Study on a High-Dose Quadrivalent Influenza Vaccine Compared With Standard-Dose Quadrivalent Influenza Vaccine in Children 6 Months Through 35 Months of Age
NCT ID: NCT04544267
Last Updated: 2025-12-24
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
100 participants
INTERVENTIONAL
2020-09-15
2021-06-02
Brief Summary
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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
Detailed Description
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Participants received either 1 or 2 doses of the study vaccine depending on whether they were previously influenza vaccinated or previously influenza unvaccinated, respectively.
Study duration per participant was approximately 6 to 7 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
A re-vaccination cohort was composed of a subset of approximately 120 participants from Season 1 (2021-2022 Northern Hemisphere) were re-enrolled and re-randomized in Season 3. The re-vaccination cohort was included, re-randomized to receive either QIV-HD or QIV-SD, provided blood samples in Season 1 and Season 3, and were not followed for ILI surveillance during their participation in Season 3.
PREVENTION
QUADRUPLE
* The unblinded qualified study staff member, independent of the safety evaluation and other study evaluations, administered the vaccine
* The Investigators (or delegates) in charge of safety assessment, the study staff who collect the safety data, and the laboratory personnel who analyze the blood samples did not know which product was administered
* The participant / parent / guardian did not know which product was administered. To maintain the blinding of the participant / parent / guardian, the vaccine syringe label was covered with appropriate materials prior to administration.
Study Groups
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QIV-HD
One injection of QIV-HD on Day 0. For participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered on Day 28.
Quadrivalent influenza vaccine, high-dose
Pharmaceutical form: suspension for injection in a pre-filled syringe; route of administration: intramuscular
QIV-SD
One injection of QIV-SD on Day 0. For participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered on Day 28.
Quadrivalent influenza vaccine, standard dose
Pharmaceutical form: suspension for injection in a pre-filled syringe; route of administration: intramuscular
Interventions
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Quadrivalent influenza vaccine, high-dose
Pharmaceutical form: suspension for injection in a pre-filled syringe; route of administration: intramuscular
Quadrivalent influenza vaccine, standard dose
Pharmaceutical form: suspension for injection in a pre-filled syringe; route of administration: intramuscular
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
6 Months
35 Months
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi Pasteur, a Sanofi Company
Locations
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California Research Foundation Site Number : 8400008
San Diego, California, United States
Acevedo Clinical Research Associates Site Number : 8400007
Miami, Florida, United States
Emory Childrens Center- Site Number : 8400001
Atlanta, Georgia, United States
Heartland El Dorado- Site Number : 8400032
El Dorado, Kansas, United States
Kentucky Pediatrics / Adult Research- Site Number : 8400005
Bardstown, Kentucky, United States
Velocity Clinical Research- New Orleans Site Number : 8400009
New Orleans, Louisiana, United States
Ohio Pediatric Research- Site Number : 8400027
Dayton, Ohio, United States
Rainbow Pediatrics- Site Number : 8400033
Barnwell, South Carolina, United States
Cenexel JBR- Site Number : 8400006
Salt Lake City, Utah, United States
Foothill Family Clinic South- Site Number : 8400045
Salt Lake City, Utah, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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QHD00014 Plain Language Results Summary
Other Identifiers
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U1111-1243-5993
Identifier Type: REGISTRY
Identifier Source: secondary_id
QHD00014
Identifier Type: OTHER
Identifier Source: secondary_id
2019-004721-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
QHD00014
Identifier Type: -
Identifier Source: org_study_id