A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Infants
February 24, 2014 updated by: Novartis Vaccines
A Phase 3, Open-Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Safety and Immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants
This study will evaluate the safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine when administered with routine infant vaccinations to healthy infants.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
4545
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Buenos Aires, Argentina, C1406DGI
- Buenos Aires, Argentina
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Cordoba, Argentina, X5000BJH
- CdePAP, Centro De Desarrollo De Proyectos Avanzados Roma 1465,
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Scalabrini Ortiz 676, Buenos Aires, Buenos Aires,, Argentina
- Centro Estudios Infect
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Cordoba
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Alvear 1439 PB Dpto, rio IV, Cordoba, Cordoba, Argentina
- CEDEPAP Rio IV
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Castro Barros 650 - Barrio San Martin, Cordoba, Cordoba, Argentina
- Hospitales Materno Neonatal,
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Mendoza n°2152, Villa Maria, Cordoba,, Cordoba, Argentina
- Hospital Regional Luis Pasteur,
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Cali
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Calle 1 #50-51, Cali, Colombia, 405
- Siloe
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Calle 6#5-42, Cali, Colombia, 405
- Comfenalco
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Calle 72U 28 F-00, Cali, Colombia, 405
- Hospital C H Trujillo
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Ped Calle 5B5 No.37 BIS-28, Cali, Colombia, 405
- Corporation Cientifica
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Alabama
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Bessemer, Alabama, United States, 35022
- Growing Up Pediatrics
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Birmingham, Alabama, United States, 03523
- Alabama Clinical Therapeutics, LLC
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Birmingham, Alabama, United States, 35242
- Growing Up Pediatrics
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California
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Downey, California, United States, 90241
- Premier Health Research Center, LLC
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Oakland, California, United States, 94611
- Kaiser Permanente Oakland
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Oakland, California, United States, 94612
- Kaiser Permanente Med Group - Vaccine Study Ctr
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Paramount, California, United States, 90723
- Center for Clinical Trials, LLC
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Pleasanton, California, United States, 94588
- Kaiser Permanente Pleasanton
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Richmond, California, United States, 94801
- Kaiser Permanente Richmond
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San Francisco, California, United States, 94115
- Kaiser Permanente San Francisco
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Santa Clara, California, United States, 95051
- Kaiser Permanente Santa Clara
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Torrence, California, United States, 90502
- UCLA Center for Vaccine Research
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Colorado
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Aurora, Colorado, United States, 80045
- The Children's Hospital
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Longmont, Colorado, United States, 80501
- Longmont Medical Research Network
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Illinois
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Chicago, Illinois, United States, 60614-3394
- Children's Memorial Hospital
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Kentucky
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Bardstown, Kentucky, United States, 40004
- Kentucky Pediatric/Adult Research Inc.
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Maryland
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Annapolis, Maryland, United States, 21401
- Annapolis Pediatrics
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Baltimore, Maryland, United States, 21201
- Center for Vaccine Development
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Frederick, Maryland, United States, 21702
- The Pediatric Center
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Massachusetts
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Boston, Massachusetts, United States, 02118
- Boston University Medical Center
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Fall River, Massachusetts, United States, 02724
- Pediatric Associates of Fall River
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Nebraska
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Omaha, Nebraska, United States, 68131
- Creighton University
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Omaha, Nebraska, United States, 68132
- Children's Physicians Dundee
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New Hampshire
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Lebanon, New Hampshire, United States, 03756
- Dartmouth Hitchcock Medical Center
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New York
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Bronx, New York, United States, 10461
- Montefiore Medical Center
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Ohio
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Akron, Ohio, United States, 44308
- Akron Children's Hospital
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Boardman, Ohio, United States, 44512
- Louis P. Brine, Jr., MD, Beeghley Medical Park
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Cleveland, Ohio, United States, 44118
- Senders Pediatric Research at Dr. Senders and Associates
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Pennsylvania
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Carnegie, Pennsylvania, United States, 15106
- Carnegie Pediatrics
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Erie, Pennsylvania, United States, 16505
- Children's Health Care - West
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Greenville, Pennsylvania, United States, 16125
- UPMC/Community Medicine, Inc.
