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Trials / Completed

CompletedNCT00561002

Phase IV Trial to Collect Safety Data and Sera for Immunogenicity Testing in Healthy Children Given Fluzone® Vaccine

Annual Study for Serum Collection and Evaluation of Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Influenza Virus Vaccine (2007-2008 Formulation)

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
34 (actual)
Sponsor
Sanofi Pasteur, a Sanofi Company · Industry
Sex
All
Age
6 Months – 35 Months
Healthy volunteers
Accepted

Summary

To provide Centers for Biologic Evaluation and Research (CBER) with sera collected from healthy children receiving the 2007-2008 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study.

Conditions

Interventions

TypeNameDescription
BIOLOGICAL2007-2008 Influenza Virus Vaccine0.25 mL, Intramuscular
BIOLOGICAL2007-2008 Influenza Virus Vaccine0.25 mL, Intramuscular

Timeline

Start date
2007-10-01
Primary completion
2008-05-01
Completion
2008-06-01
First posted
2007-11-20
Last updated
2016-04-14
Results posted
2009-08-27

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00561002. Inclusion in this directory is not an endorsement.

Phase IV Trial to Collect Safety Data and Sera for Immunogenicity Testing in Healthy Children Given Fluzone® Vaccine (NCT00561002) · Clinical Trials Directory