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Comparative Study of Immunogenicity and Safety of Flu-ID Vaccine Versus Flu-IM Vaccine

NCT00554333 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 795

Last updated 2018-03-16

No results posted yet for this study

Summary

Primary objective:

\* Immunogenicity To demonstrate that the influenza vaccine administered by intradermal route at least as immunogenic as the adjuvanted influenza vaccine administered by intramuscular route at the same dosage in term of HA antibody titres

Secondary objectives

* Immunogenicity

* To describe the immune response 21 days after vaccination with the influenza vaccine administered by ID route versus the adjuvanted influenza vaccine administered by IM route..
* To describe the compliance of both vaccines administered with the European Medicine Agency (EMEA) Note for Guidance immunogenicity criteria, specific for elderly subjects
* Safety

\- To describe the safety profile after vaccination in each group
* Acceptability

* To describe the pain at the injection site
* To describe the comfort of the injection

Conditions

Interventions

BIOLOGICAL

Flu-ID 15μg

Inactivated Split-Virion Influenza Vaccine for Intradermal Route

BIOLOGICAL

Inactivated adjuvanted Influenza Vaccine

Inactivated adjuvanted Influenza Vaccine for Intramuscular Route

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur, a Sanofi Company

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2007-12-31
Completion
2007-12-31

Countries

  • Belgium
  • France

Study Locations

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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 NCT00554333 on ClinicalTrials.gov