A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Infants

NCT00474526 | Completed Phase 3 Results

• 1 other identifier: V59P14
• Study Type: interventional
• Target: 4,545
• Locations: 3 countries
• Sites: 63

Brief Summary

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.

Conditions

Meningitis, Meningococcal

Keywords

Meningococcal; meningitis; vaccine; infants; Meningococcal meningitis; Meningococcal disease

Outcome Measures

Primary Outcomes (2)

• Percentage of Subjects With hSBA Titer >=1:8 - US Subjects

  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

  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 Outcomes (41)

• Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series

  7 days after vaccination

• Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series

  7 days after vaccination

• Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series

  7 days after vaccination

• Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age

  7 days after vaccination

• Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series

  7 days post vaccination

Study Arms (17)

US1A (MenACWY-CRM + Infant Vaccines)

EXPERIMENTAL

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

Biological: Meningococcal ACWY Conjugate Vaccine; Biological: DTaP-IPV-HBV; Biological: Hib; Biological: Rotavirus; Biological: Pneumococcal 7-valent Conjugate Vaccine; Biological: HAV; Biological: MMR-V

US1B (MenACWY-CRM + Infant Vaccines)

EXPERIMENTAL

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

Biological: Meningococcal ACWY Conjugate Vaccine; Biological: DTaP-IPV-HBV; Biological: Hib; Biological: Rotavirus; Biological: Pneumococcal 7-valent Conjugate Vaccine; Biological: HAV; Biological: MMR-V

US2 (Infant Vaccines Only)

EXPERIMENTAL

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

Biological: Meningococcal ACWY Conjugate Vaccine; Biological: DTaP-IPV-HBV; Biological: Hib; Biological: Rotavirus; Biological: Pneumococcal 7-valent Conjugate Vaccine; Biological: HAV; Biological: MMR-V

US3 (MenACWY-CRM + Infant Vaccines)

EXPERIMENTAL

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

Biological: Meningococcal ACWY Conjugate Vaccine; Biological: DTaP-IPV-HBV; Biological: Hib; Biological: Rotavirus; Biological: Pneumococcal 7-valent Conjugate Vaccine; Biological: HAV; Biological: MMR-V

US4A (Infant Vaccines Only)

EXPERIMENTAL

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

Biological: Meningococcal ACWY Conjugate Vaccine; Biological: DTaP-IPV-HBV; Biological: Hib; Biological: Rotavirus; Biological: HAV; Biological: MMR-V

US4B (Infant Vaccines Only)

EXPERIMENTAL

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

Biological: Meningococcal ACWY Conjugate Vaccine; Biological: DTaP-IPV-HBV; Biological: Hib; Biological: Rotavirus; Biological: Pneumococcal 7-valent Conjugate Vaccine; Biological: HAV; Biological: MMR-V

US4C (Infant Vaccines Only)

EXPERIMENTAL

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

Biological: Meningococcal ACWY Conjugate Vaccine; Biological: DTaP-IPV-HBV; Biological: Hib; Biological: Rotavirus; Biological: Pneumococcal 7-valent Conjugate Vaccine; Biological: HAV; Biological: MMR-V

LA1A (MenACWY-CRM + Infant Vaccines)

EXPERIMENTAL

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

Biological: Meningococcal ACWY Conjugate Vaccine; Biological: DTaP-IPV-HBV; Biological: Hib; Biological: Rotavirus; Biological: Pneumococcal 7-valent Conjugate Vaccine; Biological: HAV; Biological: MMR-V

LA1B (MenACWY-CRM + Infant Vaccines)

EXPERIMENTAL

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

Biological: Meningococcal ACWY Conjugate Vaccine; Biological: DTaP-IPV-HBV; Biological: Hib; Biological: Rotavirus; Biological: Pneumococcal 7-valent Conjugate Vaccine; Biological: HAV; Biological: MMR-V

LA2 (Infant Vaccines Only)

EXPERIMENTAL

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

Biological: Meningococcal ACWY Conjugate Vaccine; Biological: DTaP-IPV-HBV; Biological: Hib; Biological: Rotavirus; Biological: Pneumococcal 7-valent Conjugate Vaccine; Biological: HAV; Biological: MMR-V

LA3A (MenACWY-CRM + Infant Vaccines)

