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Immunogenicity and Safety of a Quadrivalent Influenza Vaccine Given by Intramuscular Route in Subjects Aged 18 to 60 Years

NCT02550197 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2022-03-28

Study results available
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Summary

The aim of the trial is to evaluate immunogenicity and safety of the quadrivalent influenza vaccine (QIV) and the trivalent influenza vaccine (TIV) (split-virion inactivated) Northern Hemisphere (NH) 2015 2016 seasonal formulations, in subjects aged 18 to 60 years in the Republic of Korea for the registration of the QIV by the Ministry of Food and Drug Safety.

Objectives:

* To evaluate the immunogenicity of QIV and TIV (split-virion, inactivated) NH 2015-2016 seasonal formulations. The compliance, in terms of immunogenicity, of the QIV NH 2015-2016 formulation, with the requirements of the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96 will be assessed.
* To evaluate the safety profile of QIV and TIV (split-virion, inactivated) NH 2015-2016 seasonal formulations

Conditions

Interventions

BIOLOGICAL

Quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016

0.5 mL, Intramuscular

BIOLOGICAL

Trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation

0.5 mL, Intramuscular

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
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2016-04-30
Completion
2016-07-31

Countries

  • South Korea

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 NCT02550197 on ClinicalTrials.gov