Study With Quadrivalent Recombinant Influenza Vaccine (RIV4) in Participants 9 Through 49 Years of Age.

NCT05513053
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Phase
Phase 3
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Recruitment status
Completed
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Participants
1,308
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Lead sponsor
Sanofi Pasteur, a Sanofi Company
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Start date
2022-10-27
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Number of sites
35
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Summary
The purpose of this study was to demonstrate the non-inferiority (NI) of the HAI immune response of RIV4 in participants aged 9 to 17 years vs participants aged 18 to 49 years and to describe the immunogenicity and safety profile of RIV4 in all participants.
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Short title
Study With Quadrivalent Recombinant Influenza Vaccine (RIV4) in Participants 9 Through 49 Years of Age.
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Official title
Immunogenicity and Safety of Quadrivalent Recombinant Influenza Vaccine (RIV4) in Children and Adolescents Aged 9 to 17 Years and Adults Aged 18 to 49 Years.
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Control arm
Open label
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Registry reports results
Yes
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 3
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Study type
Interventional
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Completion date
2023-10-27
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First posted
2022-08-23
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Registry last updated
2025-09-09
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Primary completion date
2023-10-27
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Start date
2022-10-27
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Actual participants
1,308
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Participants
1,308
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Participant count basis
Actual
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Protocol amendments
2
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Number of sites
35
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Sanofi Pasteur, a Sanofi Company
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05513053
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ClinicalTrials.gov ID
NCT05513053
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Registry record
Open registry record
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Allocation
Not randomised
Model
Parallel groups
Purpose
Prevention
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Geometric Mean Titers (GMTs) Against Influenza Vaccine Antibodies at Day 29

    Timeframe: Day 29

    GMTs of anti-influenza antibodies were measured using individual hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages.

  2. Percentage of Participants With Seroconversion for Influenza Vaccine Antibodies at Day 29

    Timeframe: Day 29

    Anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Seroconversion was defined as either a pre-vaccination titer less than (\<) 1:10 (1/dilution) at Day 1 and a post-vaccination titer greater than or equal to (\>=) 1: 40 (1/dilution) at Day 29 or a pre-vaccination titer \>= 1:10 at Day 1 and a \>= 4-fold increase in post-vaccination titer.

  1. GMTs Against Influenza Vaccine Antibodies at Day 1

    Timeframe: Pre-vaccination on Day 1

    GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages.

  2. Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29

    Timeframe: On Days 1 and 29

    Antibody titers were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Percentage of participants with antibody titers \>=10 and \>=40 against influenza vaccine antibodies at Day 1 and Day 29 were reported in this outcome measure.

  3. Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies

    Timeframe: On Days 1 and 29

    GMTR was the ratio of the individual titers post-vaccination over pre-vaccination. The GMTs were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages.

  4. Number of Participants With Immediate Unsolicited Adverse Events (AEs)

    Timeframe: Within 30 minutes post-vaccination on Day 1

    An AE was any untoward medical occurrence in a clinical investigation 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, that is, prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs.

  5. Number of Participants With Solicited Injection Site Reactions and Systemic Reactions

    Timeframe: From Day 1 up to 7 days post-vaccination (up to Day 8)

    A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted in the protocol and CRF and considered as related to the study intervention administered. An injection site reaction was an AR at and around the injection site and were commonly inflammatory reactions. Solicited systemic reactions were systemic AEs and those occurring during the specified collection period were always considered related to the intervention even if there was evidence of alternative etiology.

  6. Number of Participants With Unsolicited AEs

    Timeframe: From Day 1 up to 28 days post-vaccination (up to Day 29)

    An AE was any untoward medical occurrence in a clinical investigation 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, that is, prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination.

  7. Number of Participants With Medically Attended Adverse Events (MAAEs)

    Timeframe: From Day 1 up to 28 days post-vaccination (up to Day 29)

    An MAAE was a new onset or a worsening of a condition that prompted the participant or participant's parent/guardian to seek unplanned medical advice at a physician's office or emergency department.

  8. Number of Participants With Serious Adverse Events (SAEs) And Adverse Events of Special Interest (AESI)

    Timeframe: From Day 1 up to 6 months post-vaccination, 181 days

    An SAE was any untoward medical occurrence 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 an important medical event. An AESI was defined as one of scientific and medical concern specific to the Sponsor's study intervention, events for which ongoing monitoring and rapid communication by the investigator to the sponsor was done.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Children, Adults
Minimum age
9 Years
Maximum age
49 Years
Healthy volunteers
Yes

  • Aged 9 to 49 years on the day of inclusion
  • A female participant was eligible to participate if she was not pregnant or breastfeeding and one of the following conditions applies: 1) was of non-childbearing potential. To be considered of non-childbearing potential, a female should have been pre-menarche, post-menopausal for at least 1 year, or surgically sterile OR 2) was of childbearing potential and agreed to use an effective contraceptive method or abstinence from at least 4 weeks prior to the first study intervention administration until at least 4 weeks after the last study intervention administration
  • Assent form or informed consent form had been signed and dated by the participant (based on local regulations), and if applicable informed consent form had been signed and dated by the parent(s) or another legally acceptable representative

  • 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 was not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Sources for eligibility
clinicaltrials.gov

  • Alabama Clinical Therapeutics North Tower Site Number : 8400024Birmingham, United States
  • Birmingham Pediatric Associates Site Number : 8400023Birmingham, United States
  • The Children's Clinic Of Jonesboro PA Site Number : 8400025Jonesboro, United States
  • California Research Foundation Site Number : 8400003San Diego, United States
  • Meridian Clinical Research- Sioux City Site Number : 8400007Sioux City, United States
  • AMR - Newton Site Number : 8400021Newton, United States
  • Kentucky Pediatics / Adult Research Site Number : 8400010Bardstown, United States
  • Velocity Clinical Research Site Number : 8400012New Orleans, United States
  • Velocity Clinical Research Lincoln Site Number : 8400013Lincoln, United States
  • Meridian Clinical Research Norfolk Site Number : 8400011Norfolk, United States
  • Velocity Clinical Research, Omaha Site Number : 8400009Omaha, United States
  • Meridian Clinical Research Site Number : 8400006Binghamton, United States
  • Velocity Clinical Research Vestal Site Number : 8400016Vestal, United States
  • Ohio Pediatric Research Site Number : 8400020Dayton, United States
  • Rainbow Pediatrics Site Number : 8400014Barnwell, United States
  • Coastal Pediatric Research Charleston Site Number : 8400005Charleston, United States
  • Coastal Carolina Research Center - N Charleston Site Number : 8400022North Charleston, United States
  • Benchmark Research - Austin Site Number : 8400004Austin, United States
  • JBR Clinical Research Site Number : 8400001Salt Lake City, United States
  • J. Lewis Research Site Number : 8400017Salt Lake City, United States
  • Velocity Clinical Research Portsmouth Site Number : 8400015Portsmouth, United States
  • Investigational Site Number : 2030001Jindřichův Hradec, Czechia
  • Investigational Site Number : 6160010Bydgoszcz, Poland
  • Investigational Site Number : 6160007Bydgoszcz, Poland
  • Investigational Site Number : 6160004PuÅ'awy, Poland

And 10 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • U1111-1260-4678
  • 2022-000577-11
  • VAP00027
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (2)