Phase 3
Completed N=3,539
A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In US Adolescents and Adults
Meningococcal Infections · Meningococcal Meningitis
Source: ClinicalTrials.gov NCT00450437 ↗
Enrolled (actual)
3,539
Serious AEs
0.8%
Results posted
Sep 2010
Primary outcomePrimary: Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years — 29; 33; 31; 77 Titers
Summary
This study will evaluate the lot to lot consistency, safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine in healthy US adolescents and adults.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years |
29; 33; 31; 77; 58; 64 | — |
| PRIMARY Percentage of Seroresponders, Ages 11 to 18 Years |
75; 66; 75; 73; 75; 63 | — |
| PRIMARY Number of Participants With at Least One Severe Systemic Reaction, Ages 11 to 55 Years |
94; 24 | — |
| PRIMARY Percentage of Seroresponders, Ages 19 to 55 Years |
67; 68; 67; 58; 50; 41 | — |
| SECONDARY Lot to Lot Consistency for the Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and ≥ 1:4, Ages 11 to 18 Years |
71; 75; 77; 78; 73; 74 | — |
| SECONDARY Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and hSBA Titer ≥ 1:4, Ages 11 to 55 Years |
71; 67; 72; 67; 67; 52 | — |
| SECONDARY Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers, Ages 11 to 55 Years |
29; 22; 55; 39; 100; 57 | — |
| SECONDARY Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years |
1105; 424; 414; 126; 324; 88 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy subjects who are 11-55 years of age inclusive and who have given appropriate written assent and/or consent
Exclusion Criteria
- Subjects with a previous or suspected disease caused by N. meningitidis
- previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s)
- previous or suspected disease caused by N. meningitidis
- Any serious acute, chronic or progressive disease
- Pregnant or breastfeeding
Data sourced from ClinicalTrials.gov (NCT00450437). 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.