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 on Immunization Practices (ACIP) recommendations, in children 6 months to \< 9 years of age. Objective: * To describe the safety of the 2014-2015 formulation of Fluzone Quadrivalent vaccine, administered in a 1- or 2-dose schedule, in accordance with ACIP recommendations, in children 6 months to \< 9 years of age. Observational objectives: * To describe the immunogenicity of the 2014-2015 formulation of Fluzone Quadrivalent 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 available sera from each subject to Center for Biologics Evaluation and Research (CBER) for further analysis by the WHO, the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) to support formulation recommendations for subsequent influenza vaccines.
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 influenza vaccine are recommended per ACIP guidance, will receive a second dose during Visit 2 (28 days after Visit 1). Solicited adverse event (AE) information will be collected for 7 days after each vaccination, unsolicited AE information will be collected from Visit 1 to Visit 2, or to Visit 3 for those subjects receiving 2 doses. Serious adverse event (SAE) information will be collected the study. Immunogenicity will be evaluated in all participants prior to vaccination and at Day 28 after the final vaccination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
60
0.25 mL, Intramuscular (Pediatric Dose, 2014-2015 formulation)
0.5 mL, Intramuscular (2014-2015 formulation)
Unnamed facility
Bardstown, Kentucky, United States
Unnamed facility
Salt Lake City, Utah, United States
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine
Solicited Injection-site: 6 to \< 36 months - Tenderness, Erythema, and Swelling; 3 to \< 9 years - Pain, Erythema, and Swelling. Solicited systemic reactions: 6 to \< 36 months - Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability; 3 to \< 9 years - Fever, Headache, Malaise, and Myalgia. Grade 3: Fever, \> 39.5˚C (6 to \< 36 months), ≥ 39.0˚C (3 to \< 9 years); Vomiting, ≥ 6 episodes/24 hours or requires parenteral hydration; Crying abnormal, \> 3 hours; Drowsiness, Sleeping often/difficult to wake; Appetite lost, Refuses ≥ 3 or most meals; Irritability, Inconsolable; Headache, Malaise, and Myalgia, Significant, prevents daily activity.
Time frame: Day 0 up to Day 7 post-any injection
Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Post Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine
Geometric titers of influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay.
Time frame: Day 0 (pre-vaccination) and Day 28 post-final vaccination
Number of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine
Influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay. Seroprotection was defined as a titer ≥ 40 (l/dil) at pre-vaccination and at 28 days after the final vaccination.
Time frame: Day 0 (pre-vaccination) and Day 28 post-final vaccination
Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine
Influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay. Seroconversion is defined as either a pre-vaccination HAI titer \< 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination titer.
Time frame: Day 28 post-final vaccination
Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine
Geometric titer ratios of influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay.
Time frame: Day 28 post-final vaccination
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.