EXPERIMENTAL

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

Biological: Meningococcal ACWY Conjugate Vaccine; Biological: DTaP-IPV-HBV; Biological: Hib; Biological: Rotavirus; Biological: Pneumococcal 7-valent Conjugate Vaccine; Biological: HAV; Biological: MMR-V; Biological: DTaP

LA3B (MenACWY-CRM + Infant Vaccines)

EXPERIMENTAL

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

Biological: Meningococcal ACWY Conjugate Vaccine; Biological: DTaP-IPV-HBV; Biological: Hib; Biological: Rotavirus; Biological: Pneumococcal 7-valent Conjugate Vaccine; Biological: HAV; Biological: MMR-V; Biological: DTaP

LA4 (Infant Vaccines Only)

EXPERIMENTAL

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

Biological: Meningococcal ACWY Conjugate Vaccine; Biological: DTaP-IPV-HBV; Biological: Hib; Biological: Rotavirus; Biological: Pneumococcal 7-valent Conjugate Vaccine; Biological: HAV; Biological: MMR-V; Biological: DTaP

LA5 (MenACWY-CRM + Infant Vaccines)

EXPERIMENTAL

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

Biological: Meningococcal ACWY Conjugate Vaccine; Biological: DTaP-IPV-HBV; Biological: Hib; Biological: Rotavirus; Biological: Pneumococcal 7-valent Conjugate Vaccine; Biological: HAV; Biological: MMR-V

LA6A (Infant Vaccines Only)

EXPERIMENTAL

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

Biological: Meningococcal ACWY Conjugate Vaccine; Biological: DTaP-IPV-HBV; Biological: Hib; Biological: Rotavirus; Biological: Pneumococcal 7-valent Conjugate Vaccine; Biological: HAV; Biological: MMR-V

LA6B (Infant Vaccines Only)

EXPERIMENTAL

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

Biological: Meningococcal ACWY Conjugate Vaccine; Biological: DTaP-IPV-HBV; Biological: Hib; Biological: Rotavirus; Biological: Pneumococcal 7-valent Conjugate Vaccine; Biological: HAV; Biological: MMR-V

LA6C (Infant Vaccines Only)

EXPERIMENTAL

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

Biological: Meningococcal ACWY Conjugate Vaccine; Biological: DTaP-IPV-HBV; Biological: Hib; Biological: Rotavirus; Biological: Pneumococcal 7-valent Conjugate Vaccine; Biological: HAV

Interventions

Meningococcal ACWY Conjugate Vaccine BIOLOGICAL

Also known as: Menveo

LA1A (MenACWY-CRM + Infant Vaccines); LA1B (MenACWY-CRM + Infant Vaccines); LA2 (Infant Vaccines Only); LA3A (MenACWY-CRM + Infant Vaccines); LA3B (MenACWY-CRM + Infant Vaccines); LA4 (Infant Vaccines Only); LA5 (MenACWY-CRM + Infant Vaccines); LA6A (Infant Vaccines Only); LA6B (Infant Vaccines Only); LA6C (Infant Vaccines Only); US1A (MenACWY-CRM + Infant Vaccines); US1B (MenACWY-CRM + Infant Vaccines); US2 (Infant Vaccines Only); US3 (MenACWY-CRM + Infant Vaccines); US4A (Infant Vaccines Only); US4B (Infant Vaccines Only); US4C (Infant Vaccines Only)

DTaP-IPV-HBV BIOLOGICAL

Also known as: Pediarix® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined

LA1A (MenACWY-CRM + Infant Vaccines); LA1B (MenACWY-CRM + Infant Vaccines); LA2 (Infant Vaccines Only); LA3A (MenACWY-CRM + Infant Vaccines); LA3B (MenACWY-CRM + Infant Vaccines); LA4 (Infant Vaccines Only); LA5 (MenACWY-CRM + Infant Vaccines); LA6A (Infant Vaccines Only); LA6B (Infant Vaccines Only); LA6C (Infant Vaccines Only); US1A (MenACWY-CRM + Infant Vaccines); US1B (MenACWY-CRM + Infant Vaccines); US2 (Infant Vaccines Only); US3 (MenACWY-CRM + Infant Vaccines); US4A (Infant Vaccines Only); US4B (Infant Vaccines Only); US4C (Infant Vaccines Only)

