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Study on a High-Dose Quadrivalent Influenza Vaccine Compared With Standard-Dose Quadrivalent Influenza Vaccine in Children 6 Months Through 35 Months of Age
Study on a High-Dose Quadrivalent Influenza Vaccine Compared With Standard-Dose Quadrivalent Influenza Vaccine in Children 6 Months Through 35 Months of Age

NCT04544267

TerminatedPhase 3

Sponsor: Sanofi Pasteur, a Sanofi Company

Conditions: Influenza

Interventions: Quadrivalent influenza vaccine, high-dose, Quadrivalent influenza vaccine, standard dose

Countries: United States

The primary objective of the study was to compare the clinical efficacy of high-dose quadrivalent influenza vaccine (QIV-HD) to standard-dose quadrivalent influenza vaccine (QIV-SD) in participants 6 months through 35 months of age for the prevention of laboratory-confirmed influenza illness caused by any influenza A or B type. The secondary objectives of the study were: * To compare QIV-HD to QIV-SD: * in participants 6 months through 35 months of age for the prevention of laboratory-confirmed influenza illness caused by any influenza A or B type using a more stringent threshold * in participants 6 months through 35 months of age for the prevention of laboratory-confirmed protocol-defined influenza-like illness caused by viral strains similar to those contained in the vaccine. * in participants 6 months through 23 months of age for the prevention of laboratory-confirmed influenza illness caused by any influenza A or B types. * To compare hemagglutination inhibition (HAI) immune response of QIV-HD to QIV-SD in participants 6 months through 35 months of age * To describe the HAI, seroneutralization (SN), and anti-neuraminidase (NA) immune response * To describe the immune response to revaccination in Season 3 (Northern Hemisphere) * To describe the safety profile of each vaccine

Eligibility overview

Sex: ALL

Age: 6 Months to 35 Months

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion criteria :

* Aged 6 to 35 months on the day of the first study visit
* Informed consent form was signed and dated by the parent(s) or guardian(s) and by an independent witness, if required by local regulations.
* Participant and parent / guardian who were able to attend all scheduled visits and to comply with all study procedures.
* Covered by health insurance if required by local regulations
* For Season 3 Re-vaccination Cohort: eligible participants must have been enrolled in the Season 1 (2021-2022 Northern Hemisphere season) immunogenicity subset and must have completed all study procedures (ie, blood draws and vaccinations) in Season 1.

Exclusion criteria:

* Participation at the time of study enrollment (or in the 4 weeks preceding the first study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.
* For all participants: Receipt of any vaccine in the 30 days preceding the first study vaccination. For participants in immunogenicity subset: Planned receipt of any vaccine before Visit 2 for participants receiving 1 dose of influenza vaccine or Visit 3 for participants receiving 2 doses of influenza vaccine.
* Previous vaccination against influenza in the preceding 6 months with either the study vaccine or another influenza vaccine
* Receipt of immune globulins, blood or blood-derived products in the past 3 months.
* Known or suspected congenital or acquired immunodeficiency (eg, HIV); or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
* Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances. Exception: participants with an egg allergy are allowed to enroll in the study.
* Thrombocytopenia, bleeding disorder, or receipt of anticoagulants that based on Investigator's judgment contraindicate intramuscular vaccination
* Chronic illness that, in the opinion of the investigator, was at a stage where it might interfere with study conduct or completion.
* Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0 C \[≥ 100.4 F\]). A prospective participant would not be included in the study until the condition was resolved or the febrile event was subsided.
* Identified as natural or adopted child of the Investigator or employee with direct involvement in the proposed study.
* Personal or family history of Guillain-Barre Syndrome.
* Any condition that in the opinion of the Investigator would pose a health risk to the participant if enrolled or could interfere with the evaluation of the vaccine.
* Personal history of clinically significant development delay (at the discretion of the Investigator), neurologic disorder, or seizure disorder.
* For Season 3 (2022-2023 Northern Hemisphere) main cohort: participants who were enrolled in a previous study season are excluded from Season 3, with the exception of the Re-vaccination Cohort.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Locations (10)
  • San Diego, California, United States
  • Miami, Florida, United States
  • Atlanta, Georgia, United States
  • El Dorado, Kansas, United States
  • Bardstown, Kentucky, United States
  • New Orleans, Louisiana, United States
  • Dayton, Ohio, United States
  • Barnwell, South Carolina, United States
  • Salt Lake City, Utah, United States
  • Salt Lake City, Utah, United States