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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00474526
First received: May 16, 2007
Last updated: October 17, 2012
Last verified: October 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Meningitis, Meningococcal
 Biological: Meningococcal ACWY Conjugate Vaccine
Biological: DTaP-IPV-HBV
Biological: Hib
Biological: rotavirus
Biological: Pneumococcal 7-valent Conjugate Vaccine
Biological: HAV
Biological: MMR
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Immunogenicity of four doses of MenACWY ( US subjects) [ Time Frame: 2, 4, 6 and 12 months of age ] [ Designated as safety issue: No ]
    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.

  • To compare the immunogenicity of the fourth dose (US infants received 3 doses at 2, 4 and 6 months) to single dose (US naive infants received one dose at 12 months)of MenACWY [ Time Frame: 12 months of age ] [ Designated as safety issue: No ]
    Immunogenicity as measured by the ratio of GMTs,directed against N. meningitidis serogroups A, C, W, and Y


Secondary Outcome Measures:
  • Immunogenicity of three doses of MenACWY (US subjects) [ Time Frame: at 2, 4 and 6 months of age ] [ Designated as safety issue: No ]
    Immunogenicity measured by hSBA geometric mean titers (GMTs) and by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8 and ≥ 1:4, directed against N. meningitidis serogroups A, C, W and Y (US subjects);

  • To compare the immunogenicity of two doses of MenACWY given to infants (Latin American) at 2 and 6 months of age to three doses of MenACWY given to infants at 2, 4, and 6 months of age [ Time Frame: 2, 4 and 6 months ] [ Designated as safety issue: No ]
    Immunogenicity as measured by hSBA GMTs and by the percentage of subjects with hSBA ≥1:4 and hSBA ≥ 1:8, directed against N. meningitidis serogroups A, C, W, and Y