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Grove City, Pennsylvania, United States, 16127
- Family Healthcare Partners
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Harleyville, Pennsylvania, United States, 19438
- Pennridge Pediatric Associates
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Latrobe, Pennsylvania, United States, 15650
- Pediatric Associates of Latrobe
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Norristown, Pennsylvania, United States, 19401
- Pediatric Medical Associates
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Pittsburgh, Pennsylvania, United States, 15241
- Primary Physicians Research, Inc
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Pittsburgh, Pennsylvania, United States, 15217
- Squirrel Hill Office
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Pittsburgh, Pennsylvania, United States, 15220
- Pediatric Alliance, Greentree Division
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Pittsburgh, Pennsylvania, United States, 15227
- South Hills Pediatrics
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Pittsburgh, Pennsylvania, United States, 15236
- Pediatric Alliance, Southwestern
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Rydal, Pennsylvania, United States, 19046
- Pediatrics Medical Associates
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Sellersville, Pennsylvania, United States, 18960
- Pennridge Pediatric Associates
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Uniontown, Pennsylvania, United States, 15401
- Laurel Pediatrics
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Wexford, Pennsylvania, United States, 15090
- CCP - Pittsburgh Pediatrics
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Tennessee
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Madison, Tennessee, United States, 37115-2154
- Goodlettsville Pediatrics
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Texas
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Dallas, Texas, United States, 75234
- Research Across America
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Houston, Texas, United States, 77024
- Mercury Pharma Services
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Temple, Texas, United States, 76508
- Scott and White Hospital
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Utah
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Layton, Utah, United States, 84041
- Wee Care Pediatrics
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Orem, Utah, United States, 84057
- Utah Valley Pediatrics - Timpanogos
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Salt Lake City, Utah, United States, 84121
- Foothill Family Clinic
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South Jordan, Utah, United States, 84095
- CopperView Medical Center
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Wisconsin
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Monroe, Wisconsin, United States, 53566
- Monroe Medical Foundation
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 months to 2 months (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy term 2-month-old infants for whom a parent/legal representative has given written informed consent.
Exclusion Criteria:
- Subjects with a previous or suspected disease caused by Neisseria meningitidis, Corynebacterium diphtheriae, Clostridium tetani, Poliovirus, Hepatitis B, Haemophilus influenzae type b (Hib), Pneumococcus or Bordetella pertussis; previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s) or prior vaccination with Diptheria, Tetanus, Pertussis (acellular or whole cell), inactivated polio vaccineIPV or oral polio vaccineOPV, H. influenzae type b (Hib) or Pneumococcus; who have had household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis (serogroups A, C, W-135, or Y), B. pertussis, Hib, C. diphtheriae, Polio, or pneumococcal infection at any time since birth; Any serious acute, chronic or progressive disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: US1A (MenACWY-CRM + Infant Vaccines)
Received vaccines: MenACWY: 2, 4, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months |
Other Names:
Other Names:
Other Names:
Other Names:
Other Names:
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Experimental: US1B (MenACWY-CRM + Infant Vaccines)
Received vaccines: MenACWY: 2, 4, 6, and 13 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months |
Other Names:
Other Names:
Other Names:
Other Names:
Other Names:
Other Names:
Other Names:
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Experimental: US2 (Infant Vaccines Only)
Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months |
Other Names:
Other Names:
Other Names:
Other Names:
Other Names:
Other Names:
Other Names:
|
|
Experimental: US3 (MenACWY-CRM + Infant Vaccines)
Received vaccines: MenACWY: 2, 4, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months |
Other Names:
Other Names:
Other Names:
Other Names:
Other Names:
Other Names:
Other Names:
|
|
Experimental: US4A (Infant Vaccines Only)
Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months |
