Clinical Study to Evaluate Safety, Immunogenicity of Investigational Flu Vaccine Compared to an Approved Flu Vaccine (QIV) in Children Previously Vaccinated in Trial V118_05

Seqirus

Status and phase: Completed; Phase 3

Conditions: Influenza

Treatments: Biological: non-adjuvanted Quadrivalent Influenza Vaccine (QIV); Biological: Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02255409

V118_05E1

2014-002599-95 (EudraCT Number)

Details and patient eligibility

About

Safety, Immunogenicity of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children Previously Vaccinated in Trial V118_05

Enrollment: 607 patients

Sex: All

Ages: 12 to 84 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Male or female subject who has completed their Day 181 clinic visit for non-naïve subjects or their Day 209 clinic visit for naïve subjects in parent study.
2. Individuals who give written informed consent, who can comply with study procedures, and who are available for follow-up

Exclusion criteria

1. Individuals recently vaccinated against influenza.
2. Subjects with contraindications to receive influenza vaccine.
3. Please contact the site for additional eligibility criteria.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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607 participants in 2 patient groups

aQIV

Experimental group

Description:

Adjuvanted Quadrivalent Subunit Influenza

Treatment:

Biological: Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

QIV

Active Comparator group

Description:

Non-Adjuvanted Quadrivalent Subunit Influenza

Treatment:

Biological: non-adjuvanted Quadrivalent Influenza Vaccine (QIV)