
158 Huguenot Pediatrics, PC 1407 Huguenot Rd.
Midlothian, Virginia, United States, 23113
46 Virginia Commonwealth University 1001 East Marshall Street P008
Richmond, Virginia, United States, 23219
93 Advanced Pediatrics 100 East Street SE Suite 301
Vienna, Virginia, United States, 22180
United States, Washington
2 Rockwood Clinical Research Center 400 East Fifth Avenue
Spokane, Washington, United States, 99202
38 Rockwood Clinic, P.S. 9001 N. Country Homes Blvd.
Spokane, Washington, United States, 99218
124 The Vancouver Clinic/NE 87th Avenue 700 NE 87th Avenue
Vancouver, Washington, United States, 98664
125 The Vancouver Clinic/Columbia Tech Center 501 SE 172th Avenue
Vancouver, Washington, United States, 98684
167 The Vancouver Clinic/Salmon Creek 2525 NE 139th Street
Vancouver, Washington, United States, 98686
163 Wenatchee Valley Medical Center Clinical Research Department 820 North Chelan Avenue
Wenatchee, Washington, United States, 98801
China, Taiwan
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, China, 100
303 Department of Pediatrics, Taiwan Adventist Hospital 424, Sec 2, Pa-Te Road,
Taipei, Taiwan, China
302 Department of Pediatrics, Mackay Memorial Hospital No. 92, Sec. 2, ChangShan Road,
Taipei, Taiwan, China, 104
Costa Rica
401 Clínica Pediátrica Calle 20 Ave 0 y 2 Costado Oeste del Hospital Nacional de Niños - segundo piso,
San José, Costa Rica
402 Centro Integral Medico 25 m Oeste e la Junta de Protección Social,
San José, Costa Rica
404 Instituto de Atención Pediátrica (IAP) Del Restaurante La Bastilla, 50m Sur, Paseo Colón
San José, Costa Rica
403 Centro Médico San Vicente 125m Este de la entrada Principal de Emergencia del Hospital
San Vicente de Paul, Heredia, Costa Rica
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
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
502 Clínica Privada 6a Avenida 3-22 Zona 10, Centro Médico II, Ofic. 601
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
501 Hospital Infantil de Infectología y Rehabilitación 9ª. Avenida 7-01 Zona 11 Colonia Roosevelt,
Guatemala City,, Guatemala, CP 01011
Panama
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
Ciudad de Panamá, Panama
603 Policentro Luis H. Moreno, Parque Lefevre
Via Cincuentenario, Panama
Peru
704 Hospital Nacional Docente Madre Niño San Bartolomé Av. Alfonso Ugarte 825,
Cercado de Lima, 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
708 Hospital Nacional Guillermo Almenara Irigoyen Av. Grau No. 800, La Victoria, Lima 13
Lima, Peru
703 Hospital María Auxiliadora Av. Miguel Iglesias 968, San Juan de Miraflores,
Lima 29, Peru
705 Hospital Nacional Cayetano Heredia Av. Honorio Delgado No. 262, Urbanización Ingeniería, San Martín de Porres
Lima 31, Peru
Sponsors and Collaborators
Novartis
Novartis Vaccines
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00806195     History of Changes
Other Study ID Numbers: V59P23
Study First Received: December 9, 2008
Results First Received: May 13, 2013
Last Updated: May 13, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
vaccine
infants
healthy
meningitis
meningococcal

Additional relevant MeSH terms:
Meningitis
Meningococcal Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on September 18, 2014