Status:
COMPLETED
Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Quadrivalent, Influenza Vaccine
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Influenza
Eligibility:
All Genders
6-8 years
Phase:
PHASE4
Brief Summary
The study will evaluate the safety and immunogenicity of the 2014-2015 formulation of Fluzone Quadrivalent vaccine, administered in a 1- or 2-dose schedule, in accordance with the Advisory Committee o...
Detailed Description
Participants will be assigned to the appropriate age group based on the age at the time of enrollment. Participants will receive a dose of Fluzone Quadrivalent vaccine, those for whom 2 doses of influ...
Eligibility Criteria
Inclusion
- Subject is 6 months to \< 9 years of age on the day of first study vaccination (study product administration)
- Subject and parent/legally acceptable representative are 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 \< 9 years of age.
- For subjects 6 months to \< 12 months of age, born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg (5.5 lbs).
Exclusion
- Known systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components, or a history of a life-threatening reaction to Fluzone Quadrivalent 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 dose of 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 2014-2015 influenza vaccine.
- Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, which may be a contraindication for intramuscular vaccination, at the discretion of the Investigator.
- Thrombocytopenia, which may be a contraindication for intramuscular 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, 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.
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT02222870
Start Date
August 1 2014
End Date
June 1 2015
Last Update
October 19 2015
Active Locations (2)
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1
Bardstown, Kentucky, United States, 40040
2
Salt Lake City, Utah, United States, 84121