Phase 3
Completed N=4,545
A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Infants
Meningitis, Meningococcal
Source: ClinicalTrials.gov NCT00474526 ↗
Enrolled (actual)
4,545
Serious AEs
7.9%
Results posted
Mar 2014
Primary outcomePrimary: Percentage of Subjects With hSBA Titer >=1:8 - US Subjects — 94; 72; 98; 90 Percentages of subjects
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With hSBA Titer >=1:8 - US Subjects |
2; 3; 67; 1; 7; 5 | — |
| PRIMARY Geometric Mean hSBA Titers - US Subjects |
2.51; 2.14; 77; 17; 7.72; 2.26 | — |
| SECONDARY Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series |
93; 77; 628; 338; 0; 6 | — |
| SECONDARY Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series |
108; 95; 675; 356; 0; 2 | — |
| SECONDARY Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series |
126; 95; 549; 311; 0; 2 | — |
| SECONDARY Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age |
11; 16; 81; 18; 70; 49 | — |
| SECONDARY Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series |
7; 81; 18; 9; 28; 36 | — |
| SECONDARY Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series |
14; 6; 143; 28; 0; 1 | — |
| SECONDARY Geometric Mean hSBA Titers Post-infant Series - US Subjects |
2.11; 2.1; 13; 2.03; 2.48; 2.17 | — |
| SECONDARY Geometric Mean hSBA Titers Post-infant Series - LA Subjects |
2.09; 2.03; 31; 43; 2.32; 2.34 | — |
| SECONDARY Percentage of Subjects With hSBA Titer >=1:8 - US Subjects |
2; 3; 67; 1; 7; 5 | — |
| SECONDARY Percentage of Subjects With hSBA Titer >=1:4 - US Subjects |
2; 3; 71; 1; 10; 5 | — |
| SECONDARY Percentage of Subjects With hSBA Titer >=1:8 - LA Subjects |
1; 0; 74; 89; 4; 4 | — |
| SECONDARY Percentage of Subjects With hSBA Titer >=1:4 - LA Subjects |
2; 1; 78; 91; 10; 10 | — |
| SECONDARY Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects |
2.52; 2.88; 2.5; 2.31; 54; 54 | — |
| SECONDARY Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects |
100; 100; 100; 100; 87; 86 | — |
| SECONDARY Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects |
1.8; 1.54; 1.45; 1.77; 2.41; 2.19 | — |
| SECONDARY Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects |
99; 98; 99; 99; 100; 100 | — |
| SECONDARY Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 Months of Age- US Subject |
12; 3; 53; 8; 80; 4 | — |
| SECONDARY Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 Months of Age- US Subject |
10; 1; 50; 7; 71; 4 | — |
| SECONDARY Persistence Antibodies Geometric Mean Titers - US Subject |
2.51; 2.14; 7.72; 2.26; 14; 2.21 | — |
| SECONDARY Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 or 16 Months of Age- LA Subject |
29; 1; 18; 1; 62; 4 | — |
| SECONDARY Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 or 16 Months of Age- LA Subject |
25; 0; 15; 0; 57; 4 | — |
| SECONDARY Persistence Antibodies Geometric Mean Titers - LA Subjects |
4.26; 2.02; 2.96; 2.02; 12; 2.18 | — |
| SECONDARY Percentage of Subjects (95% CI) With hSBA ≥ 1:4 at 1 Month After Toddler MenACWY Vaccination - US Subjects |
12; 3; 94; 78; 53; 8 | — |
| SECONDARY Percentage of Subjects (95% CI) With hSBA ≥ 1:8 at 1 Month After Toddler MenACWY Vaccination - US Subjects |
10; 1; 94; 72; 50; 7 | — |
| SECONDARY Percentage of Subjects (95% CI) With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - US Subjects |
5; 1; 90; 55; 35; 0 | — |
| SECONDARY Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - US Subjects |
2.51; 2.14; 77; 17; 7.72; 2.26 | — |
| SECONDARY Percentage of Subjects (95% CI) With hSBA ≥1:4 at 1 Month After Toddler MenACWY Vaccination - LA Subjects |
28; 18; 94; 95; 61; 30 | — |
| SECONDARY Percentage of Subjects (95% CI) With hSBA ≥1:8 at 1 Month After Toddler MenACWY Vaccination - LA Subjects |
23; 13; 94; 95; 57; 22 | — |
| SECONDARY Percentage of Subjects With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - LA Subjects |
16; 9; 93; 94; 47; 18 | — |
| SECONDARY Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - LA Subjects |
3.83; 2.95; 112; 146; 11; 3.83 | — |
| SECONDARY Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - US Subjects |
2.9; 3.24; 6.82; 8.58; 2.8; 3.13 | — |
| SECONDARY Percentage of Subjects With Pneumococcal Antibody GMCs ≥1.0 μg/mL at 1 Month After Toddler Vaccination - US Subjects |
91; 90; 84; 100; 96; 99 | — |
| SECONDARY Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - LA Subjects |
3.16; 4.02; 4.52; 5.61; 2.79; 3.77 | — |
| SECONDARY Percentage of Subjects With Pneumococcal Antibody Concentration ≥1.0 μg/mL at 1 Month After Toddler Vaccination - LA Subjects |
93; 95; 86; 89; 92; 95 | — |
| SECONDARY Geometric Mean Concentrations or Titers of DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects |
5.4; 5.16; 6.17; 6.58; 68; 62 | — |
| SECONDARY Seroresponse Rates to DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects |
98; 98; 98; 98; 89; 84 | — |
| SECONDARY Percentage of Subjects With hSBA ≥1:8 at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects |
0; 0; 74; 97; 4; 1 | — |
| SECONDARY Geometric Mean hSBA Titers at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects |
2.02; 2.02; 25; 128; 2.18; 2.05 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00474526). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.