Other Names:
Other Names:
Other Names:
Other Names:
Other Names:
Other Names:
|
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Experimental: US4B (Infant Vaccines Only)
Received vaccines: MenACWY: 13 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months |
Other Names:
Other Names:
Other Names:
Other Names:
Other Names:
Other Names:
Other Names:
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Experimental: US4C (Infant Vaccines Only)
Received vaccines: MenACWY: 18 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months |
Other Names:
Other Names:
Other Names:
Other Names:
Other Names:
Other Names:
Other Names:
|
|
Experimental: LA1A (MenACWY-CRM + Infant Vaccines)
Received vaccines: MenACWY: 2, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months |
Other Names:
Other Names:
Other Names:
Other Names:
Other Names:
Other Names:
Other Names:
|
|
Experimental: LA1B (MenACWY-CRM + Infant Vaccines)
Received vaccines: MenACWY: 2, 6, and 13 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months |
Other Names:
Other Names:
Other Names:
Other Names:
Other Names:
Other Names:
Other Names:
|
|
Experimental: LA2 (Infant Vaccines Only)
Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months |
Other Names:
Other Names:
Other Names:
Other Names:
Other Names:
Other Names:
Other Names:
|
|
Experimental: LA3A (MenACWY-CRM + Infant Vaccines)
Received vaccines: MenACWY: 2, 4, 6, and 16 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months DTaP, Hib: 16 months Pneumococcal, HAV, and MMR-V: 12 months |
Other Names:
Other Names:
Other Names:
Other Names:
Other Names:
Other Names:
Other Names:
Other Names:
|
|
Experimental: LA3B (MenACWY-CRM + Infant Vaccines)
Received vaccines: MenACWY: 2, 4, 6, and 17 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months DTaP, Hib: 16 months Pneumococcal, HAV, and MMR-V: 12 months |
Other Names:
Other Names:
Other Names:
Other Names:
Other Names:
Other Names:
Other Names:
Other Names:
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Experimental: LA4 (Infant Vaccines Only)
Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months DTaP, Hib: 15 months Pneumococcal, HAV, and MMR-V: 12 months |
Other Names:
Other Names:
Other Names:
Other Names:
Other Names:
Other Names:
Other Names:
Other Names:
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Experimental: LA5 (MenACWY-CRM + Infant Vaccines)
Received vaccines: MenACWY: 2, 4, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months |
Other Names:
Other Names:
Other Names:
Other Names:
Other Names:
Other Names:
Other Names:
|
|
Experimental: LA6A (Infant Vaccines Only)
Received vaccines: MenACWY: 12, and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months |
Other Names:
Other Names:
Other Names:
Other Names:
Other Names:
Other Names:
Other Names:
|
|
Experimental: LA6B (Infant Vaccines Only)
Received vaccines: MenACWY: 13 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months |
Other Names:
Other Names:
Other Names:
Other Names:
Other Names:
Other Names:
Other Names:
|
|
Experimental: LA6C (Infant Vaccines Only)
Received vaccines: MenACWY: 18 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months |
Other Names:
Other Names:
Other Names:
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of Subjects With hSBA Titer >=1:8 - US Subjects
Time Frame: 13 months of age (one month post-toddler vaccination)
|
Immunogenicity as measured by percentage of subjects with hSBA titer >=1:8 directed against N. meningitidis serogroups A, C, W and Y; after four doses of MenACWY-CRM at 2, 4, and 6 and 12 months of age
|
13 months of age (one month post-toddler vaccination)
|
|
Geometric Mean hSBA Titers - US Subjects
Time Frame: 13 months of age (one month post-toddler vaccination)
|
Immunogenicity as measured by Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y; comparison of four doses of MenACWY-CRM at 2, 4, and 6 and 12 months of age versus a single dose at 12 months of age.
|
13 months of age (one month post-toddler vaccination)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series
Time Frame: 7 days after vaccination
|
Solicited local and systemic reactions post first vaccination of infant series were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines.
|
7 days after vaccination
|
|
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series
Time Frame: 7 days after vaccination
|
Solicited local and systemic reactions post second vaccination of infant series were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines.
|
7 days after vaccination
|
|
Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series
Time Frame: 7 days after vaccination
|
Solicited local and systemic reactions post third vaccination of infant series were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines.
|
7 days after vaccination
|
|
Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age
Time Frame: 7 days after vaccination
|
Solicited local and systemic reactions after receiving MenACWY-CRM vaccination at 12 months of age were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines.
