MedTrace Logo

Study of Inactivated, Split-Virion Influenza Vaccine Administered by Intradermal Route Versus Vaxigrip® in Adults

NCT00703651 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1150

Last updated 2014-01-13

No results posted yet for this study

Summary

This is a follow-up of a previous dose-ranging study aimed at investigating 2 doses of the trivalent inactivated split virion influenza vaccine when administered by intradermal route with that of the current pharmaceutical presentation administered by intramuscular route.

Primary Objective:

To assess the immunogenicity of two pharmaceutical presentations of the trivalent inactivated split virion influenza vaccine 21 days after a single injection in subjects aged 18 to 57 years.

Secondary Objective:

To evaluate the safety profile during the 21-day period following each vaccination in each study group

Conditions

  • Influenza
  • Orthomyxoviridae Infection
  • Myxovirus Infection

Interventions

BIOLOGICAL

Inactivated, split-virion influenza vaccine

0.1 mL, ID. 1 injection/year for 3 years

BIOLOGICAL

Inactivated, split-virion influenza vaccine

0.1 mL, ID. 1 injection/year for 3 years.

BIOLOGICAL

Inactivated, split-virion influenza vaccine

0.5 mL, IM. 1 injection/year for 3 years

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Sanofi Pasterur Inc

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
57 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-09-30
Primary Completion
2006-05-31
Completion
2006-07-31

Countries

  • Belgium
  • Czechia
  • Lithuania

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 NCT00703651 on ClinicalTrials.gov