Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Quadrivalent RIV with H3 strain 1 · 2 trials · 3 indications
Immediate adverse events are unsolicited systemic adverse events reported in the 30 minutes after vaccination
Solicited injection site reactions: injection site pain, erythema, swelling, induration and bruising; solicited systemic reactions: fever, headache, malaise, and myalgia
Unsolicited (spontaneously reported) adverse events not not fulfilling criteria for solicited reactions
Serious adverse events are collected throughout the study
Adverse events of special interest are collected throughout the study
Laboratory tests include complete blood count (CBC), platelet count, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, serum creatinine, serum lipase, and serum amylase)
Influenza antibody titers are measured by HAI and SN assays
Titers ratio is calculated for the following time points: Day 7/Day 0, Day 28/Day 0, and Day 90/Day 0
Seroconversion is defined as HAI antibody titer \< 10 \[1/dil\] at Day 0 and post-injection titer ≥ 40 \[1/dil\] at Day 28, or titer ≥ 10 \[1/dil\] at Day 0 and a ≥ 4-fold increase in titer \[1/dil\] at Day 28)
Influenza vaccine antibody titers are measured by HAI assay
Influenza vaccine antibody titers are measured by SN assay
Influenza vaccine antigens are measured by HAI assay
Titers ratio are calculated for Day 8/Day 0 and Day 28/Day 0, Day 56/Day 28 and Day 90/Day 28
Seroconversion is defined as HAI antibody titer \< 10 \[1/dil\] at Day 0 and post-injection titer ≥ 40 \[1/dil\] at Day 28, or titer ≥ 10 \[1/dil\] at Day 0 and a ≥ 4-fold increase in titer \[1/dil\] at Day 28
Influenza vaccine antigens are measured by HAI assay
| Arm | Type | Description |
|---|---|---|
| Group 1: Quadrivalent RIV with H3 strain 1, without adjuvant | EXPERIMENTAL | 1 injection of quadrivalent RIV containing H3 strain 1, without adjuvant, in participants ≥ 50 years old |
| Group 2: Quadrivalent RIV with H3 strain 1, with adjuvant | EXPERIMENTAL | 1 injection of quadrivalent RIV containing H3 strain 1, with adjuvant, in participants ≥ 50 years old |
| Group 3: Quadrivalent RIV with H3 strain 2, without adjuvant | EXPERIMENTAL | 1 injection of quadrivalent RIV containing H3 strain 2, without adjuvant, in participants ≥ 50 years old |
| Group 4: Quadrivalent RIV with H3 strain 2, with adjuvant | EXPERIMENTAL | 1 injection of quadrivalent RIV containing H3 strain 2, with adjuvant, in participants ≥ 50 years old |
| Group 5: Quadrivalent RIV Control, without adjuvant | ACTIVE_COMPARATOR | 1 injection of quadrivalent RIV containing 2018-19 Northern Hemisphere (NH) recommended H3 strain, without adjuvant, in participants ≥ 50 years old |
| Group 6: Quadrivalent RIV Control, with adjuvant | ACTIVE_COMPARATOR | 1 injection of quadrivalent RIV containing 2018-19 NH recommended H3 strain, with adjuvant, in participants ≥ 50 years old |
| Group 7: Quadrivalent RIV Control, without adjuvant | ACTIVE_COMPARATOR | 1 injection of quadrivalent RIV containing 2018-19 NH recommended H3 strain, without adjuvant, in participants 18-30 years old |
| Quadrivalent RIV with H3 strain 1 | EXPERIMENTAL | 1 injection of Quadrivalent RIV containing H3 strain 1 |
| Quadrivalent RIV with H3 strain 2 | EXPERIMENTAL | 1 injection of Quadrivalent RIV containing H3 strain 2 |
| Quadrivalent RIV with H3 strain 3 | EXPERIMENTAL | 1 injection of Quadrivalent RIV containing H3 strain 3 |
| Quadrivalent RIV with H3 strain 4 | EXPERIMENTAL | 1 injection of Quadrivalent RIV containing H3 strain 4 |
| Quadrivalent RIV Control | ACTIVE_COMPARATOR | 1 injection of Quadrivalent RIV containing 2018-19 NH recommended H3 strain |
| Name | Type | Description |
|---|---|---|
| Quadrivalent RIV with H3 strain 1 | BIOLOGICAL | Pharmaceutical form: Suspension for injection Route of administration: Intramuscular |
| Quadrivalent RIV with H3 strain 1 and adjuvant | BIOLOGICAL | Pharmaceutical form: Suspension for injection Route of administration: Intramuscular |
| Quadrivalent RIV with H3 strain 2 | BIOLOGICAL | Pharmaceutical form: Suspension for injection Route of administration: Intramuscular |
| Quadrivalent RIV with H3 strain 2 and adjuvant | BIOLOGICAL | Pharmaceutical form: Suspension for injection Route of administration: Intramuscular |
| Quadrivalent RIV with 2018-2019 NH H3 strain | BIOLOGICAL | Pharmaceutical form: Suspension for injection Route of administration: Intramuscular |
| Quadrivalent RIV with 2018-2019 NH H3 strain and adjuvant | BIOLOGICAL | Pharmaceutical form: Suspension for injection Route of administration: Intramuscular |
| Quadrivalent RIV with H3 strain 3 | BIOLOGICAL | Pharmaceutical form: Pre-filled single-dose vial Route of administration: Intramuscular |
| Quadrivalent RIV with H3 strain 4 | BIOLOGICAL | Pharmaceutical form: Pre-filled single-dose vial Route of administration: Intramuscular |
Inclusion criteria : * Older adults: Aged 50 years and older on the day of inclusion Young adults: Aged 18 to 30 years on the day of inclusion * Informed consent form has been signed and dated * Able to attend all scheduled visits and to comply with all trial procedures Exclusion criteria: * Part...
Quadrivalent RIV with H3 strain 1 is an investigational quadrivalent recombinant influenza vaccine being studied for the prevention of influenza and for influenza immunisation. It is designed to provide protection against four influenza strains, including a specific H3 hemagglutinin antigen, and is intended for use in healthy adults.
Quadrivalent RIV with H3 strain 1 is being developed by Sanofi, a biopharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is conducting clinical trials to evaluate the safety and immunogenicity of this vaccine candidate in adult populations.
Quadrivalent RIV with H3 strain 1 is in Phase 1 clinical development. It is an investigational vaccine that has not yet been approved by regulatory authorities. The Phase 1 trials have been completed, and the vaccine remains under evaluation for its safety and immune response in healthy adults.
Quadrivalent RIV with H3 strain 1 has been studied in two completed Phase 1 clinical trials: NCT04144179, which evaluated different H3 hemagglutinin antigens in 150 healthy adults aged 18 to 30 years, and NCT04451954, which assessed the vaccine with or without adjuvant in 210 healthy adults. Both trials were conducted in the United States.
Quadrivalent RIV with H3 strain 1 is classified as a recombinant influenza vaccine, not a monoclonal antibody. It is a quadrivalent vaccine designed to elicit an immune response against four influenza strains, including an H3 strain. The trials listed for this vaccine focus on its immunogenicity and safety in healthy adults.