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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04210349 | Study of Shenzhen Quadrivalent Inactivated Influenza Vaccine Versus the Shenzhen Trivalent Inactivated Influenza Vaccine in Chinese Subjects From 6 Months of Age | PHASE3 | COMPLETED | 7,106 | — | — | Jan 9, 2020 | Dec 1, 2020 | Sep 16, 2025 | 7 | China |
| NCT03765437 | Safety of a Quadrivalent Influenza Vaccine (VaxigripTetra™) in Subjects Aged 6 Months and Older in Vietnam | PHASE3 | COMPLETED | 230 | — | — | Jan 15, 2019 | Mar 17, 2019 | Apr 25, 2022 | 1 | Vietnam |
| NCT01240746 | Study of Quadrivalent Influenza Vaccine Among Children | PHASE3 | COMPLETED | 4,363 | — | — | Nov 1, 2010 | Feb 1, 2012 | Jul 14, 2015 | 67 | United States |
| NCT05048589 | Feasibility of Randomizing Danish Citizens Aged 65-79 Years to High-Dose Quadrivalent Influenza Vaccine vs. Standard-Dose Quadrivalent Influenza Vaccine in a Pragmatic Registry-Based Setting | PHASE2 | COMPLETED | 12,551 | — | — | Oct 1, 2021 | May 31, 2022 | Aug 23, 2022 | 2 | Denmark |
Geometric mean titers will be assessed by a hemagglutination (HAI) method
Influenza antibodies will be assessed using the HAI method.
Geometric mean titers will be assessed by a HAI method
Influenza antibodies will be assessed using the HAI method.
Immediate adverse events includes unsolicited systemic adverse events occuring within 30 minutes after vaccination
Injection site reactions: injection site tenderness/pain, erythema, swelling, induration, and ecchymosis. Systemic reactions: fever, vomiting, crying abnormal, drowsiness, appetite lost, and irritability for toddlers aged \<= 23 months and fever, headache, malaise, myalgia and shivering for participants aged \> 2 years.
Adverse events other than solicited reactions
Serious adverse events (including adverse event of special interest) are assessed throughout the study.
Injection site reactions: tenderness/pain, erythema, swelling, induration, and haemorrhage. Systemic reactions: participants ≤ 23 months: fever, vomiting, crying abnormal, drowsiness, appetite lost, and irritability; participants 2 years and older: fever, headache, malaise, myalgia, and shivering.
Immunogenicity outcomes were assessed in serum samples by hemagglutination inhibition (HAI) assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10.
Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10.
Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10.
Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10.
Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10.
First hospitalization with a primary (A) diagnosis code for influenza or pneumonia of at least 1 night duration
First hospitalization with a primary (A) diagnosis code for respiratory disease of at least 1 night duration
First hospitalization with a primary (A) diagnosis code for cardio-respiratory disease of at least 1 night duration
First hospitalization with a primary (A) diagnosis code for cardiovascular disease of at least 1 night duration
First hospitalization with any diagnosis code of at least 1 night duration
Death from any cause
First hospitalization with a primary (A) diagnosis code for COVID-19 of at least 1 night duration
| Arm | Type | Description |
|---|---|---|
| Group A: 6 to 35 months, previously unvaccinated, step 1 | EXPERIMENTAL | Participants will receive two injections of SP Shz QIV 0.5 mL at Day 0 and Day 28 |
| Group 1: 6 to 35 months, step 2 | EXPERIMENTAL | Participants will receive one injection of SP Shz QIV 0.25 mL or SP Shz QIV 0.5 mL at Day 0 or SP Shz TIV1 0.25 mL or SP Shz TIV2 0.25 mL at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
| Group 2: 3 to 8 years, step 2 | EXPERIMENTAL | Participants will receive one injection of SP Shz QIV 0.5 mL or SP Shz QIV 0.5 mL or SP Shz TIV1 0.5 mL or SP Shz TIV2 0.5 mL at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
| Group 3: 9 to 17 years, step 2 | EXPERIMENTAL | Participants will receive one injection of SP Shz QIV 0.5 mL or SP Shz TIV1 0.5 mL or SP Shz TIV2 0.5 mL at Day 0. |
| Group 4: 18 to 60 years, step 2 | EXPERIMENTAL | Participants will receive one injection of SP Shz QIV 0.5 mL or SP Shz TIV1 0.5 mL or SP Shz TIV2 0.5 mL at Day 0. |
| Group 5: >=61 years | EXPERIMENTAL | Participants will receive one injection of SP Shz QIV 0.5 mL or SP Shz TIV1 0.5 mL or SP Shz TIV2 0.5 mL at Day 0. |
| Quadrivalent Influenza Vaccine | EXPERIMENTAL | Quadrivalent Influenza Vaccine (split-virion, inactivated) Northern hemisphere seasonal formulation 2018-2019 |
| Group 1: Licensed 2010-2011 TIV | ACTIVE_COMPARATOR | Participants will receive the Licensed 2010-2011 Trivalent Influenza Vaccine containing the primary B strain. |
| Group 2: Investigational TIV | EXPERIMENTAL | Participants will receive the Investigational Trivalent Influenza Vaccine containing the alternate B strain |
| Group 3: Investigational QIV | EXPERIMENTAL | Participants will receive the investigational Quadrivalent Influenza Vaccine |
| Standard-Dose Quadrivalent Influenza Vaccine | ACTIVE_COMPARATOR | QIV-SD single injection at Day 0 |
| High-Dose Quadrivalent Influenza Vaccine | EXPERIMENTAL | QIV-HD single injection at Day 0 |
| Name | Type | Description |
|---|---|---|
| Quadrivalent Influenza Vaccine | BIOLOGICAL | Pharmaceutical form: Suspension for injection Route of administration: intramuscular |
| Trivalent Influenza Vaccine 1 SP Shz TIV1 | BIOLOGICAL | Pharmaceutical form: Suspension for injection Route of administration: intramuscular |
| Trivalent Influenza Vaccine 2 SP Shz TIV2 | BIOLOGICAL | Pharmaceutical form: Suspension for injection Route of administration: intramuscular |
| Licensed 2010-2011 Trivalent Influenza Vaccine, No Preservative | BIOLOGICAL | 0.25 mL (6 to 35 months) or 0.5 mL (3 to \<9 years), Intramuscular |
| Investigational Trivalent Influenza Vaccine with alternate B strain, No Preservative | BIOLOGICAL | 0.25 mL (6 to 35 months) or 0.5 mL (3 to \<9 years), Intramuscular |
| Quadrivalent Influenza Vaccine, No Preservative | BIOLOGICAL | 0.25 mL (6 to 35 months), or 0.5 mL(3 to \<9 years), Intramuscular |
| Standard-Dose Quadrivalent Influenza Vaccine | DRUG | For the control arm, the standard-dose quadrivalent influenza vaccines Influvactetra® and Vaxigriptetra will be used. |
| High-Dose Quadrivalent Influenza Vaccine | DRUG | For the control arm, the high-dose quadrivalent influenza vaccine Efluelda®/Fluzone® High-Dose Quadrivalent will be used. |
Inclusion criteria : * Aged ≥ 6 months on the day of the first study visit/inclusion * In good health or with underlying medical condition(s) that are judged to be stable by the investigator. Medically-stable is defined as: * No new diagnosis OR * No new class of prescription drug initiated du...