Back to resultsAnnual Study for Serum Collection for Immunogenicity and Safety Evaluation in Healthy Children Receiving Fluzone®
Primary Purpose
Influenza, Orthomyxoviridae Infections
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Influenza Virus Vaccine No Preservative: Pediatric Dose
Influenza Virus Vaccine No Preservative: Pediatric Dose
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring Influenza, Orthomyxoviruses, Orthomyxoviridae Infections, Influenza vaccine
Eligibility Criteria
Inclusion Criteria:
- Participant is ≥ 6 months to < 5 years of age.
- Participant is considered to be in good health on the basis of reported medical history and a limited history-directed physical examination.
- Parent/legal acceptable representative is willing and able to bring the subject to the scheduled visits and to comply with the study procedures during the entire duration of the study.
- Parent/legal acceptable representative is willing and able to provide informed consent.
- Subject was born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg (5.5 lbs).
Exclusion Criteria:
- Reported allergy to egg proteins, chicken proteins, or any other constituent of the vaccine.
- History of severe adverse event to any influenza vaccine.
- Laboratory-confirmed influenza infection or vaccination against influenza in the 6 months preceding enrollment in the study.
- Any vaccination scheduled between Visit 1 and Visit 2.
- Planned participation in any other interventional clinical trial during 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 personal 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.
- Thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group 1: Primed
Group 2: Naive/Inadequately Primed
Arm Description
Have received 2 or more lifetime Flu Vaccinations Prior to Visit 1
Never Received or Received Only 1 Lifetime Flu Vaccination Prior to Visit 1
Outcomes
Primary Outcome Measures
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1
Solicited local reactions: Tenderness, pain, erythema, and swelling. Systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability, headache, malaise, and myalgia.
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2
Solicited local reactions: Tenderness, pain, erythema, and swelling. Systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability, headache, malaise, and myalgia.
Secondary Outcome Measures
Full Information
NCT ID
NCT00755274
First Posted
September 16, 2008
Last Updated
April 12, 2016
Sponsor
Sanofi Pasteur, a Sanofi Company
1. Study Identification
Unique Protocol Identification Number
NCT00755274
Brief Title
Annual Study for Serum Collection for Immunogenicity and Safety Evaluation in Healthy Children Receiving Fluzone®
Official Title
Annual Study for Serum Collection and Evaluation of Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Influenza Virus Vaccine (2008-2009 Formulation)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (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
Primary Objective:
To provide the Center for Biologics Evaluation and Research (CBER) with sera collected from healthy children receiving the 2008-2009 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study.
Observational Objectives:
To describe the safety of the 2008-2009 pediatric formulation of Fluzone® vaccine, administered in a one- or two-dose schedule in accordance with Advisory Committee on Immunization Practices (ACIP) recommendations, in children ≥ 6 months to < 5 years of age.
To describe the immunogenicity of the 2008-2009 pediatric formulation of Fluzone® vaccine, administered in a one- or two-dose schedule in accordance with ACIP recommendations, in children ≥ 6 months to < 5 years of age.
Detailed Description
The Advisory Committee on Immunization Practices (ACIP) has in recent years recommended that all healthy children aged 6 through 59 months receive influenza vaccine. Because of the growing emphasis on influenza immunization of infants and young children, Center for Biologics Evaluation and Research (CBER) has expressed interest in receiving sera from children who have been vaccinated with the current formulation of Fluzone® vaccine. These sera will be tested to evaluate each individual's immune response to the current formulation of Fluzone® vaccine and will also be used to evaluate circulating influenza strains in order to support formulation recommendations for the subsequent year (particularly for influenza B strains, which predominantly affect the young).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Orthomyxoviridae Infections
Keywords
Influenza, Orthomyxoviruses, Orthomyxoviridae Infections, Influenza vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1: Primed
Arm Type
Experimental
Arm Description
Have received 2 or more lifetime Flu Vaccinations Prior to Visit 1
Arm Title
Group 2: Naive/Inadequately Primed
Arm Type
Experimental
Arm Description
Never Received or Received Only 1 Lifetime Flu Vaccination Prior to Visit 1
Intervention Type
Biological
Intervention Name(s)
Influenza Virus Vaccine No Preservative: Pediatric Dose
Other Intervention Name(s)
Fluzone®
Intervention Description
0.25 mL, IM (age 6-35 months) or 0.5 mL, IM (age 36-59 months)
Intervention Type
Biological
Intervention Name(s)
Influenza Virus Vaccine No Preservative: Pediatric Dose
Other Intervention Name(s)
Fluzone®
Intervention Description
0.25 mL, IM (age 6-35 months) or 0.5 mL, IM (age 36-59 months)
Primary Outcome Measure Information:
Title
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1
Description
Solicited local reactions: Tenderness, pain, erythema, and swelling. Systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability, headache, malaise, and myalgia.
Time Frame
Day 0 to Day 3 post-vaccination 1
Title
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2
Description
Solicited local reactions: Tenderness, pain, erythema, and swelling. Systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability, headache, malaise, and myalgia.
Time Frame
Day 0 to Day 3 post-vaccination 2
Other Pre-specified Outcome Measures:
Title
Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination
Time Frame
Day 28 post-single dose or Day 21 post-Dose 2
Title
Percentage of Participants With Influenza Titers ≥ 1:40 After Fluzone® Vaccination (Seroprotection)
Description
Seroprotection was defined as a post-vaccination Hemagglutination inhibition titer ≥ 1:40. Data presented for all participants and those enrolled at age 6 to 35 months.
Time Frame
Day 28 post-single dose or Day 21 post-Dose 2
Title
Percentage of Participants With Influenza Titers ≥ 1:40 After Fluzone® Vaccination (Seroprotection)
Description
Seroprotection was defined as a post-vaccination Hemagglutination inhibition titer ≥ 1:40. Data presented for participants enrolled at age 36 to 59 months.
Time Frame
Day 28 post-single dose or Day 21 post-Dose 2
Title
Percentage of Participants With at Least a 4-Fold Rise in Influenza Titers After Fluzone® Vaccination (Seroconversion)
Description
Seroconversion was defined as a ≥ 4-fold increase in post-vaccination Hemagglutination inhibition titer. Data presented for all participants and those enrolled at age 6 to 35 months of age.
Time Frame
Day 28 post-single dose or Day 21 post-Dose 2
Title
Percentage of Participants With at Least a 4-Fold Rise in Influenza Titers After Fluzone® Vaccination (Seroconversion)
Description
Seroconversion was defined as a ≥ 4-fold increase in post-vaccination Hemagglutination inhibition titer. Data presented for participants enrolled at age 36 to 59 months.
Time Frame
Day 28 post-single dose or Day 21 post-Dose 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Participant is ≥ 6 months to < 5 years of age.
Participant is considered to be in good health on the basis of reported medical history and a limited history-directed physical examination.
Parent/legal acceptable representative is willing and able to bring the subject to the scheduled visits and to comply with the study procedures during the entire duration of the study.
Parent/legal acceptable representative is willing and able to provide informed consent.
Subject was born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg (5.5 lbs).
Exclusion Criteria:
Reported allergy to egg proteins, chicken proteins, or any other constituent of the vaccine.
History of severe adverse event to any influenza vaccine.
Laboratory-confirmed influenza infection or vaccination against influenza in the 6 months preceding enrollment in the study.
Any vaccination scheduled between Visit 1 and Visit 2.
Planned participation in any other interventional clinical trial during 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 personal 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.
Thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination.
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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Annual Study for Serum Collection for Immunogenicity and Safety Evaluation in Healthy Children Receiving Fluzone®
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