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Safety and Immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Children Aged 12-59 Months.

NCT00310817 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 623

Last updated 2015-11-06

Study results available
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Summary

To compare the functional immune response 28 days after administration of one dose of Men ACWY-CRM conjugate vaccine without adjuvant (MenACWY-CRM(Ad-)) with that of a Men ACWY polysaccharide (PS) vaccine

Conditions

  • Meningococcal Meningitis

Interventions

BIOLOGICAL

MenACWY-CRM conjugate vaccine, adjuvanted

BIOLOGICAL

MenACWY polysaccharide vaccine

BIOLOGICAL

MenACWY-CRM conjugate vaccine, unadjuvanted

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Novartis Vaccines

    lead INDUSTRY

Principal Investigators

  • Novartis Vaccines - Drug Information Services · Novartis

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE

Eligibility

Min Age
12 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-03-31
Primary Completion
2006-05-31
Completion
2006-05-31

Countries

  • Finland
  • Poland

Study Locations

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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 NCT00310817 on ClinicalTrials.gov