Study of Quadrivalent Influenza Vaccine Among Adults

Phase 3

Completed

• Conditions: Influenza
• Interventions: Biological: Investigational Quadrivalent Inactivated Influenza Vaccine, No Preservative; Biological: Investigational Trivalent Inactivated Influenza Vaccine, No Preservative

• Registration Number: NCT01218646
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

The aim of the study is to evaluate a prototype quadrivalent influenza vaccine (QIV), the licensed 2010-2011 trivalent influenza vaccine (TIV) containing the primary B strain, and the investigational TIV containing the alternate B strain in adult subjects.

Primary Objective:

* To demonstrate non-inferiority of antibody responses to QIV compared with licensed 2010-2011 TIV (containing the primary B strain) and investigational TIV (containing the alternate B strain) as assessed by geometric mean titer (GMT) ratios for each of the four virus strains separately among subjects 65 years of age and older

Observational Objective:

* To describe the safety profiles of TIV among subjects 18 years of age and older and QIV in subjects 65 years and older, as assessed by solicited injection site and systemic adverse events (AEs) collected for 7 days post-vaccination, unsolicited adverse events collected from 21 days post-vaccination, and adverse events of special interest and serious adverse events (SAEs) collected from Visit 1 to Visit 2.

Detailed Description

All participants will receive a single dose of their assigned vaccine during Visit 1. They will be followed up for safety and immunogenicity through Day 21 post-vaccination (Visit 2)

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-08
• Study First Submitted QC: 2010-10-08
• Study First Posted: 2010-10-11
• Primary Completion: 2011-03
• Study Completion: 2011-04
• Disposition First Submitted: 2011-12-12
• Disposition First Submitted QC: 2011-12-12
• Disposition First Posted: 2011-12-22
• Results First Submitted: 2013-07-03
• Results First Submitted QC: 2013-07-03
• Status Verified: 2013-09
• Results First Posted: 2013-09-12
• Last Update Submitted: 2013-09-13
• Last Update Posted: 2013-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 739

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: Investigational Quadrivalent Influenza Vaccine	Investigational Quadrivalent Inactivated Influenza Vaccine, No Preservative	Participants will receive a dose of Investigational Quadrivalent Inactivated Influenza Vaccine
Group 2: Investigational Trivalent Influenza Vaccine	Investigational Trivalent Inactivated Influenza Vaccine, No Preservative	Participants will receive a dose of Investigational Trivalent Inactivated Influenza Vaccine

Primary Outcome Measures

Name	Time	Method
Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or After Trivalent Influenza Vaccines Without Corresponding B Strain in Participants Aged 65 Years and Older.	Day 21 post-vaccination	Immunogenicity outcomes were assessed in serum samples by 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 Against the Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines (TIV) in Participants Aged 18 Years or Older	Day 0 and Day 21 post-vaccination	Immunogenicity outcomes were assessed in serum samples by 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 Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines With Corresponding B Strain in Participants Aged 65 Years and Older.	Day 21 post-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.