A Study to Evaluate the Safety and Tolerability of Trivalent Influenza Virus Vaccine in Children Aged 5 Years to < 9 Years

Seqirus

Status and phase: Completed; Phase 4

Conditions: Influenza, Human

Treatments: Biological: bioCSL Trivalent Influenza Virus Vaccine (CSL TIV); Biological: Comparator Quadrivalent Influenza Virus Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02212106

CSLCT-USF-10-69

2015-000175-27 (EudraCT Number)

Details and patient eligibility

About

This is a study to assess the safety of a bioCSL split virion, inactivated Trivalent Influenza Virus vaccine containing the 2014/2015 Northern Hemisphere strains of vaccine in children aged 5 years to less than 9 years. Comparison will be made to a licensed Quadrivalent Influenza Virus vaccine that complies with the FDA recommendations for the 2014/2015 influenza season in the US.

Enrollment: 402 patients

Sex: All

Ages: 5 to 8 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Males or females aged 5 to less than 9 years at the time of first study vaccination.
• The subject's parent or guardian to provide written informed consent and be willing and able to adhere to all protocol requirements.
• In good health, as determined by medical history and a targeted physical examination (if warranted).

Exclusion criteria

• Known hypersensitivity to a previous dose of Influenza Virus Vaccine or allergy to eggs or any components of the study vaccines.
• Clinical signs of significant active infection or an elevated oral temperature at study entry.
• A clinically significant medical or psychiatric condition.
• A history of seizures or febrile convulsions or Guillain-Barré syndrome.
• Vaccination with a seasonal or experimental influenza virus vaccine in the 6 months preceding study entry.
• Vaccination with a licensed vaccine within 14 days preceding study entry, or planning to be vaccinated with another licensed vaccine before the study exit evaluation.
• Currently receiving systemic glucocorticoid therapy (excluding intra-articular, topical or inhaled preparations) or have received such therapy within the 3 months preceding study entry.
• Currently receiving immunoglobulins and/or any blood products or have received such treatment within the 3 months preceding the administration of the study vaccine.
• Currently receiving treatment with warfarin or other anticoagulants.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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402 participants in 2 patient groups

bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)

Experimental group

Description:

The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).

Treatment:

Biological: bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)

Comparator Quadrivalent Influenza Virus Vaccine

Active Comparator group

Description:

The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.

Treatment:

Biological: Comparator Quadrivalent Influenza Virus Vaccine