NCT02222870

Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Quadrivalent, Influenza Vaccine

Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Quadrivalent, Influenza Vaccine (2014-2015 Formulation)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 6 Months – 8 Years
• Healthy volunteers: Accepted

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 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.

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 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.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Fluzone® Quadrivalent Influenza Vaccine, No Preservative	0.25 mL, Intramuscular (Pediatric Dose, 2014-2015 formulation)
BIOLOGICAL	Fluzone® Quadrivalent Influenza Vaccine, No Preservative	0.5 mL, Intramuscular (2014-2015 formulation)

Timeline

• Start date: 2014-08-01
• Primary completion: 2014-12-01
• Completion: 2015-06-01
• First posted: 2014-08-21
• Last updated: 2015-10-19
• Results posted: 2015-10-19

Locations

2 sites across 1 country: United States