Efficacy Study With QIVc in Pediatric Subjects

Seqirus

Status and phase: Completed; Phase 3

Conditions: Influenza, Human

Treatments: Biological: Comparator; Biological: QIVc

Study type: Interventional

Funder types: Industry

Identifiers

NCT03932682

2018-001857-29 (EudraCT Number)

V130_14

Details and patient eligibility

About

This phase 3 clinical study is a randomized, observer-blind, multicenter study of QIVc versus a non-influenza vaccine in subjects 6 months though 47 months of age. The purpose of this study is to evaluate efficacy of QIVc in the prevention of laboratory confirmed influenza A or B disease in children 6 through 47 months of age, compared to a non-influenza vaccine.

Enrollment: 5,723 patients

Sex: All

Ages: 6 to 47 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

In order to participate in this study, all subjects must meet all of the inclusion criteria described.

• 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.
• Individuals in generally good health as per the Investigator's medical judgement.

If applicable, prior to receipt of second study vaccination, subjects must be evaluated to confirm that they are eligible for subsequent vaccination. If subjects do not meet the criteria of the original inclusion criteria listed above, they should not receive additional vaccinations.

Exclusion criteria

• Acute (severe) febrile illness. Enrollment could be considered if the fever is absent for 72 hours.
• 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.
• Clinical conditions representing a contraindication to intramuscular vaccination and blood draws. These may include known bleeding disorders, or treatment with anticoagulants in the 3 weeks preceding vaccination.
• A known history of Guillain-Barré Syndrome or other demyelinating diseases such as encephalomyelitis and transverse myelitis.
• Abnormal function of the immune system resulting from a clinical condition
• Received influenza vaccination or has had documented influenza disease in the last 6 months prior to informed consent.
• Prior vaccination to prevent Neisseria meningitides serogroup C disease or prior infection caused by this organism.

Additional eligibility criteria are provided in the study protocol.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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5,723 participants in 2 patient groups

QIVc

Experimental group

Description:

Cell-derived Quadrivalent Influenza Vaccine

Treatment:

Biological: QIVc

Comparator

Active Comparator group

Description:

Non-influenza Comparator

Treatment:

Biological: Comparator