Hib BIOLOGICAL

Also known as: ActHIB® (Haemophilus influenzae type b Conjugate Vaccine)

LA1A (MenACWY-CRM + Infant Vaccines); LA1B (MenACWY-CRM + Infant Vaccines); LA2 (Infant Vaccines Only); LA3A (MenACWY-CRM + Infant Vaccines); LA3B (MenACWY-CRM + Infant Vaccines); LA4 (Infant Vaccines Only); LA5 (MenACWY-CRM + Infant Vaccines); LA6A (Infant Vaccines Only); LA6B (Infant Vaccines Only); LA6C (Infant Vaccines Only); US1A (MenACWY-CRM + Infant Vaccines); US1B (MenACWY-CRM + Infant Vaccines); US2 (Infant Vaccines Only); US3 (MenACWY-CRM + Infant Vaccines); US4A (Infant Vaccines Only); US4B (Infant Vaccines Only); US4C (Infant Vaccines Only)

Rotavirus BIOLOGICAL

Also known as: RotaTeq® Rotavirus Vaccine, Live, Oral, Pentavalent

LA1A (MenACWY-CRM + Infant Vaccines); LA1B (MenACWY-CRM + Infant Vaccines); LA2 (Infant Vaccines Only); LA3A (MenACWY-CRM + Infant Vaccines); LA3B (MenACWY-CRM + Infant Vaccines); LA4 (Infant Vaccines Only); LA5 (MenACWY-CRM + Infant Vaccines); LA6A (Infant Vaccines Only); LA6B (Infant Vaccines Only); LA6C (Infant Vaccines Only); US1A (MenACWY-CRM + Infant Vaccines); US1B (MenACWY-CRM + Infant Vaccines); US2 (Infant Vaccines Only); US3 (MenACWY-CRM + Infant Vaccines); US4A (Infant Vaccines Only); US4B (Infant Vaccines Only); US4C (Infant Vaccines Only)

Pneumococcal 7-valent Conjugate Vaccine BIOLOGICAL

Also known as: Prevnar®

LA1A (MenACWY-CRM + Infant Vaccines); LA1B (MenACWY-CRM + Infant Vaccines); LA2 (Infant Vaccines Only); LA3A (MenACWY-CRM + Infant Vaccines); LA3B (MenACWY-CRM + Infant Vaccines); LA4 (Infant Vaccines Only); LA5 (MenACWY-CRM + Infant Vaccines); LA6A (Infant Vaccines Only); LA6B (Infant Vaccines Only); LA6C (Infant Vaccines Only); US1A (MenACWY-CRM + Infant Vaccines); US1B (MenACWY-CRM + Infant Vaccines); US2 (Infant Vaccines Only); US3 (MenACWY-CRM + Infant Vaccines); US4B (Infant Vaccines Only); US4C (Infant Vaccines Only)

HAV BIOLOGICAL

Also known as: Havrix® (Hepatitis A Vaccine, Inactivated)

LA1A (MenACWY-CRM + Infant Vaccines); LA1B (MenACWY-CRM + Infant Vaccines); LA2 (Infant Vaccines Only); LA3A (MenACWY-CRM + Infant Vaccines); LA3B (MenACWY-CRM + Infant Vaccines); LA4 (Infant Vaccines Only); LA5 (MenACWY-CRM + Infant Vaccines); LA6A (Infant Vaccines Only); LA6B (Infant Vaccines Only); LA6C (Infant Vaccines Only); US1A (MenACWY-CRM + Infant Vaccines); US1B (MenACWY-CRM + Infant Vaccines); US2 (Infant Vaccines Only); US3 (MenACWY-CRM + Infant Vaccines); US4A (Infant Vaccines Only); US4B (Infant Vaccines Only); US4C (Infant Vaccines Only)

MMR-V BIOLOGICAL

Also known as: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine)

