Phase 3
Completed N=662
Safety and Immunogenicity Evaluation After One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Infants and Toddlers
Source: ClinicalTrials.gov NCT00667602 ↗Enrolled (actual)
662
Serious AEs
7.8%
Results posted
Nov 2013
Primary outcomePrimary: Percentages of Subjects With Serum Bactericidal Titer ≥ 1:8 Against N.Meningitidis Serogroup C — 83; 92 Percentages of subjects
Summary
The primary immunogenicity objective is to assess and compare the immunogenicity of one dose of MenACWY to one dose of Menjugate given to healthy toddlers at 12 months of age as measured by the percentage of subjects with serum bactericidal titers directed against N. meningitidis serogroup C ≥ 1:8 obtained in the serum bactericidal assay using human complement (hSBA).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentages of Subjects With Serum Bactericidal Titer ≥ 1:8 Against N.Meningitidis Serogroup C |
83; 92 | — |
| SECONDARY Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:4 Against N.Meningitidis Serogroup C |
90; 97 | — |
| SECONDARY Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, Y |
21; 0; 93; 0; 78; 6 | — |
| SECONDARY Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, W, Y |
1; 49; 3; 61; 3; 50 | — |
| SECONDARY Human Serum Bactericidal Activity Geometric Mean Titers After One Dose of MenACWY-CRM197 and MenC Against N.Meningitidis Serogroup C |
2.11; 2.29; 22; 31 | — |
| SECONDARY Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, W, Y |
1.99; 10; 2.12; 14; 1.92; 7.05 | — |
| SECONDARY Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W, Y |
3.4; 2; 75; 2.22; 23; 2.29 | — |
| SECONDARY Percentages of Subjects With Seroresponse Rates After One Dose of DTPa-IPV-HepB-Hib (Concomitant Vaccine) |
100; 100; 100; 99; 98; 98 | — |
| SECONDARY Percentages of Subjects With Seroresponse Rates After One Dose of PCV7 (Concomitant Vaccine) |
83; 82; 87; 92; 91; 97 | — |
| SECONDARY Persistence of Immune Response Measured as Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroup C |
100; 86; 92; 71; 64; 54 | — |
| SECONDARY Persistence of Immune Response Measured as Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 ,and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, W, Y |
88; 42; 31; 7; 100; 50 | — |
| SECONDARY Persistence of Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup C |
241; 36; 30; 15; 12; 8.95 | — |
| SECONDARY Persistence of Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, W, Y |
47; 6.69; 4.41; 2.78; 180; 13 | — |
| SECONDARY Percentages of Subjects With Rabbit Serum Bactericidal ≥ 1:8, ≥ 1:128 and Four Fold Rise Against N.Meningitidis Serogroup C |
72; 4; 1; 98; 92; 97 | — |
| SECONDARY Percentages of Subjects With Rabbit Serum Bactericidal ≥ 1:8, ≥ 1:128, and Four Fold Rise Against N.Meningitidis Serogroup A, W, Y |
100; 98; 96; 93; 89; 86 | — |
| SECONDARY Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup C |
26; 2.22; 2.03; 353; 131; 266 | — |
| SECONDARY Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup A, W, Y |
281; 6.83; 3136; 3258; 20; 2.32 | — |
| SECONDARY Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 to Day 7 Postvaccination), After Any Vaccination |
130; 131; 135; 57; 65; 44 | — |
Eligibility Criteria
Inclusion Criteria
- infants 6 to 8 months old inclusive, who were born after full term pregnancy and previously received three doses of both Prevenar and Infanrix-hexa vaccines at least 30 days before study entry
Exclusion Criteria
- who previously received any meningococcal vaccine;
- who have had a previous confirmed or suspected disease caused by N. meningitidis, C. diphtheriae, C. tetani, Poliovirus, Hepatitis B, Hib, Pneumococcus or B. pertussis;
- who have had household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis (serogroups A, C, W135, or Y), B. pertussis, Hib, C. diphtheriae, Polio, or pneumococcal infection at any time since birth;
- Subjects with any serious, acute or chronic progressive disease
Data sourced from ClinicalTrials.gov (NCT00667602). 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.