Study With Quadrivalent Recombinant Influenza Vaccine (RIV4) Compared With Egg-Based Quadrivalent Influenza Vaccine (IIV4) in Participants Aged 3 to 8 Years
- Conditions
- Influenza Immunization
- Interventions
- Biological: Quadrivalent influenza vaccine (IIV4)Biological: Recombinant influenza vaccine (RIV4)
- Registration Number
- NCT05513391
- Lead Sponsor
- Sanofi Pasteur, a Sanofi Company
- Brief Summary
The purpose of this study was to demonstrate the non-inferior HAI immune response of quadrivalent recombinant influenza vaccine (RIV4) vs licensed Egg-Based Quadrivalent Influenza Vaccine (IIV4) for the 4 strains based on the egg-derived antigen in all participants aged 3 to 8 years and to describe the immunogenicity and safety profile of RIV4 compared to IIV4 in participants aged 3 to 8 years.
- Detailed Description
Participants were enrolled on the day of their first vaccination and received 1 or 2 doses 28 days apart of either RIV4 or IIV4; depending on if they were previously vaccinated against influenza or previously unvaccinated against influenza, respectively; and were followed for 6 months after the last vaccination.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 366
- Aged 3 to 8 years on the day of inclusion
- Assent form has been signed and dated by the participant (according to local regulations), and informed consent form has been signed and dated by the parent(s) or another legally acceptable representative and by an independent witness, if required by local regulations
- 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 trial or to a vaccine containing any of the same substances
- Thrombocytopenia
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination based on the Investigator's judgment
- Personal or family history of Guillain-Barre Syndrome (GBS)
- Personal history of clinically significant development delay (at the discretion of the Investigator), neurologic disorder, or seizure disorder NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IIV4 cohort Quadrivalent influenza vaccine (IIV4) IIV4, single injection at Day 1 RIV4 cohort Recombinant influenza vaccine (RIV4) RIV4 single injection at Day 1
- Primary Outcome Measures
Name Time Method Percentage of Participants With Seroconversion (SC) Against Antigens 28 Days After the Last Vaccination Day 29 [participants previously vaccinated] or Day 57 [participants previously unvaccinated] Anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1 strain, A/H3N2 strain, B/Victoria lineage strain, and B/Yamagata lineage strain. SC was defined as either a pre-vaccination HAI titer less than (\<) 10 (1/dilution) and a post-vaccination titer greater than or equal to (≥) 40 (1/dilution) or a pre-vaccination titer ≥ 10 (1/dilution) and a ≥ 4-fold increase in post-vaccination titer.
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies 28 Days After the Last Vaccination Day 29 [participants previously vaccinated] or Day 57 [participants previously unvaccinated] GMTs of influenza vaccine antibodies were measured using individual hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1 strain, A/H3N2 strain, B/Victoria lineage strain, and B/Yamagata lineage strain.
- Secondary Outcome Measures
Name Time Method Number of Participants With Unsolicited AEs Up to Day 29 (all participants); Up to Day 57 (participants previously unvaccinated) An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, i.e., pre-listed in the CRF in terms of diagnosis and onset window post-vaccination.
Number of Participants With Medically Attended Adverse Events (MAAEs) Up to Day 29 (all participants); Up to Day 57 (participants previously unvaccinated) An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An MAAE was a new onset or a worsening of a condition that prompted the participant or participant's parent/legally acceptable representative to seek unplanned medical advice at a physician's office or emergency department.
Number of Participants With Serious Adverse Events (SAEs) And Adverse Events of Special Interest (AESI) From the first vaccination up to 6 months after the last vaccination, 209 days An SAE was defined as any adverse event that, at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was other medically important event. An AESI was defined as one of scientific and medical concern specific to the Sponsor's study intervention or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor was appropriate.
GMTs of Influenza Vaccine Antibodies at Day 1 Pre-vaccination on Day 1 GMTs of influenza vaccine antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1 strain, A/H3N2 strain, B/Victoria lineage strain, and B/Yamagata lineage strain.
Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies Day 1 (all participants) and Day 29 (participants previously vaccinated) or Day 57 (participants previously unvaccinated) GMTR was the ratio of the individual titers post-vaccination over pre-vaccination. The GMTs of influenza vaccine antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1 strain, A/H3N2 strain, B/Victoria lineage strain, and B/Yamagata lineage strain.
