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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:
ClinicalTrials.gov Identifier:
NCT00474526
First Posted: May 17, 2007
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
May 16, 2007
May 17, 2007
May 27, 2013
March 24, 2014
October 12, 2017
March 2007
September 2008   (Final data collection date for primary outcome measure)
  • 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
  • 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.
Immunogenicity of routine infant vaccines when given concomitantly with MenACWY in a primary vaccine series and as a booster at 12 months of age as measured by serum bactericidal antibodies.
Complete list of historical versions of study NCT00474526 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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) .
  • 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) .
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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
  • 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
  • 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.
  • 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.
  • Immunogenicity of Novertis MenACWY Conjugate Vaccine when given in an alternative primary or boost schedule
  • Safety and tolerability of Novartis MenACWY when given with concomitant vaccines during routine primary series or booster doses
Not Provided
Not Provided
 
A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Infants
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Meningitis, Meningococcal
  • Biological: Meningococcal ACWY Conjugate Vaccine
    Other Name: Menveo
  • Biological: DTaP-IPV-HBV
    Other Name: Pediarix® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined
  • Biological: Hib
    Other Name: ActHIB® (Haemophilus influenzae type b Conjugate Vaccine)
  • Biological: Rotavirus
    Other Name: RotaTeq® Rotavirus Vaccine, Live, Oral, Pentavalent
  • Biological: Pneumococcal 7-valent Conjugate Vaccine
    Other Name: Prevnar®
  • Biological: HAV
    Other Name: Havrix® (Hepatitis A Vaccine, Inactivated)
  • Biological: MMR-V
    Other Name: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine)
  • Biological: DTaP
    Other Name: Infanrix® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed)
  • 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

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

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

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

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

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

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

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

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

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

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

    Interventions:
    • 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
  • 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

    Interventions:
    • 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
  • 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

    Interventions:
    • 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
  • 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

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

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

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

    Interventions:
    • Biological: Meningococcal ACWY Conjugate Vaccine
    • Biological: DTaP-IPV-HBV
    • Biological: Hib
    • Biological: Rotavirus
    • Biological: Pneumococcal 7-valent Conjugate Vaccine
    • Biological: HAV
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. Erratum in: Pediatr Infect Dis J. 2012 Oct;31(10):1105.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4545
November 2009
September 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
2 Months to 2 Months   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Argentina,   Colombia,   United States
 
 
NCT00474526
V59P14
Not Provided
Not Provided
Not Provided
Novartis ( Novartis Vaccines )
Novartis Vaccines
Not Provided
Study Chair: Novartis - Vaccines Novartis Vaccines & Diagnostics
Novartis
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP