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A Study to Evaluate the Persistence and Immune Response to a Booster Dose of MenACWY

NCT01018732 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 155

Last updated 2015-07-15

Study results available
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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.

Conditions

  • Meningococcal Disease
  • Meningococcal Meningitis

Interventions

BIOLOGICAL

Novartis Meningococcal (MenACWY-CRM) vaccine

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

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Novartis Vaccines

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
23 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01018732 on ClinicalTrials.gov