LA1A (MenACWY-CRM + Infant Vaccines); LA1B (MenACWY-CRM + Infant Vaccines); LA2 (Infant Vaccines Only); LA3A (MenACWY-CRM + Infant Vaccines); LA3B (MenACWY-CRM + Infant Vaccines); LA4 (Infant Vaccines Only); LA5 (MenACWY-CRM + Infant Vaccines); LA6A (Infant Vaccines Only); LA6B (Infant Vaccines Only); US1A (MenACWY-CRM + Infant Vaccines); US1B (MenACWY-CRM + Infant Vaccines); US2 (Infant Vaccines Only); US3 (MenACWY-CRM + Infant Vaccines); US4A (Infant Vaccines Only); US4B (Infant Vaccines Only); US4C (Infant Vaccines Only)

DTaP BIOLOGICAL

Also known as: Infanrix® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed)

LA3A (MenACWY-CRM + Infant Vaccines); LA3B (MenACWY-CRM + Infant Vaccines); LA4 (Infant Vaccines Only)

Eligibility Criteria

• Age: 2 Months - 2 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy term 2-month-old infants for whom a parent/legal representative has given written informed consent.

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Vaccines: lead

Study Sites (63)

Growing Up Pediatrics

Bessemer, Alabama, 35022, United States

Location

Alabama Clinical Therapeutics, LLC

Birmingham, Alabama, 03523, United States

Location

Growing Up Pediatrics

Birmingham, Alabama, 35242, United States

Location

Premier Health Research Center, LLC

Downey, California, 90241, United States

Location

Kaiser Permanente Oakland

Oakland, California, 94611, United States

Location

Kaiser Permanente Med Group - Vaccine Study Ctr

Oakland, California, 94612, United States

Location

Center for Clinical Trials, LLC

Paramount, California, 90723, United States

Location

Kaiser Permanente Pleasanton

Pleasanton, California, 94588, United States

Location

Kaiser Permanente Richmond

Richmond, California, 94801, United States

Location

Kaiser Permanente San Francisco

San Francisco, California, 94115, United States

Location

Kaiser Permanente Santa Clara

Santa Clara, California, 95051, United States

Location

UCLA Center for Vaccine Research

Torrence, California, 90502, United States

Location

The Children's Hospital

Aurora, Colorado, 80045, United States

Location

Longmont Medical Research Network

Longmont, Colorado, 80501, United States

Location

Children's Memorial Hospital

Chicago, Illinois, 60614-3394, United States

Location

Kentucky Pediatric/Adult Research Inc.

Bardstown, Kentucky, 40004, United States

Location

Annapolis Pediatrics

Annapolis, Maryland, 21401, United States

Location

Center for Vaccine Development

Baltimore, Maryland, 21201, United States

Location

The Pediatric Center

Frederick, Maryland, 21702, United States

Location

Boston University Medical Center

Boston, Massachusetts, 02118, United States

Location

Pediatric Associates of Fall River

Fall River, Massachusetts, 02724, United States

Location

Creighton University

Omaha, Nebraska, 68131, United States

Location

Children's Physicians Dundee

Omaha, Nebraska, 68132, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Akron Children's Hospital

Akron, Ohio, 44308, United States

Location

Louis P. Brine, Jr., MD, Beeghley Medical Park

Boardman, Ohio, 44512, United States

Location

Senders Pediatric Research at Dr. Senders and Associates

Cleveland, Ohio, 44118, United States

Location

Carnegie Pediatrics

Carnegie, Pennsylvania, 15106, United States

Location

Children's Health Care - West

Erie, Pennsylvania, 16505, United States

Location

UPMC/Community Medicine, Inc.