Enrollment: 4545
Study Start Date: March 2007
Study Completion Date: November 2009
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: US1A (MenACWY-CRM + Infant Vaccines)
Along with Meningococcal ACWY Conjugate Vaccine infants received pediatric vaccines DTaP-IPV-HBV, Hib, rotavirus, HAV, MMR-V and pneumococcal conjugate vaccines at varying schedules.
 Biological: Meningococcal ACWY Conjugate Vaccine
MenACWY was administered at 2, 4, 6, 12 or 13, 15, 16 or 17, and 18 months.
Other Name: Menveo
Biological: DTaP-IPV-HBV
DTaP-IPV-HBV was administered at 2, 4, 6, and 16 months.
Other Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined; Pediarix
Biological: Hib
Hib was administered at 2, 4, 6, and 16 months.
Other Name: ActHIB; Haemophilus influenzae type b Conjugate Vaccine
Biological: rotavirus
Rotavirus was administered at 2, 4, and 6 months
Biological: Pneumococcal 7-valent Conjugate Vaccine
Pneumococcal 7-valent Conjugate Vaccine was administered at 2, 4, 6, 12 or 13 months.
Other Name: Prevnar
Biological: HAV
Hepatitis A Vaccine, Inactivated was administered at 12 or 13 months.
Other Name: Havrix; Hepatitis A Vaccine, Inactivated
Biological: MMR
MMR was administered at 12 or 13 months.
Other Name: Measles, Mumps and Rubella vaccine
Experimental: US1B (MenACWY-CRM + Infant Vaccines)
Along with Meningococcal ACWY Conjugate Vaccine infants received pediatric vaccines DTaP-IPV-HBV, Hib, rotavirus, HAV, MMR-V and pneumococcal conjugate vaccines at varying schedules.
 Biological: Meningococcal ACWY Conjugate Vaccine
MenACWY was administered at 2, 4, 6, 12 or 13, 15, 16 or 17, and 18 months.
Other Name: Menveo
Biological: DTaP-IPV-HBV
DTaP-IPV-HBV was administered at 2, 4, 6, and 16 months.
Other Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined; Pediarix
Biological: Hib
Hib was administered at 2, 4, 6, and 16 months.
Other Name: ActHIB; Haemophilus influenzae type b Conjugate Vaccine
Biological: rotavirus
Rotavirus was administered at 2, 4, and 6 months
Biological: Pneumococcal 7-valent Conjugate Vaccine
Pneumococcal 7-valent Conjugate Vaccine was administered at 2, 4, 6, 12 or 13 months.
Other Name: Prevnar
Biological: HAV
Hepatitis A Vaccine, Inactivated was administered at 12 or 13 months.
Other Name: Havrix; Hepatitis A Vaccine, Inactivated
Biological: MMR
MMR was administered at 12 or 13 months.
Other Name: Measles, Mumps and Rubella vaccine
Experimental: US2 (Infant Vaccines Only)
Along with Meningococcal ACWY Conjugate Vaccine infants received pediatric vaccines DTaP-IPV-HBV, Hib, rotavirus, HAV, MMR-V and pneumococcal conjugate vaccines at varying schedules.
 Biological: Meningococcal ACWY Conjugate Vaccine
MenACWY was administered at 2, 4, 6, 12 or 13, 15, 16 or 17, and 18 months.
Other Name: Menveo
Biological: DTaP-IPV-HBV
DTaP-IPV-HBV was administered at 2, 4, 6, and 16 months.
Other Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined; Pediarix
Biological: Hib
Hib was administered at 2, 4, 6, and 16 months.
Other Name: ActHIB; Haemophilus influenzae type b Conjugate Vaccine
Biological: rotavirus
Rotavirus was administered at 2, 4, and 6 months
Biological: Pneumococcal 7-valent Conjugate Vaccine
Pneumococcal 7-valent Conjugate Vaccine was administered at 2, 4, 6, 12 or 13 months.
Other Name: Prevnar
Biological: HAV
Hepatitis A Vaccine, Inactivated was administered at 12 or 13 months.
Other Name: Havrix; Hepatitis A Vaccine, Inactivated
Biological: MMR
MMR was administered at 12 or 13 months.
Other Name: Measles, Mumps and Rubella vaccine
Experimental: US3 (MenACWY-CRM + Infant Vaccines)
Along with Meningococcal ACWY Conjugate Vaccine infants received pediatric vaccines DTaP-IPV-HBV, Hib, rotavirus, HAV, MMR-V and pneumococcal conjugate vaccines at varying schedules.
 Biological: Meningococcal ACWY Conjugate Vaccine
MenACWY was administered at 2, 4, 6, 12 or 13, 15, 16 or 17, and 18 months.
Other Name: Menveo
Biological: DTaP-IPV-HBV
DTaP-IPV-HBV was administered at 2, 4, 6, and 16 months.
