Phase 2
N=155
A Study to Evaluate the Persistence and Immune Response to a Booster Dose of MenACWY
Meningococcal Disease · Meningococcal Meningitis
Bottom Line
View on ClinicalTrials.gov: NCT01018732 ↗Enrolled (actual)
155
Serious AEs
0.0%
Results posted
Sep 2011
Primary outcome: Primary: Percentage of Participants With Serum Bactericidal Activity >=8 at 5 Years After Primary Vaccination — 30; 44; 11; 76 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Novartis Meningococcal (MenACWY-CRM) vaccine (Biological)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- All
- Sponsor
- Novartis Vaccines
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Serum Bactericidal Activity >=8 at 5 Years After Primary Vaccination |
30; 44; 11; 76; 62; 51 | — |
| PRIMARY Geometric Mean Titer After Booster Vaccination |
5.16; 7.31; 3.06; 1059; 45; 34 | — |
| SECONDARY Percentage of Participants With Serum Bactericidal Activity >=4 at 5 Years After Primary Vaccination |
34; 50; 23; 84; 68; 70 | — |
| SECONDARY Geometric Mean Titer at 5 Years After Primary Vaccination |
5.21; 7.56; 3; 20; 19; 7.62 | — |
| SECONDARY Percentage of Participants With Serum Bactericidal Activity >=4 After Booster Vaccination |
100; 76; 66; 98; 94; 92 | — |
| SECONDARY Percentage of Participants With Serum Bactericidal Activity >=8 After Booster Vaccination |
100; 73; 64; 98; 94; 92 | — |
| SECONDARY Geometric Mean Ratio After Booster Vaccination |
205; 6.1; 11; 155; 20; 37 | — |
| SECONDARY Percentage of Subjects With hSBA Seroresponse After Booster Vaccination |
100; 51; 60; 100; 76; 90 | — |
| SECONDARY Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination |
30; 32; 40; 29; 27; 33 | — |
Summary
The primary objective is to evaluate the persistence of bactericidal antibodies in adolescent subjects who completed study V59P6 in which they received either Novartis Meningococcal (MenACWY) Conjugate Vaccine or Licensed polysaccharide Men ACWY vaccine (Menomune®). The study will also enroll age-matched subjects who have never received any other meningococcal vaccine (naïve subjects) to serve as an additional control group.
Eligibility Criteria
Inclusion Criteria
- Healthy adolescents or adults (age 16-23 years inclusive), either previously enrolled in the parent study or naïve to meningococcal vaccination.
- Female subjects were to be negative for pregnancy
Exclusion Criteria
- History of meningococcal disease
- Receipt of any meningococcal vaccine outside of parent study (V59P6)
- Serious, acute, or chronic illnesses including HIV infection/disease and any malignancy
- receipt of any vaccine 14 days prior to the study, or expected through the duration of the study
- any condition which in the eyes of the investigator would pose a health risk to the subject or render them inappropriate for a research study
Data sourced from ClinicalTrials.gov (NCT01018732). 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.