For Healthcare Professionals

Efficacy Study With QIVc in Pediatric Subjects

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About the study

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 Reverse transcription polymerase chain reaction (RT-PCR) confirmed influenza A or B disease in children 6 through 47 months of age, compared to a non-influenza vaccine.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

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

  1. Individuals of 6 through 47 months of age on the day of informed consent.
  2. 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.
  3. Individuals who can comply with study procedures including follow-up.
  4. Individuals in generally good health as per the Investigator's medical judgement. 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

  1. Acute (severe) febrile illness. Enrollment could be considered if the fever is absent for 72 hours.
  2. 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.
  3. 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.
  4. A known history of Guillain-Barré Syndrome or other demyelinating diseases such as encephalomyelitis and transverse myelitis.
  5. Abnormal function of the immune system resulting from a clinical condition
  6. Received influenza vaccination or has had documented influenza disease in the last 6 months prior to informed consent.
  7. Prior vaccination to prevent Neisseria meningitides serogroup C disease or prior infection caused by this organism. Additional eligibility criteria may be discussed by contacting the site.
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall (855) 358-8966Email iconEmail Study Center

Study’s details


Contition

Influenza, Human,Prophylaxis of Influenza Virus Infection

Age

6+

Phase

Phase 3

Participants needed

3830

Est. Completion Date

Mar 2024

Treatment type

Interventional


Sponsor

Seqirus

ClinicalTrials.gov identifier

NCT03932682

Study number

V130_14

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