CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 155 enrolled
Drug / intervention
Novartis Meningococcal (MenACWY-CRM) vaccinebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01018732
NCT01018732Phase 2Completed
CompareCT.gov

A Phase 2b, Open-Label, Multi-Center Study to Evaluate the Persistence of Antibody Response and to Assess the Immune Response to a Booster Dose of MenACWY Conjugate Vaccine in Subjects Previously Vaccinated as Adolescents With Either MenACWY Conjugate Vaccine or Menomune®.

Novartis Vaccines·interventional·Posted Nov 25, 2009·Updated Jul 15, 2015

In Brief

A Phase 2 clinical trial evaluating Novartis Meningococcal (MenACWY-CRM) vaccine for Meningococcal Disease and Meningococcal Meningitis. Completed, enrolled 155 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeningococcal Disease, Meningococcal Meningitis
CountriesUnited States
CollaboratorsNovartis

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 25, 2009
Enrollment StartJan 1, 2010
Primary CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 16.6 years ago

Interventions

Novartis Meningococcal (MenACWY-CRM) vaccinebiological

All subjects will have blood draws at Day 1, Day 8, and Day 29.