|
7 days after vaccination
|
|
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series
Time Frame: 7 days post vaccination
|
Solicited local and systemic reactions post first vaccination of toddler series were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines.
|
7 days post vaccination
|
|
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series
Time Frame: 7 days post vaccination
|
Solicited local and systemic reactions post second vaccination of toddler series at 15 months of age.
|
7 days post vaccination
|
|
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series
Time Frame: 7 days post-vaccination
|
Solicited local and systemic reactions reported post first vaccination was compared in subjects receiving MenACWY versus Hib Vaccines.
|
7 days post-vaccination
|
|
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series
Time Frame: 7 days post-vaccination
|
Solicited local and systemic reactions reported post second vaccination was compared in subjects receiving MenACWY versus Hib Vaccines.
|
7 days post-vaccination
|
|
Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series
Time Frame: 7 days post-vaccination
|
Solicited local and systemic reactions reported post third vaccination was compared in subjects receiving MenACWY versus Hib Vaccines.
|
7 days post-vaccination
|
|
Geometric Mean hSBA Titers Post-infant Series - US Subjects
Time Frame: 7 months of age (one month post-infant series)
|
Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y was measured after three doses at 2, 4, and 6 months of age.
|
7 months of age (one month post-infant series)
|
|
Geometric Mean hSBA Titers Post-infant Series - LA Subjects
Time Frame: 7 months of age (one month post-infant series)
|
Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y was measured after two doses of MenACWY at 2 and 6 months (LA1) versus three doses at 2, 4, and 6 (LA3) months of age.
|
7 months of age (one month post-infant series)
|
|
Percentage of Subjects With hSBA Titer >=1:8 - US Subjects
Time Frame: 7 months of age (one month post-infant series)
|
Immunogenicity as measured by percentage of subjects with hSBA titer >=1:8 directed against N. meningitidis serogroups A, C, W and Y; after three doses of MenACWY at 2, 4, and 6 months of age.
|
7 months of age (one month post-infant series)
|
|
Percentage of Subjects With hSBA Titer >=1:4 - US Subjects
Time Frame: 7 months of age (one month post-infant series)
|
Immunogenicity as measured by percentage of subjects with hSBA titer >=1:4 directed against N. meningitidis serogroups A, C, W and Y; after three doses of MenACWY at 2, 4, and 6 months of age.
|
7 months of age (one month post-infant series)
|
|
Percentage of Subjects With hSBA Titer >=1:8 - LA Subjects
Time Frame: 7 months of age (one month post-infant series)
|
Immunogenicity as measured by percentage of subjects with hSBA titer >=1:8 directed against N. meningitidis serogroups A, C, W and Y; after two doses of MenACWY at 2 and 6 months (LA1) versus three doses at 2, 4, and 6 months of age (LA3) .
|
7 months of age (one month post-infant series)
|
|
Percentage of Subjects With hSBA Titer >=1:4 - LA Subjects
Time Frame: 7 months of age (one month post-infant series)
|
Immunogenicity as measured by percentage of subjects with hSBA titer >=1:4 directed against N. meningitidis serogroups A, C, W and Y; after two doses of MenACWY at 2 and 6 months (LA1) versus three doses at 2, 4, and 6 months of age (LA3) .
|
7 months of age (one month post-infant series)
|
|
Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects
Time Frame: 7 months of age (one month post-infant series)
|
Immunogenicity as measured by antibody GMCs / GMTs directed against DTaP, HBV, Hib, pneumococcal and polio antigens.
|
7 months of age (one month post-infant series)
|
|
Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects
Time Frame: 7 months of age (one month post-infant series)
|
Immunogenicity as measured by percentage of subjects with predefined seroprotective antibody titers against DTaP, HBV, Hib, pneumococcal and polio antigens.
|
7 months of age (one month post-infant series)
|
|
Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects
Time Frame: 7 months of age (one month post-infant series)
|
Immunogenicity as measured by antibody GMCs / GMTs directed against DTaP, HBV, Hib, pneumococcal and polio antigens.
|
7 months of age (one month post-infant series)
|
|
Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects
Time Frame: 7 months of age (one month post-infant series)
|
Immunogenicity as measured by percentage of subjects with predefined seroprotective antibody titers against DTaP, HBV, Hib, pneumococcal and polio antigens.
