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Influenza, Human

Efficacy Study With QIVc in Pediatric Subjects
NCT03932682 | Phase 3 | Interventional

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.

Trial Information
19 Sites
3830 Participants
6 Months to 47 Months

If interested, contact for more information

UERM Memorial Medical Center
Quezon City,Philippines,547530
Health Index Multispecialty Clinic
Chong Hua Hospital
Cebu City,Philippines,10400
De La Salle Medical and Health Sciences Institute
De La Salle Medical and Health Sciences Institute
Philippine General Hospital
Philippine General Hospital
Philippine General Hospital
UERM Memorial Medical Center
Quezon City,Philippines
Philippine Children's Medical Center
Quezon City,Philippines
Madibeng Centre for Research
Brits,South Africa
Tread Research
Cape Town,South Africa
Allergy & Immunology Unit
Cape Town,South Africa
Synergy Biomed Research Institute
East London,South Africa
Perinatal HIV Research Unit, Tshepong Hospital
Klerksdorp,South Africa
Be Part Yoluntu Centre
Paarl,South Africa
Clinical Trial Systems
Pretoria,South Africa
Soweto Clinical Trials Centre
Soweto,South Africa
Limpopo Clinical Research Initiative
Thabazimbi,South Africa

Study Eligibility 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.
  • 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.

Additional Studies

Additional studies can be found at