Safety and Immunogenicity of Different Dosages of High-Dose Quadrivalent Influenza Vaccine in Children 6 Months to 17 Years of Age
NCT ID: NCT03698279
Last Updated: 2022-04-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
665 participants
INTERVENTIONAL
2018-10-09
2019-10-16
Brief Summary
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* To describe the safety of each dosage of high-dose quadrivalent influenza vaccine (QIV-HD) used in the study during the 28 days following each vaccination, and serious adverse events (including adverse events of special interest throughout the study).
* To describe the antibody response induced by each dosage of QIV-HD used in the study compared with unadjuvanted standard-dose quadrivalent influenza vaccine (QIV-SD) by hemagglutination inhibition (HAI) measurement method.
* To describe the antibody response induced by each dosage of QIV-HD used in the study compared with unadjuvanted QIV-SD by virus seroneutralization (SN) measurement method.
* To describe the antibody response induced by the highest acceptable dosage of QIV-HD compared with adjuvanted trivalent influenza vaccine (TIV) by HAI and virus SN measurement methods.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
PREVENTION
TRIPLE
Study Groups
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Group 1: QIV-HD 30 μg (US: 6 months to 17 years)
Participants from United States (US) (aged 6 months to 17 years) received single injection of 30 microgram (μg) QIV-HD, intramuscularly (IM) at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
High-Dose Quadrivalent Influenza Vaccine (QIV-HD) 30 μg (split-virion, inactivated)
Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM
Group 2: QIV-HD 45 μg (US: 6 months to 17 years)
Participants from US (aged 6 months to 17 years) received single injection of 45 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
High-Dose Quadrivalent Influenza Vaccine (QIV-HD) 45 μg, (split-virion, inactivated)
Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM
Group 3: QIV-HD, 60 μg (US: 6 months to 17 years)
Participants from US (aged 6 months to 17 years) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
High-Dose Quadrivalent Influenza Vaccine (QIV-HD) 60 µg (split-virion, inactivated)
Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM
Group 4: Pooled QIV-SD, 15 μg (US: 6 months to 17 years)
Pooled arm consisted of participants who were from US aged 6 months to 17 years, randomized to Groups 1, 2 and 3 and received single injection of 15 μg QIV-SD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
Fluarix Quadrivalent Influenza vaccine (Unadjuvanted QIV-SD) (Inactivated)
Pharmaceutical form: Solution for injection Route of administration: IM
Group 5: QIV-HD, 60 μg (Canada: 6 to <24 months)
Participants from Canada (aged 6 to less than \[\<\] 24 months) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
High-Dose Quadrivalent Influenza Vaccine (QIV-HD) 60 µg (split-virion, inactivated)
Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM
Group 6: Adjuvanted TIV (Canada: 6 to <24 months)
Participants from Canada (aged 6 to \<24 months) received single injection of 7.5 μg adjuvanted TIV, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
FLUAD Pediatric (adjuvanted TIV) (Surface Antigen, Inactivated)
Pharmaceutical form: Solution for injection Route of administration: IM
Interventions
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High-Dose Quadrivalent Influenza Vaccine (QIV-HD) 30 μg (split-virion, inactivated)
Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM
High-Dose Quadrivalent Influenza Vaccine (QIV-HD) 45 μg, (split-virion, inactivated)
Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM
High-Dose Quadrivalent Influenza Vaccine (QIV-HD) 60 µg (split-virion, inactivated)
Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM
Fluarix Quadrivalent Influenza vaccine (Unadjuvanted QIV-SD) (Inactivated)
Pharmaceutical form: Solution for injection Route of administration: IM
FLUAD Pediatric (adjuvanted TIV) (Surface Antigen, Inactivated)
Pharmaceutical form: Solution for injection Route of administration: IM
Eligibility Criteria
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Inclusion Criteria
* Assent form was signed and dated by the participant (7 to 17 years of age) and 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 were able to attend all scheduled visits and complied with all study procedures.
* For participants aged \<24 months: Born at full term of pregnancy (greater than or equal to \[\>=\] 37 weeks) and/or with a birth weight \>=2.5 kilogram.
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.
* Receipt of any vaccine in the 30 days preceding the first study vaccination, or planned receipt of any vaccine before Visit 3 for participants receiving 1 dose of influenza vaccine or Visit 5 for participants receiving 2 doses of influenza vaccine.
* For previously influenza vaccinated participants: Previous vaccination against influenza in the preceding 6 months with either the study vaccine or another vaccine.
* For previously influenza unvaccinated participants: Any influenza vaccination (from birth to the day of inclusion) with either the study vaccine or another influenza vaccine.
* For previously influenza unvaccinated participants: Any previous laboratory confirmed influenza infection (from birth to the day of inclusion)
* Receipt of immune globulins, blood or blood-derived products in the past 3 months.
* Known or suspected congenital or acquired immunodeficiency; 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.
* Thrombocytopenia or bleeding disorder, contraindicating IM vaccination based on Investigator's judgement.
* Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
* Current alcohol abuse or drug addiction.
* 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°Celsius \[\>=100.4°Fahrenheit\]). A prospective participant should not be included in the study until the condition had resolved or the febrile event had subsided.
* Identified as an immediate family member (i.e., spouse, natural or adopted child, grandchild, nephew, or niece) of the Investigator or employee with direct involvement in the proposed study.
* Personal history of Guillain-Barré 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.
* Known seropositivity for hepatitis B or hepatitis C.
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
6 Months
17 Years
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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Investigational Site Number 8400004
San Diego, California, United States
Investigational Site Number 8400001
Miami, Florida, United States
Investigational Site Number 8400002
Atlanta, Georgia, United States
Investigational Site Number 8400013
El Dorado, Kansas, United States
Investigational Site Number 8400015
Newton, Kansas, United States
Investigational Site Number 8400009
Wichita, Kansas, United States
Investigational Site Number 8400007
Metairie, Louisiana, United States
Investigational Site Number 8400010
Las Vegas, Nevada, United States
Investigational Site Number 8400011
Warwick, Rhode Island, United States
Investigational Site Number 8400003
Salt Lake City, Utah, United States
Investigational Site Number 8400012
Salt Lake City, Utah, United States
Investigational Site Number 8400005
Salt Lake City, Utah, United States
Investigational Site Number 8400014
West Jordan, Utah, United States
Investigational Site Number 1241003
Montreal, , Canada
Investigational Site Number 1241002
Pierrefonds, , Canada
Investigational Site Number 1241001
Québec, , Canada
Countries
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References
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Chang LJ, Anderson EJ, Jeanfreau R, He Y, Hicks B, Shrestha A, Pandey A, Landolfi V, DeBruijn I; QHD04 Study Group. Safety and immunogenicity of high doses of quadrivalent influenza vaccine in children 6 months through <18 years of age: A randomized controlled phase II dose-finding trial. Vaccine. 2021 Mar 12;39(11):1572-1582. doi: 10.1016/j.vaccine.2021.02.014. Epub 2021 Feb 18.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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U1111-1189-3713
Identifier Type: OTHER
Identifier Source: secondary_id
2018-005026-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
QHD04
Identifier Type: -
Identifier Source: org_study_id
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