A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Infants
- Conditions
- Meningitis, Meningococcal
- Registration Number
- NCT00474526
- Lead Sponsor
- Novartis Vaccines
- Brief Summary
This study will evaluate the safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine when administered with routine infant vaccinations to healthy infants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4545
- Healthy term 2-month-old infants for whom a parent/legal representative has given written informed consent.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Percentage of Subjects With hSBA Titer >=1:8 - US Subjects 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 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.
- Secondary Outcome Measures
Name Time Method Percentage of Subjects (95% CI) With hSBA ≥1:4 at 1 Month After Toddler MenACWY Vaccination - LA Subjects 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 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.
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series 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 7 days post-vaccination Solicited local and systemic reactions reported post third vaccination was compared in subjects receiving MenACWY versus Hib Vaccines.
Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age 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 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 7 days post vaccination Solicited local and systemic reactions post second vaccination of toddler series at 15 months of age.
Geometric Mean hSBA Titers Post-infant Series - US Subjects 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 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 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 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 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 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 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 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 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 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.
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series 7 days post-vaccination Solicited local and systemic reactions reported post first vaccination was compared in subjects receiving MenACWY versus Hib Vaccines.
Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 Months of Age- US Subject 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 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 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 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 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 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 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 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 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 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 With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - LA Subjects 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 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 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 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 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 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 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 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 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 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.
Trial Locations
- Locations (61)
Growing Up Pediatrics
🇺🇸Birmingham, Alabama, United States
Alabama Clinical Therapeutics, LLC
🇺🇸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
Kaiser Permanente Santa Clara
🇺🇸Santa Clara, California, United States
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