Other Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined; Pediarix
Biological: Hib
Hib was administered at 2, 4, 6, and 16 months.
Other Name: ActHIB; Haemophilus influenzae type b Conjugate Vaccine
Biological: rotavirus
Rotavirus was administered at 2, 4, and 6 months
Biological: Pneumococcal 7-valent Conjugate Vaccine
Pneumococcal 7-valent Conjugate Vaccine was administered at 2, 4, 6, 12 or 13 months.
Other Name: Prevnar
Biological: HAV
Hepatitis A Vaccine, Inactivated was administered at 12 or 13 months.
Other Name: Havrix; Hepatitis A Vaccine, Inactivated
Biological: MMR
MMR was administered at 12 or 13 months.
Other Name: Measles, Mumps and Rubella vaccine
Experimental: US4A (Infant Vaccines Only)
Along with Meningococcal ACWY Conjugate Vaccine infants received pediatric vaccines DTaP-IPV-HBV, Hib, rotavirus, HAV, MMR-V and pneumococcal conjugate vaccines at varying schedules.
 Biological: Meningococcal ACWY Conjugate Vaccine
MenACWY was administered at 2, 4, 6, 12 or 13, 15, 16 or 17, and 18 months.
Other Name: Menveo
Biological: DTaP-IPV-HBV
DTaP-IPV-HBV was administered at 2, 4, 6, and 16 months.
Other Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined; Pediarix
Biological: Hib
Hib was administered at 2, 4, 6, and 16 months.
Other Name: ActHIB; Haemophilus influenzae type b Conjugate Vaccine
Biological: rotavirus
Rotavirus was administered at 2, 4, and 6 months
Biological: HAV
Hepatitis A Vaccine, Inactivated was administered at 12 or 13 months.
Other Name: Havrix; Hepatitis A Vaccine, Inactivated
Biological: MMR
MMR was administered at 12 or 13 months.
Other Name: Measles, Mumps and Rubella vaccine
Experimental: US4B (Infant Vaccines Only)
Along with Meningococcal ACWY Conjugate Vaccine infants received pediatric vaccines DTaP-IPV-HBV, Hib, rotavirus, HAV, MMR-V and pneumococcal conjugate vaccines at varying schedules.
 Biological: Meningococcal ACWY Conjugate Vaccine
MenACWY was administered at 2, 4, 6, 12 or 13, 15, 16 or 17, and 18 months.
Other Name: Menveo
Biological: DTaP-IPV-HBV
DTaP-IPV-HBV was administered at 2, 4, 6, and 16 months.
Other Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined; Pediarix
Biological: Hib
Hib was administered at 2, 4, 6, and 16 months.
Other Name: ActHIB; Haemophilus influenzae type b Conjugate Vaccine
Biological: rotavirus
Rotavirus was administered at 2, 4, and 6 months
Biological: Pneumococcal 7-valent Conjugate Vaccine
Pneumococcal 7-valent Conjugate Vaccine was administered at 2, 4, 6, 12 or 13 months.
Other Name: Prevnar
Biological: HAV
Hepatitis A Vaccine, Inactivated was administered at 12 or 13 months.
Other Name: Havrix; Hepatitis A Vaccine, Inactivated
Biological: MMR
MMR was administered at 12 or 13 months.
Other Name: Measles, Mumps and Rubella vaccine
Experimental: US4C (Infant Vaccines Only)
Along with Meningococcal ACWY Conjugate Vaccine infants received pediatric vaccines DTaP-IPV-HBV, Hib, rotavirus, HAV, MMR-V and pneumococcal conjugate vaccines at varying schedules.
 Biological: Meningococcal ACWY Conjugate Vaccine
MenACWY was administered at 2, 4, 6, 12 or 13, 15, 16 or 17, and 18 months.
Other Name: Menveo
Biological: DTaP-IPV-HBV
DTaP-IPV-HBV was administered at 2, 4, 6, and 16 months.
Other Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined; Pediarix
Biological: Hib
Hib was administered at 2, 4, 6, and 16 months.
Other Name: ActHIB; Haemophilus influenzae type b Conjugate Vaccine
Biological: rotavirus
Rotavirus was administered at 2, 4, and 6 months
Biological: Pneumococcal 7-valent Conjugate Vaccine
Pneumococcal 7-valent Conjugate Vaccine was administered at 2, 4, 6, 12 or 13 months.
Other Name: Prevnar
Biological: HAV
Hepatitis A Vaccine, Inactivated was administered at 12 or 13 months.
Other Name: Havrix; Hepatitis A Vaccine, Inactivated
Biological: MMR
MMR was administered at 12 or 13 months.
Other Name: Measles, Mumps and Rubella vaccine
Experimental: LA1A (MenACWY-CRM + Infant Vaccines)
