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Safety of a Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine in Healthy Subjects in Vietnam

NCT02640404 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2018-01-08

Study results available
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Summary

The aim of the study is to assess the safety of Menactra vaccine in infants, toddlers, children, adolescents, and adults

Objective:

* To describe the safety profile after each and any dose (when applicable) of Menactra vaccine in participants aged 9 months to 55 years for registration.

Conditions

  • Meningitis
  • Meningococcal Meningitis
  • Meningococcal Infections

Interventions

BIOLOGICAL

Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine

0.5 mL, Intramuscular. 2 doses 3 months apart

BIOLOGICAL

Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine

0.5 mL, Intramuscular.

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur Asia Pacific

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
9 Months
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-06-06
Primary Completion
2016-12-05
Completion
2016-12-05
FDA Drug
Yes

Countries

  • Vietnam

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 NCT02640404 on ClinicalTrials.gov