Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects

Seqirus

Status and phase: Completed; Phase 3

Conditions: Influenza; Virus Diseases; Human

Treatments: Biological: Comparator QIV; Biological: QIVc

Study type: Interventional

Funder types: Industry

Identifiers

NCT04074928

2020-002785-13 (EudraCT Number)

V130_10

Details and patient eligibility

About

This phase 3 clinical study is a randomized, observer-blind, comparator-controlled, multicenter study of QIVc versus a US-licensed comparator QIV in children 6 months through 47 months of age. The purpose of this study is to demonstrate that vaccination with QIVc elicits an immune response that is noninferior to that of a US-licensed comparator QIV containing the same virus strains, in children 6 months through 47 months of age.

Enrollment: 2,414 patients

Sex: All

Ages: 6 to 47 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Individuals of 6 through 47 months of age on the day of informed consent.
• Individuals whose parent(s)/Legally Acceptable Representative (LAR) have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
• Individuals who can comply with study procedures including follow-up
• Individual is in generally good health as per the Investigator's medical judgement

Exclusion criteria

• Acute (severe) febrile illness
• History of any anaphylaxis, serious vaccine reactions or hypersensitivity, including allergic reactions, to any component of vaccine or medical equipment whose use is foreseen in this study
• A known history of Guillain-Barre Syndrome or other demyelinating diseases such as encephalomyelitis and transverse myelitis
• Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study
• Received influenza vaccination or has had documented influenza disease in the last 6 months prior to informed consent.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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2,414 participants in 2 patient groups

QIVc

Experimental group

Description:

Cell-derived Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains

Treatment:

Biological: QIVc

Comparator QIV

Active Comparator group

Description:

Comparator Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains

Treatment:

Biological: Comparator QIV