Along with Meningococcal ACWY Conjugate Vaccine infants received pediatric vaccines DTaP-IPV-HBV, Hib, rotavirus, HAV, MMR-V and pneumococcal conjugate vaccines at varying schedules.
 Biological: Meningococcal ACWY Conjugate Vaccine
MenACWY was administered at 2, 4, 6, 12 or 13, 15, 16 or 17, and 18 months.
Other Name: Menveo
Biological: DTaP-IPV-HBV
DTaP-IPV-HBV was administered at 2, 4, 6, and 16 months.
Other Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined; Pediarix
Biological: Hib
Hib was administered at 2, 4, 6, and 16 months.
Other Name: ActHIB; Haemophilus influenzae type b Conjugate Vaccine
Biological: rotavirus
Rotavirus was administered at 2, 4, and 6 months
Biological: Pneumococcal 7-valent Conjugate Vaccine
Pneumococcal 7-valent Conjugate Vaccine was administered at 2, 4, 6, 12 or 13 months.
Other Name: Prevnar
Biological: HAV
Hepatitis A Vaccine, Inactivated was administered at 12 or 13 months.
Other Name: Havrix; Hepatitis A Vaccine, Inactivated
Biological: MMR
MMR was administered at 12 or 13 months.
Other Name: Measles, Mumps and Rubella vaccine
Experimental: LA1B (MenACWY-CRM + Infant Vaccines)
Along with Meningococcal ACWY Conjugate Vaccine infants received pediatric vaccines DTaP-IPV-HBV, Hib, rotavirus, HAV, MMR-V and pneumococcal conjugate vaccines at varying schedules.
 Biological: Meningococcal ACWY Conjugate Vaccine
MenACWY was administered at 2, 4, 6, 12 or 13, 15, 16 or 17, and 18 months.
Other Name: Menveo
Biological: DTaP-IPV-HBV
DTaP-IPV-HBV was administered at 2, 4, 6, and 16 months.
Other Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined; Pediarix
Biological: Hib
Hib was administered at 2, 4, 6, and 16 months.
Other Name: ActHIB; Haemophilus influenzae type b Conjugate Vaccine
Biological: rotavirus
Rotavirus was administered at 2, 4, and 6 months
Biological: Pneumococcal 7-valent Conjugate Vaccine
Pneumococcal 7-valent Conjugate Vaccine was administered at 2, 4, 6, 12 or 13 months.
Other Name: Prevnar
Biological: HAV
Hepatitis A Vaccine, Inactivated was administered at 12 or 13 months.
Other Name: Havrix; Hepatitis A Vaccine, Inactivated
Biological: MMR
MMR was administered at 12 or 13 months.
Other Name: Measles, Mumps and Rubella vaccine
Experimental: LA2 (Infant Vaccines Only)
Along with Meningococcal ACWY Conjugate Vaccine infants received pediatric vaccines DTaP-IPV-HBV, Hib, rotavirus, HAV, MMR-V and pneumococcal conjugate vaccines at varying schedules.
 Biological: Meningococcal ACWY Conjugate Vaccine
MenACWY was administered at 2, 4, 6, 12 or 13, 15, 16 or 17, and 18 months.
Other Name: Menveo
Biological: DTaP-IPV-HBV
DTaP-IPV-HBV was administered at 2, 4, 6, and 16 months.
Other Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined; Pediarix
Biological: Hib
Hib was administered at 2, 4, 6, and 16 months.
Other Name: ActHIB; Haemophilus influenzae type b Conjugate Vaccine
Biological: rotavirus
Rotavirus was administered at 2, 4, and 6 months
Biological: Pneumococcal 7-valent Conjugate Vaccine
Pneumococcal 7-valent Conjugate Vaccine was administered at 2, 4, 6, 12 or 13 months.
Other Name: Prevnar
Biological: HAV
Hepatitis A Vaccine, Inactivated was administered at 12 or 13 months.
Other Name: Havrix; Hepatitis A Vaccine, Inactivated
Biological: MMR
MMR was administered at 12 or 13 months.
Other Name: Measles, Mumps and Rubella vaccine
Experimental: LA3A (MenACWY-CRM + Infant Vaccines)
Along with Meningococcal ACWY Conjugate Vaccine infants received pediatric vaccines DTaP-IPV-HBV, Hib, rotavirus, HAV, MMR-V and pneumococcal conjugate vaccines at varying schedules.
 Biological: Meningococcal ACWY Conjugate Vaccine
MenACWY was administered at 2, 4, 6, 12 or 13, 15, 16 or 17, and 18 months.
Other Name: Menveo
Biological: DTaP-IPV-HBV
DTaP-IPV-HBV was administered at 2, 4, 6, and 16 months.
Other Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined; Pediarix
Biological: Hib
Hib was administered at 2, 4, 6, and 16 months.
Other Name: ActHIB; Haemophilus influenzae type b Conjugate Vaccine
