A Study of Influenza Virus Vaccines in Children and Adults

Phase 2

Completed

• Conditions: Influenza
• Interventions: Biological: 2008-2009 Trivalent Influenza Virus Vaccine; Biological: Quadrivalent Influenza Virus Vaccine; Biological: 2009-2010 Trivalent Influenza Virus Vaccine

• Registration Number: NCT00988143
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

The purpose of this study is to describe the immunogenicity of the prototype Quadrivalent Influenza Vaccine (QIV) compared with the 2009-2010 Trivalent Influenza Vaccine (TIV) and the 2008-2009 TIV among children and adults.

Primary Objective:

To describe the immunogenicity of the prototype Quadrivalent Influenza Vaccine (QIV) compared with the 2009-2010 Trivalent Influenza Vaccine (TIV) and the 2008-2009 TIV among adults.

Observational Objectives:

* To describe the safety of the 2009-2010 TIV among subjects ≥6 months to \<5 years, 18-60 years, and ≥ 61 years of age, and to describe the safety of 2008-2009 TIV and prototype QIV Fluzone® vaccines among subjects 18-60 years and ≥ 61 years of age.

* To describe the immunogenicity of the 2009-2010 TIV vaccine among subjects ≥6 months to \<5 years, 18-60 years, and ≥61 years of age, and to describe the immunogenicity of 2008-2009 TIV and prototype QIV vaccines among subjects 18-60 years and ≥61 years of age.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-01
• Study First Submitted QC: 2009-10-01
• Study First Posted: 2009-10-02
• Primary Completion: 2009-12
• Study Completion: 2010-03
• Disposition First Submitted: 2011-01-03
• Disposition First Submitted QC: 2011-01-03
• Disposition First Posted: 2011-01-05
• Results First Submitted: 2013-07-03
• Status Verified: 2013-11
• Results First Submitted QC: 2013-11-18
• Last Update Submitted: 2013-11-18
• Results First Posted: 2013-12-12
• Last Update Posted: 2013-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Group 2	2008-2009 Trivalent Influenza Virus Vaccine	Participants will receive the 2008-2009 Trivalent Influenza Vaccine (TIV)
Study Group 3	Quadrivalent Influenza Virus Vaccine	Participants will receive the Quadrivalent Influenza Vaccine (QIV)
Study Group 1	2009-2010 Trivalent Influenza Virus Vaccine	Participants will receive the 2009-2010 Trivalent Influenza Vaccine (TIV) (Pediatric dose have no preservatives)

Primary Outcome Measures

Name	Time	Method
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines.	Day 0 up to 7 days post-vaccination	Solicited injection site reactions (6-23 Months): Tenderness, Redness and Swelling; Solicited systemic reactions: Fever, Abnormal crying, Drowsiness, Loss of appetite, Vomiting and Irritability Grade 3 Tenderness: cries when injected limb is moved; Redness and Swelling: ≥5 cm; Fever: \>103.1°F; Abnormal crying: \>3 hours; Drowsiness: Sleeping most of the time; Loss of appetite: refuses ≥3 feeds/meals; Vomiting: ≥6 episodes/24 hours; Irritability: inconsolable.; (24-59 Months): Pain, Redness and Swelling; Fever, Headache, Malaise and Myalgia. Grade 3: Pain, Incapacitating; Redness and Swelling: ≥5 cm; Fever: \>102.1°F, Headache, Malaise and Myalgia: Significant, prevents daily activity.; (Adults): Pain, Redness, Induration, and Ecchymosis; Fever, Headache, Malaise, Myalgia and Shivering.; Grade 3: Pain: significant, prevents daily activities; Redness, Swelling, Induration and Ecchymosis: \>10 cm; Fever \>102.1°F; Headache, Malaise, Myalgia \& Shivering: Significant, prevents daily activity.
Geometric Mean Titers (GMTs) Against Influenza A Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine in Adult Participants.	21 Days post last vaccination	Immunogenicity outcomes were assessed in serum samples by Hemagglutination inhibition (HAI) assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10.
Geometric Mean Titers (GMTs) Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine in Adult Participants.	21 Days post last vaccination	Immunogenicity outcomes were assessed in serum samples by Hemagglutination inhibition (HAI) assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10.