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

Seqirus1,474 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

1,474

Conditions

Influenza

Interventions

CSL's Influenza Virus Vaccine (Afluria)BIOLOGICAL

0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines

Influenza Virus Vaccine (Fluzone)BIOLOGICAL

0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 17 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (23)

Unnamed facility

Chandler, Arizona, United States

Unnamed facility

Harrisburg, Arkansas, United States

Outcomes

Primary Outcomes

Geometric Mean Titer 30 Days After the Last Study Vaccination

Time frame: 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.

Time frame: 30 days after the last study vaccination

Secondary Outcomes

Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)

Time frame: 7 days after each vaccination

Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B

Time frame: 7 days after each vaccination

Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C

Time frame: 7 days after vaccination

Frequency and Intensity of Unsolicited Adverse Events (UAEs)

UAE stands for Unsolicited Adverse Events

Time frame: 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).

Time frame: 6 months after last study vaccination

Data from ClinicalTrials.gov

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