Biological: rotavirus
Rotavirus was administered at 2, 4, and 6 months
Biological: Pneumococcal 7-valent Conjugate Vaccine
Pneumococcal 7-valent Conjugate Vaccine was administered at 2, 4, 6, 12 or 13 months.
Other Name: Prevnar
Biological: HAV
Hepatitis A Vaccine, Inactivated was administered at 12 or 13 months.
Other Name: Havrix; Hepatitis A Vaccine, Inactivated
Biological: MMR
MMR was administered at 12 or 13 months.
Other Name: Measles, Mumps and Rubella vaccine
Experimental: LA3B (MenACWY-CRM + Infant Vaccines)
Along with Meningococcal ACWY Conjugate Vaccine infants received pediatric vaccines DTaP-IPV-HBV, Hib, rotavirus, HAV, MMR-V and pneumococcal conjugate vaccines at varying schedules.
 Biological: Meningococcal ACWY Conjugate Vaccine
MenACWY was administered at 2, 4, 6, 12 or 13, 15, 16 or 17, and 18 months.
Other Name: Menveo
Biological: DTaP-IPV-HBV
DTaP-IPV-HBV was administered at 2, 4, 6, and 16 months.
Other Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined; Pediarix
Biological: Hib
Hib was administered at 2, 4, 6, and 16 months.
Other Name: ActHIB; Haemophilus influenzae type b Conjugate Vaccine
Biological: rotavirus
Rotavirus was administered at 2, 4, and 6 months
Biological: Pneumococcal 7-valent Conjugate Vaccine
Pneumococcal 7-valent Conjugate Vaccine was administered at 2, 4, 6, 12 or 13 months.
Other Name: Prevnar
Biological: HAV
Hepatitis A Vaccine, Inactivated was administered at 12 or 13 months.
Other Name: Havrix; Hepatitis A Vaccine, Inactivated
Biological: MMR
MMR was administered at 12 or 13 months.
Other Name: Measles, Mumps and Rubella vaccine
Experimental: LA4 (Infant Vaccines Only)
Along with Meningococcal ACWY Conjugate Vaccine infants received pediatric vaccines DTaP-IPV-HBV, Hib, rotavirus, HAV, MMR-V and pneumococcal conjugate vaccines at varying schedules.
 Biological: Meningococcal ACWY Conjugate Vaccine
MenACWY was administered at 2, 4, 6, 12 or 13, 15, 16 or 17, and 18 months.
Other Name: Menveo
Biological: DTaP-IPV-HBV
DTaP-IPV-HBV was administered at 2, 4, 6, and 16 months.
Other Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined; Pediarix
Biological: Hib
Hib was administered at 2, 4, 6, and 16 months.
Other Name: ActHIB; Haemophilus influenzae type b Conjugate Vaccine
Biological: rotavirus
Rotavirus was administered at 2, 4, and 6 months
Biological: Pneumococcal 7-valent Conjugate Vaccine
Pneumococcal 7-valent Conjugate Vaccine was administered at 2, 4, 6, 12 or 13 months.
Other Name: Prevnar
Biological: HAV
Hepatitis A Vaccine, Inactivated was administered at 12 or 13 months.
Other Name: Havrix; Hepatitis A Vaccine, Inactivated
Biological: MMR
MMR was administered at 12 or 13 months.
Other Name: Measles, Mumps and Rubella vaccine
Experimental: LA5 (MenACWY-CRM + Infant Vaccines)
Along with Meningococcal ACWY Conjugate Vaccine infants received pediatric vaccines DTaP-IPV-HBV, Hib, rotavirus, HAV, MMR-V and pneumococcal conjugate vaccines at varying schedules.
 Biological: Meningococcal ACWY Conjugate Vaccine
MenACWY was administered at 2, 4, 6, 12 or 13, 15, 16 or 17, and 18 months.
Other Name: Menveo
Biological: DTaP-IPV-HBV
DTaP-IPV-HBV was administered at 2, 4, 6, and 16 months.
Other Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined; Pediarix
Biological: Hib
Hib was administered at 2, 4, 6, and 16 months.
Other Name: ActHIB; Haemophilus influenzae type b Conjugate Vaccine
Biological: rotavirus
Rotavirus was administered at 2, 4, and 6 months
Biological: Pneumococcal 7-valent Conjugate Vaccine
Pneumococcal 7-valent Conjugate Vaccine was administered at 2, 4, 6, 12 or 13 months.
Other Name: Prevnar
Biological: HAV
Hepatitis A Vaccine, Inactivated was administered at 12 or 13 months.
Other Name: Havrix; Hepatitis A Vaccine, Inactivated
Biological: MMR
MMR was administered at 12 or 13 months.
Other Name: Measles, Mumps and Rubella vaccine
Experimental: LA6A (Infant Vaccines Only)
