A Study to Determine the Immunogenicity and Safety Profile of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Comparator Influenza Virus Vaccine in a Pediatric Population

A Phase III, Randomized, Observer-blind, Multi-center, Noninferiority Comparison of the Immune Response of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Trivalent Inactivated Split-Virion Influenza Vaccine in a Pediatric Population Aged Greater Than or Equal to 6 Months to Less Than 18 Years.

The purpose of this study is to determine the immunogenicity and safety profile of CSL Limited's Influenza Virus Vaccine compared to a US licensed comparator Influenza Virus Vaccine in a pediatric population aged greater than or equal to 6 months to less than 18 years.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: CSL's Influenza Virus Vaccine (Afluria); Biological: Influenza Virus Vaccine (Fluzone)

• Study Type: Interventional
• Enrollment (Actual): 1474
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
  • Arkansas
    • Harrisburg, Arkansas, United States, 72432
    • Jonesboro, Arkansas, United States, 72401
    • Little Rock, Arkansas, United States, 72205
    • Mountain Home, Arkansas, United States, 72653
  • Florida
    • Melbourne, Florida, United States, 32935
  • Kentucky
    • Bardstown, Kentucky, United States, 40004
  • Nebraska
    • Omaha, Nebraska, United States, 68134
  • New York
    • Binghamton, New York, United States, 13901
    • Elmira, New York, United States, 14901
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center- Division of Infectious Disease
  • Oklahoma
    • Warr Acres, Oklahoma, United States, 73132
  • Pennsylvania
    • Greenville, Pennsylvania, United States, 16125
      • UPMC / Community Medicine Inc
    • Latrobe, Pennsylvania, United States, 15650
      • Pediatric Associates of Latrobe
    • Pittsburgh, Pennsylvania, United States, 15241
    • Pittsburgh, Pennsylvania, United States, 15227
      • South Hills Pediatrics
    • Pittsburgh, Pennsylvania, United States, 15220
      • Pediatric Alliance Greentree Division
  • Utah
    • Salt Lake City, Utah, United States, 84121
    • Salt Lake City, Utah, United States, 84109
    • Salt Lake City, Utah, United States, 84124
    • South Jordan, Utah, United States, 84095
  • Virginia
    • Burke, Virginia, United States, 22015
    • Vienna, Virginia, United States, 22180

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy male or non-pregnant female participants aged ≥ 6 calendar months to < 18 years at the time of the first study vaccination.
• For participants aged ≥ 6 months to < 9 years, born after a normal gestation period (between 36 and 42 weeks).
• Females of childbearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for at least 2 months after vaccination. Females aged ≥ 9 years must also return a negative urine pregnancy test at enrollment.

Exclusion Criteria:

• Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Study Vaccine.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Afluria Cohort A; Age 6 months to < 3 years	Biological: CSL's Influenza Virus Vaccine (Afluria); 0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines
Experimental: Afluria Cohort B; Age 3 to < 9 years	Biological: CSL's Influenza Virus Vaccine (Afluria); 0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines
Experimental: Afluria Cohort C; Age 9 to < 18 years	Biological: CSL's Influenza Virus Vaccine (Afluria); 0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines
Active Comparator: Fluzone Cohort A; Age 6 months to < 3 years	Biological: Influenza Virus Vaccine (Fluzone); 0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines
Active Comparator: Fluzone Cohort B; Age 3 to < 9 years	Biological: Influenza Virus Vaccine (Fluzone); 0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines
Active Comparator: Fluzone Cohort C; Age 9 to < 18 years	Biological: Influenza Virus Vaccine (Fluzone); 0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric Mean Titer 30 Days After the Last Study Vaccination		30 days after the last study vaccination
Percentage of Participants With Seroconversion 30 Days After the Last Study Vaccination	Seroconversion rate was defined as the proportion of participants with either a titer of less than 1:10 before vaccination achieving a HI antibody titer of 1:40 or more after vaccination, or a HI titer of 1:10 or more before vaccination achieving a four-fold or greater increase in HI titer after vaccination.	30 days after the last study vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)		7 days after each vaccination
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B		7 days after each vaccination
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C		7 days after vaccination
Frequency and Intensity of Unsolicited Adverse Events (UAEs)	UAE stands for Unsolicited Adverse Events	30 days after each vaccination
New Onset of Chronic Illnesses (NOCIs)	New onset of chronic illness after any vaccine dose. A new onset of chronic illness was defined as the diagnosis of a new medical condition which was chronic in nature, including those potentially controllable by medication (e.g., diabetes, asthma).	6 months after last study vaccination
Serious Adverse Events (SAEs)		6 months after last study vaccination
Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)		7 days after each vaccination
Duration of Local and Systemic Solicited Symptoms, Cohort B		7 days after each vaccination
Duration of Local and Systemic Solicited Symptoms, Cohort C		7 days after vaccination

Collaborators and Investigators

• Sponsor: Seqirus
• Investigators: Study Director: Clinical Director Vaccines, Seqirus

Publications and helpful links

General Publications

• Brady RC, Hu W, Houchin VG, Eder FS, Jackson KC, Hartel GF, Sawlwin DC, Albano FR, Greenberg M. Randomized trial to compare the safety and immunogenicity of CSL Limited's 2009 trivalent inactivated influenza vaccine to an established vaccine in United States children. Vaccine. 2014 Dec 12;32(52):7141-7. doi: 10.1016/j.vaccine.2014.10.024. Epub 2014 Oct 29.

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: August 12, 2009
• First Submitted That Met QC Criteria: August 13, 2009
• First Posted (Estimate): August 14, 2009

Study Record Updates

• Last Update Posted (Actual): May 16, 2017
• Last Update Submitted That Met QC Criteria: April 16, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: CSLCT-USF-07-36