|
7 months of age (one month post-infant series)
|
|
Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 Months of Age- US Subject
Time Frame: 12 Months of Age (one month pre-toddler vaccination)
|
Persistence of Antibodies as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:4, directed against N.meningitidis serogroups A, C, W and Y.
|
12 Months of Age (one month pre-toddler vaccination)
|
|
Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 Months of Age- US Subject
Time Frame: 12 Months of Age (one month pre-toddler vaccination)
|
Persistence of Antibodies as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8, directed against N.meningitidis serogroups A, C, W and Y.
|
12 Months of Age (one month pre-toddler vaccination)
|
|
Persistence Antibodies Geometric Mean Titers - US Subject
Time Frame: 12 Months of Age (one month pre-toddler vaccination)
|
Geometric Mean hSBA Titers directed against N. meningitides serogroups A, C, W and Y was measured at 12 Months of Age.
|
12 Months of Age (one month pre-toddler vaccination)
|
|
Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 or 16 Months of Age- LA Subject
Time Frame: 12 or 16 Months of Age (one month pre-toddler vaccination)
|
Persistence of Antibodies as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:4, directed against N.meningitidis serogroups A, C, W and Y.
|
12 or 16 Months of Age (one month pre-toddler vaccination)
|
|
Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 or 16 Months of Age- LA Subject
Time Frame: 12 or 16 Months of Age (one month pre-toddler vaccination)
|
Persistence of Antibodies as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8, directed against N.meningitidis serogroups A, C, W and Y.
|
12 or 16 Months of Age (one month pre-toddler vaccination)
|
|
Persistence Antibodies Geometric Mean Titers - LA Subjects
Time Frame: 12 or 16 Months of Age (one month pre-toddler vaccination)
|
Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y was measured at 12 or 16 Months of Age.
|
12 or 16 Months of Age (one month pre-toddler vaccination)
|
|
Percentage of Subjects (95% CI) With hSBA ≥ 1:4 at 1 Month After Toddler MenACWY Vaccination - US Subjects
Time Frame: 13 months of age (one month post-toddler vaccination)
|
Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:4 , directed against N.meningitidis serogroups A, C, W and Y.
|
13 months of age (one month post-toddler vaccination)
|
|
Percentage of Subjects (95% CI) With hSBA ≥ 1:8 at 1 Month After Toddler MenACWY Vaccination - US Subjects
Time Frame: 13 months of age (one month post-toddler vaccination)
|
Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8 , directed against N.meningitidis serogroups A, C, W and Y.
|
13 months of age (one month post-toddler vaccination)
|
|
Percentage of Subjects (95% CI) With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - US Subjects
Time Frame: 13 months of age (one month post-toddler vaccination)
|
Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:16 , directed against N.meningitidis serogroups A, C, W and Y.
|
13 months of age (one month post-toddler vaccination)
|
|
Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - US Subjects
Time Frame: 13 months of age (one month post-toddler vaccination)
|
Immunogenicity as measured by Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y; comparison of four doses of MenACWY-CRM at 2, 4, and 6 and 12 months of age versus a single dose at 12 months of age.
|
13 months of age (one month post-toddler vaccination)
|
|
Percentage of Subjects (95% CI) With hSBA ≥1:4 at 1 Month After Toddler MenACWY Vaccination - LA Subjects
Time Frame: 13 or 17 Months of Age (one month post-toddler vaccination)
|
Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:4, directed against N. meningitidis serogroups A, C, W and Y.
|
13 or 17 Months of Age (one month post-toddler vaccination)
|
|
Percentage of Subjects (95% CI) With hSBA ≥1:8 at 1 Month After Toddler MenACWY Vaccination - LA Subjects
Time Frame: 13 or 17 Months of Age (one month post-toddler vaccination)
|
Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8, directed against N. meningitidis serogroups A, C, W and Y.
|
13 or 17 Months of Age (one month post-toddler vaccination)
|
|
Percentage of Subjects With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - LA Subjects
Time Frame: 13 or 17 Months of Age (one month post-toddler vaccination)
|
Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:16, directed against N. meningitidis serogroups A, C, W and Y.
