Phase 3
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
Bottom Line
View on ClinicalTrials.gov: NCT00450437 ↗Enrolled (actual)
3,539
Serious AEs
0.8%
Results posted
Sep 2010
Primary outcome: Primary: Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years — 29; 33; 31; 77 Titers
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- MenACWY CRM (Biological); Meningococcal ACWY Conjugate vaccine (Biological)
- Age
- Pediatric, Adult · 11+ yrs
- Sex
- All
- Sponsor
- Novartis Vaccines
- Primary completion
- Aug 2007
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 | — |
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.
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.