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

Seqirus

Status and phase: Completed; Phase 3

Conditions: Influenza

Treatments: Biological: Influenza Virus Vaccine (Fluzone); Biological: CSL's Influenza Virus Vaccine (Afluria)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00959049

CSLCT-USF-07-36

Details and patient eligibility

About

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.

Enrollment: 1,474 patients

Sex: All

Ages: 6 months to 17 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,474 participants in 6 patient groups

Afluria Cohort A

Experimental group

Description:

Age 6 months to \< 3 years

Treatment:

Biological: CSL's Influenza Virus Vaccine (Afluria)

Afluria Cohort B

Experimental group

Description:

Age 3 to \< 9 years

Treatment:

Biological: CSL's Influenza Virus Vaccine (Afluria)

Afluria Cohort C

Experimental group

Description:

Age 9 to \< 18 years

Treatment:

Biological: CSL's Influenza Virus Vaccine (Afluria)

Fluzone Cohort A

Active Comparator group

Description:

Age 6 months to \< 3 years

Treatment:

Biological: Influenza Virus Vaccine (Fluzone)

Fluzone Cohort B

Active Comparator group

Description:

Age 3 to \< 9 years

Treatment:

Biological: Influenza Virus Vaccine (Fluzone)

Fluzone Cohort C

Active Comparator group

Description:

Age 9 to \< 18 years

Treatment:

Biological: Influenza Virus Vaccine (Fluzone)