Phase 2 N=382 Prevention

Evaluation of Meningococcal ACWY Immune Response in Children Aged 40 and 60 Months

Meningococcal Disease

Bottom Line

View on ClinicalTrials.gov: NCT00601731 ↗

Enrolled (actual)

382

Serious AEs

2.3%

Results posted

Sep 2012

Primary outcome: Primary: Percentage of Subjects With hSBA ≥1:8 — 27; 8; 29; 3 Percentages of subjects

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: MenACWY-CRM197 (Biological); Blood test (Biological)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Novartis Vaccines
Primary completion: Jul 2010

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	—

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.

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

View full record on ClinicalTrials.gov →

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.