|
13 or 17 Months of Age (one month post-toddler vaccination)
|
|
Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - LA Subjects
Time Frame: 13 or 17 Months of Age (one month post-toddler vaccination)
|
Immunogenicity as measured by Serum bactericidal activity using human complement (hSBA) GMTs, directed against N. meningitidis serogroups A, C, W and Y.
|
13 or 17 Months of Age (one month post-toddler vaccination)
|
|
Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - US Subjects
Time Frame: 13 months of age (one month post-toddler vaccination)
|
Immunogenicity as measured by antibody GMTs, directed against pneumococcal antigens PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F and PnC 23F.
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13 months of age (one month post-toddler vaccination)
|
|
Percentage of Subjects With Pneumococcal Antibody GMCs ≥1.0 μg/mL at 1 Month After Toddler Vaccination - US Subjects
Time Frame: 13 months of age (one month post-toddler vaccination)
|
Immunogenicity as measured by Percentage of Subjects with Pneumococcal Antibody GMCs ≥1.0 μg/mL directed against pneumococcal antigens PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F and PnC 23F.
|
13 months of age (one month post-toddler vaccination)
|
|
Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - LA Subjects
Time Frame: 13 months of age (one month post-toddler vaccination)
|
Immunogenicity as measured by antibody GMTs, directed against pneumococcal antigens PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F and PnC 23F.
|
13 months of age (one month post-toddler vaccination)
|
|
Percentage of Subjects With Pneumococcal Antibody Concentration ≥1.0 μg/mL at 1 Month After Toddler Vaccination - LA Subjects
Time Frame: 13 months of age (one month post-toddler vaccination)
|
Immunogenicity as measured by Percentage of Subjects with Pneumococcal Antibody GMCs ≥1.0 μg/mL directed against pneumococcal antigens PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F and PnC 23F
|
13 months of age (one month post-toddler vaccination)
|
|
Geometric Mean Concentrations or Titers of DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects
Time Frame: 17 months of age (one month post-toddler vaccination)
|
Immunogenicity as measured by antibody GMCs/GMTs, directed against DTaP and Hib Antigens
|
17 months of age (one month post-toddler vaccination)
|
|
Seroresponse Rates to DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects
Time Frame: 17 months of age (one month post-toddler vaccination)
|
Immunogenicity as measured by Percentage of Subjects with predefined seroprotective antibody titers against DTaP and Hib Antigens
|
17 months of age (one month post-toddler vaccination)
|
|
Percentage of Subjects With hSBA ≥1:8 at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects
Time Frame: 12 or 15 months of age (one month post 1st or 2nd toddler vaccination)
|
Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8, directed against N.meningitidis serogroups A, C, W and Y.
|
12 or 15 months of age (one month post 1st or 2nd toddler vaccination)
|
|
Geometric Mean hSBA Titers at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects
Time Frame: 12 or 15 months of age (one month post 1st or 2nd toddler vaccination)
|
Immunogenicity as measured by Serum bactericidal activity using human complement (hSBA) GMTs, directed against N. meningitidis serogroups A, C, W and Y.
|
12 or 15 months of age (one month post 1st or 2nd toddler vaccination)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Novartis - Vaccines, Novartis Vaccines & Diagnostics
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2007
Primary Completion (Actual)
September 1, 2008
Study Completion (Actual)
November 1, 2009
Study Registration Dates
First Submitted
May 16, 2007
First Submitted That Met QC Criteria
May 16, 2007
First Posted (Estimate)
May 17, 2007
Study Record Updates
Last Update Posted (Estimate)
March 24, 2014
Last Update Submitted That Met QC Criteria
February 24, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Central Nervous System Diseases
- Nervous System Diseases
- Infections
- Central Nervous System Infections
- Gram-Negative Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Meningitis, Bacterial
- Central Nervous System Bacterial Infections
- Meningococcal Infections
- Neisseriaceae Infections
- Meningitis, Meningococcal
- Meningitis
- Physiological Effects of Drugs
- Immunologic Factors
- Vaccines
- Heptavalent Pneumococcal Conjugate Vaccine
Other Study ID Numbers
- V59P14
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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