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A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Infants

NCT00474526 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4545

Last updated 2014-03-24

Study results available
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Summary

This study will evaluate the safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine when administered with routine infant vaccinations to healthy infants.

Conditions

  • Meningitis, Meningococcal

Interventions

BIOLOGICAL

Meningococcal ACWY Conjugate Vaccine

BIOLOGICAL

DTaP-IPV-HBV

BIOLOGICAL

Hib

BIOLOGICAL

Rotavirus

BIOLOGICAL

Pneumococcal 7-valent Conjugate Vaccine

BIOLOGICAL

HAV

BIOLOGICAL

MMR-V

BIOLOGICAL

DTaP

Sponsors & Collaborators

  • Novartis Vaccines

    lead INDUSTRY

Principal Investigators

  • Novartis - Vaccines · Novartis Vaccines & Diagnostics

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
2 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2008-09-30
Completion
2009-11-30

Countries

  • United States
  • Argentina
  • Colombia

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 NCT00474526 on ClinicalTrials.gov