Study to Collect Sera for Immunogenicity Testing in Children Vaccinated With Fluzone®

April 12, 2016 updated by: Sanofi Pasteur, a Sanofi Company

A Trial for the Collection of Sera in Healthy Children Receiving Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone® 2003/2004

To describe the safety findings from Days 0 to 44 following injection of the 2003-2004 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to < 36 months.

To describe the immunogenicity findings from Days 0 to 44 following injection of the 2003-2004 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to < 36 months

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study is to collect sera from healthy children being administered the 2003-2004 formulation of the inactivated, split-virion influenza vaccine Fluzone®.

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria :

  • Aged ≥ 6 months to < 36 months.
  • Considered to be in good health on the basis of reported medical history and limited physical examination.
  • Available for the duration of the study (44 days +4 days).
  • Parent/guardian is willing and able to provide informed consent.
  • Parent/guardian is willing and able to meet protocol requirements.

Exclusion Criteria :

  • Reported allergy to egg proteins, chicken proteins, or any other constituent of the vaccine.
  • Previous history of influenza vaccination or documented history of influenza infection.
  • An acute illness with or without fever (temperature > 100.4 °F rectal) in the 72 hours preceding enrollment in the trial (defer enrollment).
  • Clinically significant findings in vital signs or review of systems (investigator judgment; defer or exclude).
  • Participation in any other clinical trial within 30 days prior to enrollment up to termination of the subject's participation in the study.
  • Known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth.
  • Personal or immediate family history of congenital immune deficiency.
  • Developmental delay, neurologic disorder, or seizure disorder.
  • Chronic medical, congenital, or developmental disorder.
  • Known human immunodeficiency virus (HIV)-positive mother.
  • Prior history of Guillain-Barré syndrome.
  • Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study Group
Participants received 2 doses of Fluzone® vaccine
Biological: Influenza virus vaccine (Pediatric formulation)
0.25 mL, Intramuscular
Other Names:
  • Fluzone®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination
Time Frame: Day 0 to 3 post-vaccination
Solicited local reactions: Erythema (redness), induration, bruising and pain at the injection site. Solicited systemic reactions: Fever (temperature), irritability, crying, lethargy, appetite decreased, diarrhea, vomiting and rash.
Day 0 to 3 post-vaccination

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Pre- and Post-Vaccination Reciprocal Hemagglutination Inhibition Titers ≥ 40 (Seroprotection)
Time Frame: Day 0 and Day 14 after Dose 2
Seroprotection defined as percentage of participants with reciprocal hemagglutination inhibition titers ≥40 pre- and post-vaccination.
Day 0 and Day 14 after Dose 2
Percentage of Participants With at Least a 4-fold Rise in Reciprocal Hemagglutination Inhibition Titers (Seroconversion)
Time Frame: Day 0 and Day 14 Post-dose 2
Seroconversion defined as the percentage of participants with ≥ 4-fold increases in reciprocal hemagglutination inhibition titer from pre- to post-vaccination.
Day 0 and Day 14 Post-dose 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi Pasteur, a Sanofi Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Primary Completion (Actual)

January 1, 2004

Study Completion (Actual)

July 1, 2004

Study Registration Dates

First Submitted

February 3, 2009

First Submitted That Met QC Criteria

February 3, 2009

First Posted (Estimate)

February 4, 2009

Study Record Updates

Last Update Posted (Estimate)

April 14, 2016

Last Update Submitted That Met QC Criteria

April 12, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GRC17

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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