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

Phase 3

Completed

• Conditions: Influenza
• Interventions: Biological: CSL's Influenza Virus Vaccine (Afluria); Biological: Influenza Virus Vaccine (Fluzone)

• Registration Number: NCT00959049
• Lead Sponsor: Seqirus

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-08-12
• Study First Submitted QC: 2009-08-13
• Study First Posted: 2009-08-14
• Study Start: 2009-09
• Primary Completion: 2009-12
• Study Completion: 2010-05
• Results First Submitted: 2011-07-03
• Results First Submitted QC: 2011-07-03
• Results First Posted: 2011-07-29
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-16
• Last Update Posted: 2017-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1474

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Afluria Cohort C	CSL's Influenza Virus Vaccine (Afluria)	Age 9 to \< 18 years
Fluzone Cohort A	Influenza Virus Vaccine (Fluzone)	Age 6 months to \< 3 years
Fluzone Cohort B	Influenza Virus Vaccine (Fluzone)	Age 3 to \< 9 years
Afluria Cohort A	CSL's Influenza Virus Vaccine (Afluria)	Age 6 months to \< 3 years
Afluria Cohort B	CSL's Influenza Virus Vaccine (Afluria)	Age 3 to \< 9 years
Fluzone Cohort C	Influenza Virus Vaccine (Fluzone)	Age 9 to \< 18 years

Primary Outcome Measures

Name	Time	Method
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	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.

Secondary Outcome Measures

Name	Time	Method
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 Unsolicited Adverse Events (UAEs)	30 days after each vaccination	UAE stands for Unsolicited Adverse Events
New Onset of Chronic Illnesses (NOCIs)	6 months after last study vaccination	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).
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B	7 days after each 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 C	7 days after vaccination
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C	7 days after vaccination
Serious Adverse Events (SAEs)	6 months after last study vaccination
Duration of Local and Systemic Solicited Symptoms, Cohort B	7 days after each vaccination

Trial Locations

Locations (5)

UPMC / Community Medicine Inc; 🇺🇸 Greenville, Pennsylvania, United States

Cincinnati Children's Hospital Medical Center- Division of Infectious Disease; 🇺🇸 Cincinnati, Ohio, United States

Pediatric Associates of Latrobe; 🇺🇸 Latrobe, Pennsylvania, United States

Pediatric Alliance Greentree Division; 🇺🇸 Pittsburgh, Pennsylvania, United States

South Hills Pediatrics; 🇺🇸 Pittsburgh, Pennsylvania, United States