Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Influenza Virus Vaccine (2012-2013 Formulation)
2 other identifiers
interventional
60
1 country
2
Brief Summary
The aim of this clinical study is to demonstrate safety and immunogenicity of Fluzone vaccine. Objective:
- To describe the safety of the 2012-2013 formulation of Fluzone vaccine, administered in a 1- or 2-dose schedule, in accordance with Advisory Committee on Immunization Practices (ACIP) recommendations, in children 6 months to \< 9 years of age. Observational Objectives:
- To describe the immunogenicity of the 2012-2013 formulation of Fluzone vaccine, administered in a 1- or 2-dose schedule in accordance with ACIP recommendations, in children 6 months to \< 9 years of age.
- To submit remaining available sera from subjects to the Center for Biologics Evaluation and Research (CBER) for further analysis by the World Health Organization (WHO), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) to support selection and recommendation of strains for subsequent years' influenza vaccines.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Sep 2012
Shorter than P25 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 19, 2012
CompletedFirst Posted
Study publicly available on registry
September 24, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedResults Posted
Study results publicly available
April 16, 2014
CompletedApril 16, 2014
March 1, 2014
3 months
September 19, 2012
January 24, 2014
March 12, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation)
Solicited injection site reactions (Age 6 to \< 24 Months): Tenderness, Erythema and Swelling. Solicited systemic reactions: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability. Grade 3: Tenderness, Cries when injected limb is moved; Erythema and Swelling, ≥ 50 mm; Fever, \>103.1°F; Vomiting, ≥6 episodes/24 hours; Abnormal crying, \>3 hours; Drowsiness, Sleeping most of the time; Loss of appetite, Refuses ≥3 feeds/meals or most feeds/meals; Irritability, Inconsolable. Solicited injection site reactions (Age 24 Months to \< 9 Years): Pain, Erythema, and Swelling. Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3: Pain, Incapacitating, unable to perform usual activities; Redness and Swelling, ≥ 50 mm; Fever: ≥102.1°F; Headache, Malaise, and Myalgia, Significant, prevents daily activity.
Day 0 up to Day 7 post-vaccination
Other Outcomes (4)
Geometric Mean Titers of Antibodies to Influenza Antigens Before and Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation).
Day 0 (pre-vaccination) and Day 28 after final vaccination
Number of Participants With Seroprotection Before and Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation)
Day 0 (pre-vaccination) and Day 28 after final vaccination
Number of Participants With Seroconversion Against Influenza Virus Antigens Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation)
Day 28 after final vaccination
- +1 more other outcomes
Study Arms (2)
6 months to < 36 months of age group
EXPERIMENTALParticipants at 6 months to \< 36 months of age at the time of enrollment will receive Influenza Virus Vaccine, No Preservative; Fluzone® (Pediatric Dose).
3 years to < 9 years of age group
EXPERIMENTALParticipants at 3 years to \< 9 years of age at the time of enrollment will receive Influenza Virus Vaccine, No Preservative; Fluzone®.
Interventions
0.25 mL dose, Intramuscular
0.5 mL dose, Intramuscular
Eligibility Criteria
You may qualify if:
- Parent/guardian is willing and able to attend scheduled visits and to comply with the study procedures during the entire duration of the study
- Assent form has been signed and dated by subjects 7 to \< 9 years of age, and informed consent form has been signed and dated by parent(s) or another legally acceptable representative
- For subjects 6 months to \< 24 months of age, born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg (5.5 lbs).
You may not qualify if:
- Known systemic hypersensitivity to eggs, chicken proteins, latex, or any of the vaccine components, or a history of a life-threatening reaction to Fluzone vaccine or to a vaccine containing any of the same substances (the complete list of vaccine components is included in the Prescribing Information)
- History of serious adverse reaction to any influenza vaccine
- Receipt of any vaccine within 30 days before receiving study vaccine, or plans to receive another vaccine before Visit 2 for subjects receiving 1 influenza vaccine or Visit 3 for subjects receiving 2 doses of influenza vaccine
- Participation in another interventional clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 30 days preceding the first study vaccination or during the course of the study unless no intervention for the other study occurred within the 30 days prior to the first study vaccination and none are planned before the subject would complete safety surveillance for the present study
- Prior vaccination with any formulation of 2012-2013 influenza vaccine
- Thrombocytopenia, which may be a contraindication for IM vaccination, at the discretion of the Investigator
- Any condition that in the opinion of the Investigator would pose a health risk to the subject if enrolled or could interfere with the evaluation of the vaccine
- Personal history of Guillain-Barré syndrome
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- Personal history of clinically significant developmental delay (at the discretion of the Investigator), neurologic disorder, or seizure disorder
- Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion
- Known seropositivity for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
- Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 100.4°F). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided
- Receipt of immune globulins, blood, or blood-derived products in the past 3 months
- Identified as a natural or adopted child of the Investigator or an employee with direct involvement in the proposed study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Unknown Facility
Bardstown, Kentucky, 40004, United States
Unknown Facility
Salt Lake City, Utah, 84124, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Sanofi Pasteur Inc.
Study Officials
- STUDY DIRECTOR
Medical Director
Sanofi Pasteur Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2012
First Posted
September 24, 2012
Study Start
September 1, 2012
Primary Completion
December 1, 2012
Study Completion
February 1, 2013
Last Updated
April 16, 2014
Results First Posted
April 16, 2014
Record last verified: 2014-03