Phase 2
N=54
Safety, Tolerability and Immunogenicity of Three Doses of Novartis Meningococcal B Vaccine When Administered to Healthy At-risk Adults
Meningococcal Disease
Bottom Line
View on ClinicalTrials.gov: NCT00560313 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Jul 2011
Primary outcome: Primary: Geometric Mean Titer of the Meningococcal B Vaccine Against the Different Strains at One Month After First, Second and Third Vaccination. — 2.5; 2.3; 1.8; 33 titer
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Men ACWY CRM (Biological); 4CMenB (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Vaccines
- Primary completion
- Nov 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Titer of the Meningococcal B Vaccine Against the Different Strains at One Month After First, Second and Third Vaccination. |
2.5; 2.3; 1.8; 33; 29; 23 | — |
| PRIMARY Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination. |
37; 37; 22; 84; 88; 80 | — |
| PRIMARY Geometric Mean Titer (GMT) of the Meningococcal ACWY Vaccine at One Month After Vaccination. |
54; 42; 90; 36 | — |
| PRIMARY Percentage of Participants With Serum Bactericidal Activity of the Meningococcal ACWY Vaccine at One Month After Vaccination |
96; 100; 100; 83; 96; 96 | — |
| PRIMARY Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. |
52; 50; 50; 10; 8; 7 | — |
Summary
This study is aimed to evaluate safety, tolerability and immunogenicity of three doses of Novartis 4CMenB and of one dose of Novartis Meningococcal ACWY vaccine when administered to healthy at-risk adults.
Eligibility Criteria
Inclusion Criteria
- Healthy adults, 18 through 50 years of age, who were or might be routinely exposed to N. meningitidis cultures
Exclusion Criteria
- Previous ascertained or suspected disease caused by N. meningitidis;
- Pregnancy or breastfeeding;
- History of any anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component;
- Any present or suspected serious acute or chronic disease
- Known or suspected autoimmune disease or impairment /alteration of immune function
Data sourced from ClinicalTrials.gov (NCT00560313). 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.