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Immunogenicity and Safety of Different rMenB Plus MenACWY Formulations in Adolescents

NCT01210885 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 495

Last updated 2011-10-24

No results posted yet for this study

Summary

The purpose of this phase 2 study is to evaluate the safety, tolerability and immunogenicity of two doses of 4 different investigational MenABCWY combination vaccine when administered to healthy adolescents aged 11-18 years.

Conditions

  • Meningococcal Disease
  • Meningococcal Meningitis

Interventions

BIOLOGICAL

Meningococcal Vaccine

MenABCWY combination vaccine containing four different rMenB formulations with MenACWY, intramuscular (IM) administration, vaccination at 0 and 2 months.

Sponsors & Collaborators

  • Novartis Vaccines

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
11 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • Chile
  • Colombia
  • Panama

Study Locations

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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 NCT01210885 on ClinicalTrials.gov