Back to resultsPhase IV Trial to Collect Safety Data and Sera for Immunogenicity Testing in Healthy Children Given Fluzone® Vaccine
Primary Purpose
Influenza
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
2007-2008 Influenza Virus Vaccine
2007-2008 Influenza Virus Vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring Influenza Vaccine, Influenza Virus, Orthomyxoviridae Infections, Fluzone®
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 (5.5 lbs).
Exclusion Criteria:
- Reported allergy to egg proteins, chicken proteins, or any other constituent of the vaccine.
- An acute illness with or without fever (For infants/toddlers: temperature ≥ 100.4°F rectal; For children: temperature ≥ 99.5°F oral/axillary) 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 or planned 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.
- Received any vaccinations within the preceding 14 days (enrollment may be deferred).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Influenza vaccine Naive/Inadequately Primed
Influenza Vaccine Primed
Arm Description
Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of Fluzone®, on Days 0 and 14.
Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of Fluzone® on Day 0.
Outcomes
Primary Outcome Measures
Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation
Solicited injection site reactions: Erythema, swelling, pain/tenderness; Solicited systemic reactions: (for infants/toddlers) - fever, irritability, abnormal crying, drowsiness, lost appetite, vomiting; (for children) - fever, headache, malaise, myalgia) Note: Influenza-primed group received only dose 1.
Secondary Outcome Measures
Full Information
NCT ID
NCT00561002
First Posted
November 19, 2007
Last Updated
April 12, 2016
Sponsor
Sanofi Pasteur, a Sanofi Company
1. Study Identification
Unique Protocol Identification Number
NCT00561002
Brief Title
Phase IV Trial to Collect Safety Data and Sera for Immunogenicity Testing 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 (2007-2008 Formulation)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
June 2008 (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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza Vaccine, Influenza Virus, Orthomyxoviridae Infections, Fluzone®
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Influenza vaccine Naive/Inadequately Primed
Arm Type
Experimental
Arm Description
Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of Fluzone®, on Days 0 and 14.
Arm Title
Influenza Vaccine Primed
Arm Type
Experimental
Arm Description
Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of Fluzone® on Day 0.
Intervention Type
Biological
Intervention Name(s)
2007-2008 Influenza Virus Vaccine
Other Intervention Name(s)
Fluzone®
Intervention Description
0.25 mL, Intramuscular
Intervention Type
Biological
Intervention Name(s)
2007-2008 Influenza Virus Vaccine
Other Intervention Name(s)
Fluzone®
Intervention Description
0.25 mL, Intramuscular
Primary Outcome Measure Information:
Title
Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation
Description
Solicited injection site reactions: Erythema, swelling, pain/tenderness; Solicited systemic reactions: (for infants/toddlers) - fever, irritability, abnormal crying, drowsiness, lost appetite, vomiting; (for children) - fever, headache, malaise, myalgia) Note: Influenza-primed group received only dose 1.
Time Frame
Days 0-3 post-dose
Other Pre-specified Outcome Measures:
Title
Geometric Mean Titers (GMTs) of Hemagglutinin Antibodies Pre- and Post-Fluzone® Vaccination
Time Frame
Day 0 and Day 14 after last dose of Fluzone
Title
Percentage of Participants With at Least a 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroprotection)
Description
Seroprotection was defined as a serum hemagglutination inhibition antibody titer ≥40.
Time Frame
Day 14 post-vaccination
Title
Seroconversion Rates for Each Influenza Antigen Post-Vaccination
Description
Seroconversion was defined as a post-vaccination titer ≥ 40 for participants with a titer < 10 on Day 0 and a ≥4-fold increase for participants with a titer ≥ 10 on Day 0.
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
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 (5.5 lbs).
Exclusion Criteria:
Reported allergy to egg proteins, chicken proteins, or any other constituent of the vaccine.
An acute illness with or without fever (For infants/toddlers: temperature ≥ 100.4°F rectal; For children: temperature ≥ 99.5°F oral/axillary) 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 or planned 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.
Received any vaccinations within the preceding 14 days (enrollment may be deferred).
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
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.sanofipasteur.com
Description
Related Info
Learn more about this trial
Phase IV Trial to Collect Safety Data and Sera for Immunogenicity Testing in Healthy Children Given Fluzone® Vaccine
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