Safety and Immunogenicity Testing of Influenza Vaccine in Healthy Children 2 Months and 6 Months of Age

Phase 1

Completed

• Conditions: Influenza
• Interventions: Biological: Influenza virus vaccine (2004-2005 Formulation)

• Registration Number: NCT00858468
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

Primary Objective:

To describe the safety of the 2004-2005 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in the two-dose schedule (described in the package insert for vaccine-naïve young children) to the investigational and control groups.

Observational Objective:

To describe the percentage of protective Hemagglutination Inhibition (HAI) antibody titers (following a 2-dose Fluzone® immunization series) to each of the 3 vaccine antigens among the investigational and control groups.

Detailed Description

This is an observational and descriptive study that will provide preliminary comparative information about the safety and immunogenicity of Fluzone® vaccine among children aged 6 to 12 weeks (the investigational group, also referred to as the 2-month-old group) versus children aged 24 to 36 weeks (the control group, also referred to as the 6-month-old group). The study is not designed to achieve any preset statistical power, and no hypotheses will be tested.

Study Timeline

• Study Start: 2005-04
• Primary Completion: 2006-06
• Study Completion: 2006-12
• Study First Submitted: 2009-03-05
• Study First Submitted QC: 2009-03-05
• Study First Posted: 2009-03-09
• Results First Submitted: 2009-04-20
• Results First Submitted QC: 2009-06-09
• Results First Posted: 2009-07-31
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-12
• Last Update Posted: 2016-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 394

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	Influenza virus vaccine (2004-2005 Formulation)	Participants aged 24 to 36 Weeks at enrollment
Group 1	Influenza virus vaccine (2004-2005 Formulation)	Participants aged 6 to 12 Weeks at enrollment

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation.	Day 0 to Day 7 post-vaccination	Solicited local (injection site) reactions: Tenderness, erythema (redness), and swelling Solicited systemic reactions: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Loss of Appetite, and Irritability.