Phase 2
Completed N=382
Evaluation of Meningococcal ACWY Immune Response in Children Aged 40 and 60 Months
Source: ClinicalTrials.gov NCT00601731 ↗Enrolled (actual)
382
Serious AEs
2.3%
Results posted
Sep 2012
Primary outcomePrimary: Percentage of Subjects With hSBA ≥1:8 — 27; 8; 29; 3 Percentages of subjects
Summary
The purpose of this study is to evaluate how well the immuno response against meningococcal serogroups A, C, W and Y lasts in children who were vaccinated with MenACWY as infants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With hSBA ≥1:8 |
27; 8; 29; 3; NA; 0 | — |
| SECONDARY Percentage of Subjects With hSBA ≥1:4 |
30; 8; 29; 3; NA; 0 | — |
| SECONDARY GMTs in Subjects Within Each Site and in Age-Matched Control Subjects |
3.75; 2.58; 4.33; 2.08; NA; 2.01 | — |
Eligibility Criteria
Inclusion Criteria
- Follow-on, healthy 40, 60 months old participants who have completed the V59P5 study and are in good health
- Control subjects: healthy 60 months old who had received a complete MenC immunization course
Exclusion Criteria
- Subjects with any serious, acute or chronic progressive disease
Data sourced from ClinicalTrials.gov (NCT00601731). 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.