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Study of a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route in Children and Adolescents in Taiwan

NCT01967784 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2016-01-20

Study results available
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Summary

The aim of the study is to describe the immunogenicity and safety of the new formulation of Quadrivalent Influenza Vaccine (QIV) for the 2013-2014 season in the Northern Hemisphere (NH) in subjects aged 9 to 17 years in Taiwan

Primary Objective:

* To describe the immunogenicity of the QIV (split-virion, inactivated) NH seasonal formulation

Secondary Objective:

* To describe the safety of the QIV (split-virion, inactivated) NH seasonal formulation

Conditions

Interventions

BIOLOGICAL

Quadrivalent Influenza Vaccine (split virion, inactivated)

0.5 mL, Intramuscular

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur SA

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
9 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2014-04-30
Completion
2014-07-31

Countries

  • Taiwan

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 NCT01967784 on ClinicalTrials.gov