Greenville, Pennsylvania, 16125, United States

Location

Family Healthcare Partners

Grove City, Pennsylvania, 16127, United States

Location

Pennridge Pediatric Associates

Harleyville, Pennsylvania, 19438, United States

Location

Pediatric Associates of Latrobe

Latrobe, Pennsylvania, 15650, United States

Location

Pediatric Medical Associates

Norristown, Pennsylvania, 19401, United States

Location

Squirrel Hill Office

Pittsburgh, Pennsylvania, 15217, United States

Location

Pediatric Alliance, Greentree Division

Pittsburgh, Pennsylvania, 15220, United States

Location

South Hills Pediatrics

Pittsburgh, Pennsylvania, 15227, United States

Location

Pediatric Alliance, Southwestern

Pittsburgh, Pennsylvania, 15236, United States

Location

Primary Physicians Research, Inc

Pittsburgh, Pennsylvania, 15241, United States

Location

Pediatrics Medical Associates

Rydal, Pennsylvania, 19046, United States

Location

Pennridge Pediatric Associates

Sellersville, Pennsylvania, 18960, United States

Location

Laurel Pediatrics

Uniontown, Pennsylvania, 15401, United States

Location

CCP - Pittsburgh Pediatrics

Wexford, Pennsylvania, 15090, United States

Location

Goodlettsville Pediatrics

Madison, Tennessee, 37115-2154, United States

Location

Research Across America

Dallas, Texas, 75234, United States

Location

Mercury Pharma Services

Houston, Texas, 77024, United States

Location

Scott and White Hospital

Temple, Texas, 76508, United States

Location

Wee Care Pediatrics

Layton, Utah, 84041, United States

Location

Utah Valley Pediatrics - Timpanogos

Orem, Utah, 84057, United States

Location

Foothill Family Clinic

Salt Lake City, Utah, 84121, United States

Location

Copperview Medical Center

South Jordan, Utah, 84095, United States

Location

Monroe Medical Foundation

Monroe, Wisconsin, 53566, United States

Location

CEDEPAP Rio IV

Alvear 1439 PB Dpto, Rio IV, Cordoba, Córdoba Province, Argentina

Location

Hospitales Materno Neonatal,

Castro Barros 650 - Barrio San Martin, Cordoba, Córdoba Province, Argentina

Location

CdePAP, Centro De Desarrollo De Proyectos Avanzados Roma 1465,

Córdoba, Córdoba Province, X5000BJH, Argentina

Location

Hospital Regional Luis Pasteur,

Mendoza N°2152, Villa Maria, Cordoba,, Córdoba Province, Argentina

Location

Buenos Aires, Argentina

Buenos Aires, C1406DGI, Argentina

Location

Centro Estudios Infect

Scalabrini Ortiz 676, Buenos Aires, Buenos Aires,, Argentina

Location

Siloe

Calle 1 #50-51, Cali, 405, Colombia

Location

Comfenalco

Calle 6#5-42, Cali, 405, Colombia

Location

Hospital C H Trujillo

Calle 72U 28 F-00, Cali, 405, Colombia

Location

Corporation Cientifica

Ped Calle 5B5 No.37 Bis-28, Cali, 405, Colombia

Location

Related Publications (1)

• Klein NP, Reisinger KS, Johnston W, Odrljin T, Gill CJ, Bedell L, Dull P. Safety and immunogenicity of a novel quadrivalent meningococcal CRM-conjugate vaccine given concomitantly with routine vaccinations in infants. Pediatr Infect Dis J. 2012 Jan;31(1):64-71. doi: 10.1097/INF.0b013e31823dce5c.

  PMID: 22094635 RESULT

MeSH Terms

Conditions

Meningitis, Meningococcal; Meningitis; Meningococcal Infections

Interventions

Meningococcal Vaccines; diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine; PEDIARIX; Tetanus Toxoid; Hepatitis B Vaccines; Haemophilus influenza type b polysaccharide vaccine-tetanus toxin conjugate; Pneumococcal Vaccines; Heptavalent Pneumococcal Conjugate Vaccine; Hepatitis A Vaccines; measles, mumps, rubella, varicella vaccine; Chickenpox Vaccine; Diphtheria-Tetanus-acellular Pertussis Vaccines

Condition Hierarchy (Ancestors)

Meningitis, Bacterial; Central Nervous System Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases

Intervention Hierarchy (Ancestors)

Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Toxoids; Viral Hepatitis Vaccines; Viral Vaccines; Streptococcal Vaccines; Vaccines, Combined; Herpesvirus Vaccines; Pertussis Vaccine; Diphtheria Toxoid; Vaccines, Acellular; Vaccines, Subunit

Results Point of Contact

• Title: Posting Director
• Organization: Novartis Vaccines and Diagnostics

RegistryContactVaccinesUS@novartis.com

Study Officials

• Novartis - Vaccines

  Novartis Vaccines & Diagnostics

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2007
• First Posted: May 17, 2007
• Study Start: March 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: November 1, 2009
• Last Updated: March 24, 2014
• Results First Posted: March 24, 2014

Record last verified: 2014-02

Locations

US (53); CO (4); AR (6)