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Study of Safety and Immunogenicity of Fluzone® in Healthy Children

Primary Purpose

Influenza

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Influenza Vaccine 2004-2005 Paediatric Formulation

About this trial

This is an interventional prevention trial for Influenza focused on measuring Influenza, Fluzone® vaccine, Infants, Toddlers

Eligibility Criteria

6 Months - 35 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria :

Participant is aged ≥ 6 months to < 36 months.
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/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.
Any vaccination in the 14 days preceding enrollment in the study or scheduled between Visit 1 and Visit 3.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Infants <12 Months

Toddlers ≥12 Months

Arm Description

Participants aged ≥ 6 to < 12 months at enrollment and received 2 doses of Fluzone® Vaccine

Participants aged ≥ 12 to < 36 months at enrollment and received 2 doses of Fluzone® vaccine

Outcomes

Primary Outcome Measures

Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation

Solicited local reactions: Erythema, bruising, induration, pain at injection site. Solicited systemic reactions: Fever (temperature), irritability, crying, lethargy, appetite decreased, diarrhea, vomiting, rash collected daily for four days after each injection.

Secondary Outcome Measures

Full Information

NCT ID

NCT00831675

First Posted

January 28, 2009

Last Updated

April 12, 2016

Sponsor

Sanofi Pasteur, a Sanofi Company

1. Study Identification

Unique Protocol Identification Number

NCT00831675

Brief Title

Study of Safety and Immunogenicity of Fluzone® in Healthy Children

Official Title

Annual Study for Serum Collection and Evaluation of Safety and Immunogenicity Among Healthy Children Receiving Influenza Virus Vaccine Fluzone® 2004-2005

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Completed

Study Start Date

September 2004 (undefined)

Primary Completion Date

April 2006 (Actual)

Study Completion Date

April 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi Pasteur, a Sanofi Company

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

To describe the safety of the 2004-2005 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 of the 2004-2005 inactivated, split-virion influenza vaccine Fluzone®, administered in a two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to < 36 months

Detailed Description

To provide the Centers for Biologic Evaluation and Research (CBER) with sera collected from healthy children receiving the 2004-2005 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study by the Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), and the World Health Organization (WHO).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza

Keywords

Influenza, Fluzone® vaccine, Infants, Toddlers

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

Infants <12 Months

Arm Type

Experimental

Arm Description

Participants aged ≥ 6 to < 12 months at enrollment and received 2 doses of Fluzone® Vaccine

Arm Title

Toddlers ≥12 Months

Arm Type

Experimental

Arm Description

Participants aged ≥ 12 to < 36 months at enrollment and received 2 doses of Fluzone® vaccine

Intervention Type

Biological

Intervention Name(s)

Influenza Vaccine 2004-2005 Paediatric Formulation

Other Intervention Name(s)

Fluzone®

Intervention Description

0.25 mL (Day 0 and Day 28), Intramuscular

Intervention Type

Biological

Intervention Name(s)

Influenza Vaccine 2004-2005 Paediatric Formulation

Other Intervention Name(s)

Fluzone®

Intervention Description

0.25 mL (Day 0 and Day 28), Intramuscular

Primary Outcome Measure Information:

Title

Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation

Description

Time Frame

Days 0-3 Post-dose

Other Pre-specified Outcome Measures:

Title

Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine 2004-2005 Pediatric Formulation

Time Frame

14 days post-vaccination

Title

Percentage of Participants With at Least a 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroprotection)

Description

Seroprotection defined as percentage of participants with reciprocal hemagglutination inhibition titers ≥40 post-vaccination with Fluzone®.

Time Frame

14 days post-vaccination

Title

Percentage of Participants With a 4-Fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroconversion)

Description

Seroconversion defined as the percentage of participants with a ≥ 4-fold increases in titer from pre- to post-vaccination with Fluzone®.

Time Frame

Day 14 post-vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

35 Months

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria : Participant is aged ≥ 6 months to < 36 months. 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/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. Any vaccination in the 14 days preceding enrollment in the study or scheduled between Visit 1 and Visit 3.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Sanofi Pasteur Inc.

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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Study of Safety and Immunogenicity of Fluzone® in Healthy Children

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