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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05212623 | A Clinical Trial of an Quadrivalent Inactivated Influenza Vaccine in Healthy Children Aged 6 to 35 Months | PHASE1 | COMPLETED | 120 | — | — | Oct 26, 2021 | Jun 16, 2022 | Oct 28, 2022 | 1 | China |
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | Subjects received 2 doses of 0.25 mL of quadrivalent influenza vaccine, 4 weeks apart. Each 0.25-ml dose contained 7.5 μg of hemagglutinin per strain (Four types of virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata). |
| Group B | EXPERIMENTAL | Subjects received 2 doses of 0.5 mL of quadrivalent influenza vaccine, 4 weeks apart. Each 0.5-ml dose contained 15 μg of hemagglutinin per strain.(Four types of virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata). |
| Group C | ACTIVE_COMPARATOR | Subjects received 2 doses of 0.25 mL of influenza vaccine, 4 weeks apart. Each 0.25-ml dose contained 7.5 μg of hemagglutinin per strain (3 type of virus strains, including BY). |
| Group D | ACTIVE_COMPARATOR | Subjects received 2 doses of 0.25 mL of influenza vaccine, 4 weeks apart. Each 0.25-ml dose contained 7.5 μg of hemagglutinin per strain (3 types of virus strains, including BV). |
| Name | Type | Description |
|---|---|---|
| quadrivalent influenza split vaccine | BIOLOGICAL | This vaccine is produced by Changchun Sponsor Institute of Biological Products Co., Ltd. Subjects will receive two doses of quadrivalent influenza vaccine administered 4 weeks apart by intramuscular injection |
| Influenza virus split vaccine | BIOLOGICAL | This vaccine is produced by Changchun Sponsor Institute of Biological Products Co., Ltd. Subjects will receive two doses of quadrivalent influenza vaccine administered 4 weeks apart by intramuscular injection |
Inclusion Criteria: * Healthy infants and young children aged 6-35 months, provide vaccination certificate and birth medical certificate. * The subject or legal guardian can provide with informed consent and sign the informed consent form. * The subjects or legal guardians are able to and willing t...