Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04451954 | Study of Recombinant Influenza Vaccine Containing Different H3 Antigens Without or With Adjuvant in Healthy Adult Subjects | PHASE1 | COMPLETED | 210 | — | — | Jul 2, 2020 | Sep 20, 2021 | Sep 17, 2025 | 5 | United States |
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
| 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 |
| 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 |
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...