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Safety and Immunogenicity of a Quadrivalent Meningococcal Tetanus Protein Conjugate Vaccine in Toddlers

NCT00631995 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2018-02-06

No results posted yet for this study

Summary

This study is aimed at studying quadrivalent meningococcal (A, C, Y, and W-135) Tetanus Protein Conjugate Vaccine (TetraMen-T) formulations in Toddlers.

Primary Objectives: Safety and Immunogenicity:

To describe the safety and immunogenicity profiles of:

* A single dose of each formulation of TetraMen-T vaccine
* A single dose of NeisVac-C® vaccine.

Conditions

Interventions

BIOLOGICAL

Meningococcal Polysaccharide Tetanus Protein Conjugate

0.5 mL, Intramuscular

BIOLOGICAL

Meningococcal Polysaccharide Tetanus Protein Conjugate

0.5 mL, Intramuscular

BIOLOGICAL

Meningococcal Polysaccharide Tetanus Protein Conjugate

0.5 mL, Intramuscular

BIOLOGICAL

Meningococcal Polysaccharide Tetanus Protein Conjugate

0.5 mL, Intramuscular

BIOLOGICAL

Meningococcal Polysaccharide Tetanus Protein Conjugate

0.5 mL, Intramuscular

DIETARY_SUPPLEMENT

Meningococcal polysaccharide group C conjugated

0.5 mL, Intramuscular

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2009-02-28
Completion
2009-04-30

Countries

  • Australia

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 NCT00631995 on ClinicalTrials.gov