Number of Participants With Immediate Unsolicited Adverse Events (AEs) Within 30 minutes post-vaccination on Day 1 (all participants) and Day 29 (participants previously unvaccinated) An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, i.e., pre-listed in the case report form (CRF) in terms of diagnosis and onset window post-vaccination. Immediate events were recorded to capture medically relevant unsolicited systemic AEs which occurred within the first 30 minutes after vaccination.
Number of Participants With Solicited Injection Site Reactions and Systemic Reactions Day 1 to Day 8 (all participants); Day 29 to Day 36 (participants previously unvaccinated) Solicited injection site reactions were reactions at and around the injection/administration site of the investigational medicinal product (IMP) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF and considered as being related to the IMP administered at that site. Solicited systemic reactions were systemic AEs observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF, and those occurring during the specified collection period were always considered related to the IMP even if there was evidence of alternative etiology.
Percentage of Participants With Detectable HAI Titer ≥ 10 and ≥ 40 for Influenza Vaccine Antibodies at Day 1 and 28 Days After the Last Vaccination Day 1 (all participants) and Day 29 (participants previously vaccinated) or Day 57 (participants previously unvaccinated) Antibody titers were measured using HAI assay for 4 influenza virus strains: A/H1N1 strain, A/H3N2 strain, B/Victoria lineage strain, and B/Yamagata lineage strain.
Trial Locations
- Locations (31)
Velocity Clinical Research Omaha Site Number : 8400009
🇺🇸Omaha, Nebraska, United States
Velocity Clinical Research Lincoln Site Number : 8400013
🇺🇸Lincoln, Nebraska, United States
Rainbow Pediatrics Site Number : 8400014
🇺🇸Barnwell, South Carolina, United States
Coastal Pediatric Research Charleston Site Number : 8400005
🇺🇸Charleston, South Carolina, United States
The Children's Clinic Of Jonesboro PA Site Number : 8400025
🇺🇸Jonesboro, Arkansas, United States
Kentucky Pediatrics / Adult Research Site Number : 8400010
🇺🇸Bardstown, Kentucky, United States
Coastal Carolina Research Center Site Number : 8400022
🇺🇸North Charleston, South Carolina, United States
Investigational Site Number : 6160001
🇵🇱Warszawa, Poland
Investigational Site Number : 7240004
🇪🇸Madrid, Spain
Investigational Site Number : 7240005
🇪🇸Malaga, Spain
Investigational Site Number : 7240014
🇪🇸Madrid, Madrid, Comunidad De, Spain
Investigational Site Number : 6160006
🇵🇱Tarnow, Poland
Investigational Site Number : 6160012
🇵🇱Wroclaw, Poland
Investigational Site Number : 7240018
🇪🇸Madrid, Spain
Investigational Site Number : 7240001
🇪🇸Móstoles, Spain
California Research Foundation Site Number : 8400003
🇺🇸San Diego, California, United States
J. Lewis Research Site Number : 8400017
🇺🇸Salt Lake City, Utah, United States
AMR - Newton Site Number : 8400021
🇺🇸Newton, Kansas, United States
Birmingham Pediatric Associates Site Number : 8400023
🇺🇸Birmingham, Alabama, United States
Meridian Clinical Research- Sioux City Site Number : 8400007
🇺🇸Sioux City, Iowa, United States
Velocity Clinical Research- New Orleans Site Number : 8400012
🇺🇸New Orleans, Louisiana, United States
Meridian Clinical Research Site Number : 8400006
🇺🇸Binghamton, New York, United States
Ohio Pediatric Research Site Number : 8400020
🇺🇸Dayton, Ohio, United States
Velocity Clinical Research Vestal Site Number : 8400016
🇺🇸Vestal, New York, United States
JBR Clinical Research Site Number : 8400001
🇺🇸Salt Lake City, Utah, United States
Investigational Site Number : 6160010
🇵🇱Bydgoszcz, Kujawsko-pomorskie, Poland
Alliance for Multispecialty Research Syracuse Site Number : 8400027
🇺🇸Syracuse, Utah, United States
Investigational Site Number : 6160007
🇵🇱Bydgoszcz, Kujawsko-pomorskie, Poland
Investigational Site Number : 6160005
🇵🇱Siemianowice Śląskie, Slaskie, Poland
Investigational Site Number : 6160003
🇵🇱Bydgoszcz, Poland
Investigational Site Number : 7240007
🇪🇸Sevilla, Spain