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Study of Sanofi Pasteur's Intradermal Influenza Vaccine (IDflu™) in Adults and Elderly in Korea

NCT01215669 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2018-09-13

No results posted yet for this study

Summary

This study is designed to assess the immunogenicity and safety of the 2010-2011 NH season formulation of intradermal (ID) influenza vaccine as part of a post registration commitment.

Objectives:

* For all groups, to evaluate compliance, in terms of immunogenicity, of the corresponding strength of the intradermal (ID) or intramuscular (IM) influenza vaccine Northern Hemisphere (NH) 2010 2011 formulation with the requirements of the Committee for Human Medicinal Products (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96
* For all groups, to describe the safety

Conditions

Interventions

BIOLOGICAL

IDflu™: Split virion inactivated influenza vaccine

Single dose 0.1 mL, intradermal

BIOLOGICAL

Vaxigrip®: Split virion inactivated influenza vaccine

Single dose 0.5 mL, intramuscular

BIOLOGICAL

IDflu™: Split virion inactivated influenza vaccine

Single dose 0.1 mL, intradermal

BIOLOGICAL

Vaxigrip®: Split virion inactivated influenza vaccine

Single dose 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
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2011-02-28
Completion
2011-04-30

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 NCT01215669 on ClinicalTrials.gov