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Post-Marketing Safety Study of Menactra® in Healthy Children, Adolescents, and Adults in the Philippines

NCT01270503 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 538

Last updated 2014-11-14

Study results available
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Summary

This aim of the study is to assess post-marketing safety of a single dose of Menactra® vaccine with the intent to support conversion from monitored release to initial registration of Menactra® vaccine in the Philippines.

Primary Objective:

To describe the serious adverse events occurring within 30 days among participants who have received one dose of Menactra® vaccine.

Conditions

Interventions

BIOLOGICAL

Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate

0.5 mL, Intramuscular

BIOLOGICAL

Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate

0.5 mL, Intramuscular

BIOLOGICAL

Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate

0.5 mL, Intramuscular

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur Philippines, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2013-12-31
Completion
2014-07-31

Countries

  • Philippines

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 NCT01270503 on ClinicalTrials.gov