Clinical Study to Evaluate the Safety, Immunogenicity and Efficacy of Investigational Flu Vaccine Compared to Approved Flu Vaccine in Children.

Seqirus

Status and phase: Completed; Phase 3

Conditions: Influenza Virus

Treatments: Biological: Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV); Biological: Non-adjuvanted Trivalent Influenza Vaccine (TIV) / Quadrivalent Influenza Vaccine (QIV)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01964989

2012-000218-12 (EudraCT Number)

V118_05

Details and patient eligibility

About

Safety, Immunogenicity and Efficacy of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children ≥6 to <72 Months of Age. The study was conducted during the 2013/2014 and 2014/2015 northern hemisphere influenza season.

Enrollment: 10,644 patients

Sex: All

Ages: 6 to 71 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Children, males and females, healthy or at high risk of complications from influenza, between ≥6 months to <72 months of age
• Documented consent provided by the subject's parent(s)/legal guardian(s)
• Subjects and/or subject's parent(s)/legal guardian(s) able to comply with all study procedures.

Exclusion criteria

• Children with history of allergy to vaccine components.
• Additional eligibility criteria may be discussed by contacting the site

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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10,644 participants in 2 patient groups

aQIV

Experimental group

Description:

flu vaccine

Treatment:

Biological: Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

non-adjuvanted comparator

Active Comparator group

Description:

flu vaccine

Treatment:

Biological: Non-adjuvanted Trivalent Influenza Vaccine (TIV) / Quadrivalent Influenza Vaccine (QIV)