Phase 3
N=1,308
Study With Quadrivalent Recombinant Influenza Vaccine (RIV4) in Participants 9 Through 49 Years of Age.
Influenza Immunization
Bottom Line
View on ClinicalTrials.gov: NCT05513053 ↗Enrolled (actual)
1,308
Serious AEs
0.8%
Results posted
May 2024
Primary outcome: Primary: Geometric Mean Titers (GMTs) Against Influenza Vaccine Antibodies at Day 29 — 1946; 982; 1975; 604 titer
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Quadrivalent Recombinant influenza vaccine (RIV4) season/2022-2023/NH (Biological)
- Age
- Pediatric, Adult · 9+ yrs
- Sex
- All
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Titers (GMTs) Against Influenza Vaccine Antibodies at Day 29 |
1946; 982; 1975; 604; 405; 258 | — |
| PRIMARY Percentage of Participants With Seroconversion for Influenza Vaccine Antibodies at Day 29 |
78.3; 76.4; 86.5; 87.1; 76.8; 73.6 | — |
| SECONDARY GMTs Against Influenza Vaccine Antibodies at Day 1 |
154; 74.9; 111; 29.0; 48.1; 37.3 | — |
| SECONDARY Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29 |
97.0; 89.8; 100; 99.3; 87.2; 71.8 | — |
| SECONDARY Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies |
12.7; 13.1; 17.9; 20.8; 8.41; 6.91 | — |
| SECONDARY Number of Participants With Immediate Unsolicited Adverse Events (AEs) |
1; 0 | — |
| SECONDARY Number of Participants With Solicited Injection Site Reactions and Systemic Reactions |
220; 259; 182; 230 | — |
| SECONDARY Number of Participants With Unsolicited AEs |
93; 119 | — |
| SECONDARY Number of Participants With Medically Attended Adverse Events (MAAEs) |
27; 35 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs) And Adverse Events of Special Interest (AESI) |
3; 7; 0; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT05513053). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.