This study will evaluate the safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine when administered with routine infant vaccinations to healthy infants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
4,545
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
Time frame: 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.
Time frame: 13 months of age (one month post-toddler vaccination)
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series
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.
Time frame: 7 days after vaccination
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series
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.
Time frame: 7 days after vaccination
Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series
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.
Time frame: 7 days after vaccination
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Growing Up Pediatrics
Bessemer, Alabama, United States
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, United States
Growing Up Pediatrics
Birmingham, Alabama, United States
Premier Health Research Center, LLC
Downey, California, United States
Kaiser Permanente Oakland
Oakland, California, United States
Kaiser Permanente Med Group - Vaccine Study Ctr
Oakland, California, United States
Center for Clinical Trials, LLC
Paramount, California, United States
Kaiser Permanente Pleasanton
Pleasanton, California, United States
Kaiser Permanente Richmond
Richmond, California, United States
Kaiser Permanente San Francisco
San Francisco, California, United States
...and 53 more locations
Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age
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.
Time frame: 7 days after vaccination
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series
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.
Time frame: 7 days post vaccination
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series
Solicited local and systemic reactions post second vaccination of toddler series at 15 months of age.
Time frame: 7 days post vaccination
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series
Solicited local and systemic reactions reported post first vaccination was compared in subjects receiving MenACWY versus Hib Vaccines.
Time frame: 7 days post-vaccination
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series
Solicited local and systemic reactions reported post second vaccination was compared in subjects receiving MenACWY versus Hib Vaccines.
Time frame: 7 days post-vaccination
Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series
Solicited local and systemic reactions reported post third vaccination was compared in subjects receiving MenACWY versus Hib Vaccines.
Time frame: 7 days post-vaccination
Geometric Mean hSBA Titers Post-infant Series - US Subjects
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.
Time frame: 7 months of age (one month post-infant series)
Geometric Mean hSBA Titers Post-infant Series - LA Subjects
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.
Time frame: 7 months of age (one month post-infant series)
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 three doses of MenACWY at 2, 4, and 6 months of age.
Time frame: 7 months of age (one month post-infant series)
Percentage of Subjects With hSBA Titer >=1:4 - US Subjects
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.
Time frame: 7 months of age (one month post-infant series)
Percentage of Subjects With hSBA Titer >=1:8 - LA Subjects
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) .
Time frame: 7 months of age (one month post-infant series)
Percentage of Subjects With hSBA Titer >=1:4 - LA Subjects
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) .
Time frame: 7 months of age (one month post-infant series)
Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects
Immunogenicity as measured by antibody GMCs / GMTs directed against DTaP, HBV, Hib, pneumococcal and polio antigens.
Time frame: 7 months of age (one month post-infant series)
Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects
Immunogenicity as measured by percentage of subjects with predefined seroprotective antibody titers against DTaP, HBV, Hib, pneumococcal and polio antigens.
Time frame: 7 months of age (one month post-infant series)
Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects
Immunogenicity as measured by antibody GMCs / GMTs directed against DTaP, HBV, Hib, pneumococcal and polio antigens.
Time frame: 7 months of age (one month post-infant series)
Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects
Immunogenicity as measured by percentage of subjects with predefined seroprotective antibody titers against DTaP, HBV, Hib, pneumococcal and polio antigens.
Time frame: 7 months of age (one month post-infant series)
Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 Months of Age- US Subject
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.
Time frame: 12 Months of Age (one month pre-toddler vaccination)
Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 Months of Age- US Subject
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.
Time frame: 12 Months of Age (one month pre-toddler vaccination)
Persistence Antibodies Geometric Mean Titers - US Subject
Geometric Mean hSBA Titers directed against N. meningitides serogroups A, C, W and Y was measured at 12 Months of Age.
Time frame: 12 Months of Age (one month pre-toddler vaccination)
Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 or 16 Months of Age- LA Subject
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.
Time frame: 12 or 16 Months of Age (one month pre-toddler vaccination)
Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 or 16 Months of Age- LA Subject
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.
Time frame: 12 or 16 Months of Age (one month pre-toddler vaccination)
Persistence Antibodies Geometric Mean Titers - LA Subjects
Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y was measured at 12 or 16 Months of Age.
Time frame: 12 or 16 Months of Age (one month pre-toddler vaccination)
Percentage of Subjects (95% CI) With hSBA ≥ 1:4 at 1 Month After Toddler MenACWY Vaccination - US Subjects
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.
Time frame: 13 months of age (one month post-toddler vaccination)
Percentage of Subjects (95% CI) With hSBA ≥ 1:8 at 1 Month After Toddler MenACWY Vaccination - US Subjects
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.
Time frame: 13 months of age (one month post-toddler vaccination)
Percentage of Subjects (95% CI) With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - US Subjects
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.
Time frame: 13 months of age (one month post-toddler vaccination)
Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - 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.
Time frame: 13 months of age (one month post-toddler vaccination)
Percentage of Subjects (95% CI) With hSBA ≥1:4 at 1 Month After Toddler MenACWY Vaccination - LA Subjects
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.
Time frame: 13 or 17 Months of Age (one month post-toddler vaccination)
Percentage of Subjects (95% CI) With hSBA ≥1:8 at 1 Month After Toddler MenACWY Vaccination - LA Subjects
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.
Time frame: 13 or 17 Months of Age (one month post-toddler vaccination)
Percentage of Subjects With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - LA Subjects
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.
Time frame: 13 or 17 Months of Age (one month post-toddler vaccination)
Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - LA Subjects
Immunogenicity as measured by Serum bactericidal activity using human complement (hSBA) GMTs, directed against N. meningitidis serogroups A, C, W and Y.
Time frame: 13 or 17 Months of Age (one month post-toddler vaccination)
Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - US Subjects
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.
Time frame: 13 months of age (one month post-toddler vaccination)
Percentage of Subjects With Pneumococcal Antibody GMCs ≥1.0 μg/mL at 1 Month After Toddler Vaccination - US Subjects
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.
Time frame: 13 months of age (one month post-toddler vaccination)
Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - LA Subjects
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.
Time frame: 13 months of age (one month post-toddler vaccination)
Percentage of Subjects With Pneumococcal Antibody Concentration ≥1.0 μg/mL at 1 Month After Toddler Vaccination - LA Subjects
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
Time frame: 13 months of age (one month post-toddler vaccination)
Geometric Mean Concentrations or Titers of DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects
Immunogenicity as measured by antibody GMCs/GMTs, directed against DTaP and Hib Antigens
Time frame: 17 months of age (one month post-toddler vaccination)
Seroresponse Rates to DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects
Immunogenicity as measured by Percentage of Subjects with predefined seroprotective antibody titers against DTaP and Hib Antigens
Time frame: 17 months of age (one month post-toddler vaccination)
Percentage of Subjects With hSBA ≥1:8 at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects
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.
Time frame: 12 or 15 months of age (one month post 1st or 2nd toddler vaccination)
Geometric Mean hSBA Titers at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects
Immunogenicity as measured by Serum bactericidal activity using human complement (hSBA) GMTs, directed against N. meningitidis serogroups A, C, W and Y.
Time frame: 12 or 15 months of age (one month post 1st or 2nd toddler vaccination)