Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects
Condition: Influenza; Human; Virus Diseases
MeSH terms: Influenza, Human; Virus Diseases
Intervention: QIVc; Comparator QIV
Intervention description: Previously vaccinated subjects received a 0.5 mL intramuscular dose of QIVc on Day 1; not previously vaccinated subjects received a 0.5 mL intramuscular dose of QIVc on Day 1 and Day 29.; Previously vaccinated subjects received a dose of Comparator QIV on Day 1; not previously vaccinated subjects received a dose of Comparator QIV on Day 1 and Day 29. Subjects 6 months through 35 months of age received a 0.25 mL intramuscular dose of Comparator QIV; subjects 36 months through 47 months of age received a 0.5 mL intramuscular dose of Comparator QIV.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: The trial is designed as an observer-blind study. During the treatment period of the study designated unblinded nurse(s), physician(s), or other qualified health care professional will be responsible for administering the study vaccine to the subjects.
Enrollment: 2414.0
Sex: All
Minimum age: 6 Months
Maximum age: 47 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; RNA Virus; WHO Strains

Summary:

      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.
    

Eligibility criteria:

        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.