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Safety and Immune Response of Novartis MenACWY-CRM Conjugate Vaccine When Given to Healthy Toddlers

NCT00626327 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1630

Last updated 2013-04-19

Study results available
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Summary

Safety immune response of Novartis MenACWY-CRM conjugate vaccine when given to healthy toddlers

Conditions

  • Meningococcal Infections

Interventions

BIOLOGICAL

MenACWY-CRM + MMRV

One injection of MenACWY-CRM vaccine at 7-9 months of age; the second injection of MenACWY-CRM vaccine concomitantly administered with MMRV (Measles, Mumps, Rubella and Varicella) vaccine at 12 months of age.

BIOLOGICAL

MMRV

one injection of MMRV (Measles, Mumps, Rubella and Varicella) vaccine at 12 months of age

BIOLOGICAL

MenACWY-CRM

Two injections of MenACWY-CRM at 7-9 months and 12 months of age; one injection of MMRV (Measles, Mumps, Rubella and Varicella) at 13.5 months of age

Sponsors & Collaborators

  • Novartis Vaccines

    lead INDUSTRY

Principal Investigators

  • Novartis Vaccines · Novartis Vaccines

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
7 Months
Max Age
1 Year
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2010-07-31
Completion
2010-10-31

Countries

  • United States

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 NCT00626327 on ClinicalTrials.gov