Phase 3
N=2,831
A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Healthy Adults
Meningococcal Meningitis · Meningococcal Infections
Bottom Line
View on ClinicalTrials.gov: NCT00474487 ↗Enrolled (actual)
2,831
Serious AEs
0.8%
Results posted
Aug 2010
Primary outcome: Primary: Number of Subjects With at Least One Severe Systemic Reaction, Ages 19 to 55 Years — 95; 46 Subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Meningococcal ACWY Polysaccharide Vaccine (Biological); MenACWY CRM (19 to 55 years) (Biological); Meningococcal ACWY Conjugate Vaccine (Biological); Novartis MenACWY Vaccine (56 to 65 Years) (Biological)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- Novartis Vaccines
- Primary completion
- Aug 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With at Least One Severe Systemic Reaction, Ages 19 to 55 Years |
95; 46 | — |
| SECONDARY Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 19 to 55 Years), PP Population |
78; 77; 83; 81; 66; 53 | — |
| SECONDARY Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 56 to 65 Years), PP Population |
86; 61; 83; 73; 61; 54 | — |
| SECONDARY Summary of hSBA GMTs (Ages 19 to 55 Years), PP Population |
77; 52; 114; 88; 159; 112 | — |
| SECONDARY Summary of hSBA GMTs (Ages 56 to 65 Years), PP Population |
111; 21; 196; 86; 164; 132 | — |
| SECONDARY Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years |
729; 439; 632; 392; 207; 105 | — |
| SECONDARY Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years |
92; 44; 69; 34; 41; 13 | — |
Summary
This study will evaluate the safety and immune response of Novartis Meningococcal ACWY conjugate vaccine in healthy adolescents and adults.
Eligibility Criteria
Inclusion Criteria
- individuals who are 19-65 years of age inclusive and who, after the nature of the study has been explained have provided written informed consent
- individuals who are available for all visits and telephone calls scheduled for the study;
- individuals who are in good health
Exclusion Criteria
- individuals with a previous or suspected disease caused by N. meningitidis
- individuals with previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s)
- individuals with previous or suspected disease caused by N. meningitidis
- individuals with any serious acute, chronic or progressive disease
- individuals who are pregnant or breastfeeding
Data sourced from ClinicalTrials.gov (NCT00474487). 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.