Efficacy Study With QIVc in Pediatric Subjects
About the study
Who can take part
INCLUSION CRITERIA
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.
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
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 may be discussed by contacting the site.
Study Locations
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How to Apply
Study’s details
Contition
Influenza, Human
Age (in years)
6 - 47
Phase
Phase 3
Participants needed
3830
Est. Completion Date
Mar 31, 2024
Treatment type
Interventional
Sponsor
Seqirus
ClinicalTrials.gov identifier
NCT03932682
Study number
V130_14
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