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Clinical Study to Evaluate Antibody and Cell Mediated Immunity of A/H1N1 Influenza Vaccine in Healthy Subjects

NCT01079273 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2012-06-01

No results posted yet for this study

Summary

The purpose of this study is explore the antibody and cell mediated immune responses to one injection of Focetria™ pandemic influenza vaccine in healthy adults aged 18-60 years.

Conditions

Interventions

BIOLOGICAL

egg-derived A/H1N1 pandemic influenza vaccine

One 0.50 mL IM dose injection (7.5 µg of vaccine + 9.75 mg MF59)

Sponsors & Collaborators

  • Opera CRO, a TIGERMED Group Company

    lead OTHER

Principal Investigators

  • Franco Laghi Pasini, MD · Azienda Ospedaliera Universitaria Senese

  • Laura Michellini · Opera CRO, a TIGERMED Group Company

  • Fabio Montanaro, DSc · Opera CRO, a TIGERMED Group Company

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • Italy

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 NCT01079273 on ClinicalTrials.gov