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: February 24, 2014
Last verified: February 2014
  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-V
Biological: DTaP
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:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Percentage of Subjects With hSBA Titer >=1:8 - US Subjects [ Time Frame: 13 months of age (one month post-toddler vaccination) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series [ Time Frame: 7 days after vaccination ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ 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.

  • 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ 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.

  • 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ 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.

  • 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) ] [ Designated as safety issue: No ]
    Immunogenicity as measured by Serum bactericidal activity using human complement (hSBA) GMTs, 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)

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
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)
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

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)
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

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)
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

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)
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

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: HAV
Other Name: Havrix® (Hepatitis A Vaccine, Inactivated)
Biological: MMR-V
Other Name: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine)
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

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)
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

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)
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

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)
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

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)
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

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)
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

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: 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

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: 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

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: 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

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)
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

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)
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

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)
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

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)

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Results First Received: May 27, 2013
Last Updated: February 24, 2014
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 August 18, 2014