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Study of Sanofi Pasteur and Lanzhou Institute's Meningococcal (Group A and C) Polysaccharide Vaccine in Children

NCT01430611 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 666

Last updated 2014-05-08

Study results available
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Summary

This study is part of the post-licensure commitment to evaluate the safety and immunogenicity of Meningo A+C vaccine in healthy Chinese children 2 to 6 years of age.

Primary Objective:

To demonstrate the non-inferiority in terms of seroconversion rate for serogroups A and C, 30 days after a single dose of Sanofi Pasteur Meningococcal (Groups A and C) Polysaccharide Vaccine versus Lanzhou Institute for Biological Products Meningococcal (Groups A and C) Polysaccharide Vaccine.

Secondary Objective:

* To describe the immunogenicity for serogroups A and C, 30 days after administration of the study vaccines given as a single dose.
* To describe the full reactogenicity profile after administration of the study vaccines given as a single dose.

Conditions

Interventions

BIOLOGICAL

Meningococcal (Groups A and C) Polysaccharide Vaccine

0.5 mL, Subcutaneous

BIOLOGICAL

Meningococcal (Groups A and C) Polysaccharide Vaccine

0.5 mL, Subcutaneous

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur SA

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2012-08-31
Completion
2012-11-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT01430611 on ClinicalTrials.gov