Study of Safety and Immunogenicity of Fluzone® in Healthy Children

Phase 4

Completed

• Conditions: Influenza
• Interventions: Biological: Influenza Vaccine 2004-2005 Paediatric Formulation

• Registration Number: NCT00831675
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

To describe the safety of the 2004-2005 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to \< 36 months.

To describe the immunogenicity of the 2004-2005 inactivated, split-virion influenza vaccine Fluzone®, administered in a two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to \< 36 months

Detailed Description

To provide the Centers for Biologic Evaluation and Research (CBER) with sera collected from healthy children receiving the 2004-2005 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study by the Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), and the World Health Organization (WHO).

Study Timeline

• Study Start: 2004-09
• Primary Completion: 2006-04
• Study Completion: 2006-04
• Study First Submitted: 2009-01-28
• Study First Submitted QC: 2009-01-28
• Study First Posted: 2009-01-29
• Results First Submitted: 2009-07-20
• Results First Submitted QC: 2009-07-20
• Results First Posted: 2009-08-27
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-12
• Last Update Posted: 2016-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Infants <12 Months	Influenza Vaccine 2004-2005 Paediatric Formulation	Participants aged ≥ 6 to \< 12 months at enrollment and received 2 doses of Fluzone® Vaccine
Toddlers ≥12 Months	Influenza Vaccine 2004-2005 Paediatric Formulation	Participants aged ≥ 12 to \< 36 months at enrollment and received 2 doses of Fluzone® vaccine

Primary Outcome Measures

Name	Time	Method
Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation	Days 0-3 Post-dose	Solicited local reactions: Erythema, bruising, induration, pain at injection site.; Solicited systemic reactions: Fever (temperature), irritability, crying, lethargy, appetite decreased, diarrhea, vomiting, rash collected daily for four days after each injection.