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Phase IV Trial to Collect Safety Data and Sera in Healthy Children Given Fluzone Vaccine

Primary Purpose

Influenza

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Influenza Virus Vaccine (Fluzone®)
Influenza Virus Vaccine (Fluzone®)
Sponsored by
Sanofi Pasteur, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring Fluzone®, Influenza Virus Vaccine

Eligibility Criteria

6 Months - 36 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Participant is aged ≥ 6 months (24 weeks) to < 36 months (3rd birthday). Participant is considered to be in good health on the basis of reported medical history and limited physical examination. Participant is available for the duration of the study. Parent/legal acceptable representative is willing and able to provide informed consent. Parent/legal acceptable representative is willing and able to meet protocol requirements. Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg. Exclusion Criteria: Reported allergy to egg proteins, chicken proteins, or any other constituent of the vaccine. 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 (Enrollment may be deferred). Clinically significant findings in vital signs or review of systems (investigator judgment; defer or exclude). Participation in any other interventional 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Influenza Virus Vaccine Naïve

Influenza Virus Vaccine-primed

Arm Description

Subjects have never received Influenza virus vaccine in the past

Subjects have received Influenza virus vaccine in the past

Outcomes

Primary Outcome Measures

Geometric Mean Titer (GMT) of Hemagglutination Inhibition Antibodies Pre-vaccination and 14 Days Post-vaccination
GMTs and their 95% Confidence interval are presented for each of the 3 antigens in the Fluzone® vaccine 2005-2006 Pediatric formulation. Post-dose 1 (Influenza vaccine Primed group); post-dose 2 (Influenza vaccine Naive group)

Secondary Outcome Measures

Full Information

First Posted
November 24, 2005
Last Updated
April 12, 2016
Sponsor
Sanofi Pasteur, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00258817
Brief Title
Phase IV Trial to Collect Safety Data and Sera in Healthy Children Given Fluzone Vaccine
Official Title
Annual Study for Serum Collection and Evaluation of Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Influenza Virus Vaccine (2005-2006 Formulation)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi Pasteur, a Sanofi Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To provide serum to the Food and Drug Administration (FDA) for use by FDA, the Centers for Disease Control and Prevention (CDC), and the World Health Organization (WHO) for characterization of circulating influenza strains. Observational Objectives: To describe the safety of the 2005-2006 pediatric formulation of Fluzone vaccine, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to < 36 months. To describe the immunogenicity of the 2005-2006 pediatric formulation of Fluzone vaccine, administered in a two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to < 36 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Fluzone®, Influenza Virus Vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Influenza Virus Vaccine Naïve
Arm Type
Experimental
Arm Description
Subjects have never received Influenza virus vaccine in the past
Arm Title
Influenza Virus Vaccine-primed
Arm Type
Experimental
Arm Description
Subjects have received Influenza virus vaccine in the past
Intervention Type
Biological
Intervention Name(s)
Influenza Virus Vaccine (Fluzone®)
Other Intervention Name(s)
Fluzone®
Intervention Description
0.25 mL, Intramuscular (Day 0 and Day 28)
Intervention Type
Biological
Intervention Name(s)
Influenza Virus Vaccine (Fluzone®)
Other Intervention Name(s)
Fluzone®
Intervention Description
0.25 mL, Intramuscular (Day 0)
Primary Outcome Measure Information:
Title
Geometric Mean Titer (GMT) of Hemagglutination Inhibition Antibodies Pre-vaccination and 14 Days Post-vaccination
Description
GMTs and their 95% Confidence interval are presented for each of the 3 antigens in the Fluzone® vaccine 2005-2006 Pediatric formulation. Post-dose 1 (Influenza vaccine Primed group); post-dose 2 (Influenza vaccine Naive group)
Time Frame
Day 14 post-vaccination
Other Pre-specified Outcome Measures:
Title
Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1
Description
Solicited local reactions: injection site erythema, injection site swelling, injection site tenderness; Solicited systemic reactions: fever (temperature), irritability, abnormal crying, drowsiness, lost appetite, and vomiting.
Time Frame
0 to 3 days post-vaccination 1
Title
Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 2
Description
Solicited local reactions: injection site erythema, injection site swelling, injection site tenderness; Solicited systemic reactions: fever (temperature), irritability, abnormal crying, drowsiness, lost appetite, and vomiting Note: Influenza vaccine-primed group received only dose 1
Time Frame
0 to 3 days post-vaccination 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participant is aged ≥ 6 months (24 weeks) to < 36 months (3rd birthday). Participant is considered to be in good health on the basis of reported medical history and limited physical examination. Participant is available for the duration of the study. Parent/legal acceptable representative is willing and able to provide informed consent. Parent/legal acceptable representative is willing and able to meet protocol requirements. Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg. Exclusion Criteria: Reported allergy to egg proteins, chicken proteins, or any other constituent of the vaccine. 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 (Enrollment may be deferred). Clinically significant findings in vital signs or review of systems (investigator judgment; defer or exclude). Participation in any other interventional 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Sanofi Pasteur, a Sanofi Company
Official's Role
Study Director
Facility Information:
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23510
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.sanofipasteur.com
Description
Related Info

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Phase IV Trial to Collect Safety Data and Sera in Healthy Children Given Fluzone Vaccine

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