Along with Meningococcal ACWY Conjugate Vaccine infants received pediatric vaccines DTaP-IPV-HBV, Hib, rotavirus, HAV, MMR-V and pneumococcal conjugate vaccines at varying schedules.
 Biological: Meningococcal ACWY Conjugate Vaccine
MenACWY was administered at 2, 4, 6, 12 or 13, 15, 16 or 17, and 18 months.
Other Name: Menveo
Biological: DTaP-IPV-HBV
DTaP-IPV-HBV was administered at 2, 4, 6, and 16 months.
Other Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined; Pediarix
Biological: Hib
Hib was administered at 2, 4, 6, and 16 months.
Other Name: ActHIB; Haemophilus influenzae type b Conjugate Vaccine
Biological: rotavirus
Rotavirus was administered at 2, 4, and 6 months
Biological: Pneumococcal 7-valent Conjugate Vaccine
Pneumococcal 7-valent Conjugate Vaccine was administered at 2, 4, 6, 12 or 13 months.
Other Name: Prevnar
Biological: HAV
Hepatitis A Vaccine, Inactivated was administered at 12 or 13 months.
Other Name: Havrix; Hepatitis A Vaccine, Inactivated
Biological: MMR
MMR was administered at 12 or 13 months.
Other Name: Measles, Mumps and Rubella vaccine
Experimental: LA6B (Infant Vaccines Only)
Along with Meningococcal ACWY Conjugate Vaccine infants received pediatric vaccines DTaP-IPV-HBV, Hib, rotavirus, HAV, MMR-V and pneumococcal conjugate vaccines at varying schedules.
 Biological: Meningococcal ACWY Conjugate Vaccine
MenACWY was administered at 2, 4, 6, 12 or 13, 15, 16 or 17, and 18 months.
Other Name: Menveo
Biological: DTaP-IPV-HBV
DTaP-IPV-HBV was administered at 2, 4, 6, and 16 months.
Other Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined; Pediarix
Biological: Hib
Hib was administered at 2, 4, 6, and 16 months.
Other Name: ActHIB; Haemophilus influenzae type b Conjugate Vaccine
Biological: rotavirus
Rotavirus was administered at 2, 4, and 6 months
Biological: Pneumococcal 7-valent Conjugate Vaccine
Pneumococcal 7-valent Conjugate Vaccine was administered at 2, 4, 6, 12 or 13 months.
Other Name: Prevnar
Biological: HAV
Hepatitis A Vaccine, Inactivated was administered at 12 or 13 months.
Other Name: Havrix; Hepatitis A Vaccine, Inactivated
Biological: MMR
MMR was administered at 12 or 13 months.
Other Name: Measles, Mumps and Rubella vaccine
Experimental: LA6C (Infant Vaccines Only)
Along with Meningococcal ACWY Conjugate Vaccine infants received pediatric vaccines DTaP-IPV-HBV, Hib, rotavirus, HAV, MMR-V and pneumococcal conjugate vaccines at varying schedules.
 Biological: Meningococcal ACWY Conjugate Vaccine
MenACWY was administered at 2, 4, 6, 12 or 13, 15, 16 or 17, and 18 months.
Other Name: Menveo
Biological: DTaP-IPV-HBV
DTaP-IPV-HBV was administered at 2, 4, 6, and 16 months.
Other Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined; Pediarix
Biological: Hib
Hib was administered at 2, 4, 6, and 16 months.
Other Name: ActHIB; Haemophilus influenzae type b Conjugate Vaccine
Biological: rotavirus
Rotavirus was administered at 2, 4, and 6 months
Biological: Pneumococcal 7-valent Conjugate Vaccine
Pneumococcal 7-valent Conjugate Vaccine was administered at 2, 4, 6, 12 or 13 months.
Other Name: Prevnar
Biological: HAV
Hepatitis A Vaccine, Inactivated was administered at 12 or 13 months.
Other Name: Havrix; Hepatitis A Vaccine, Inactivated

  Eligibility

Ages Eligible for Study:   2 Months to 2 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00474526

  Show 63 Study Locations
Sponsors and Collaborators
Novartis Vaccines
Investigators
Study Chair: Novartis - Vaccines Novartis Vaccines & Diagnostics
  More Information

Publications:

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00474526     History of Changes
Other Study ID Numbers: V59P14
Study First Received: May 16, 2007
Last Updated: October 17, 2012
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Colombia: INVIMA

Keywords provided by Novartis:
Meningococcal
meningitis
vaccine
 infants
Meningococcal meningitis
Meningococcal disease

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

ClinicalTrials.gov processed this record on May 22, 2013