Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
hexavalent reassortant rotavirus attenuated live vaccine · 2 trials · 1 indication
The seroconversion rate of IgA antibodies against vaccine-type rotavirus in serum
Incidence of adverse events/reactions
Incidence of adverse events/reactions
| Arm | Type | Description |
|---|---|---|
| Low dose | EXPERIMENTAL | The experimental vaccine will be administered in three doses, with a 28-day interval between each dose. |
| High dose | EXPERIMENTAL | The experimental vaccine will be administered in three doses, with a 28-day interval between each dose. |
| Control | ACTIVE_COMPARATOR | The controlled vaccine will be administered in three doses, with a 28-day interval between each dose. |
| Adult | EXPERIMENTAL | The experimental vaccine will be administered in three doses, with a 28-day interval between each dose. |
| Children | EXPERIMENTAL | The experimental vaccine will be administered in three doses, with a 28-day interval between each dose |
| Infants low-dose 1 | EXPERIMENTAL | They will receive three low-dose experimental vaccine in a double-blind setting, with a 28-day interval between each dose. |
| Infants low-dose 2 | PLACEBO_COMPARATOR | They will receive three doses of the placebo in a double-blind setting, with a 28-day interval between each dose |
| Infants high-dose 1 | EXPERIMENTAL | They will receive three high-dose experimental vaccine in a double-blind setting, with a 28-day interval between each dose |
| Infants high-dose 2 | PLACEBO_COMPARATOR | They will receive three doses of the placebo in a double-blind setting,with a 28-day interval between each dose |
| Name | Type | Description |
|---|---|---|
| Oral hexavalent reassortant rotavirus attenuated live vaccine | BIOLOGICAL | Oral hexavalent reassortant rotavirus attenuated live vaccine (low-dose) three doses administered orally |
| Oral pentavalent reassortant rotavirus attenuated live vaccine (controlled) | BIOLOGICAL | The controlled vaccine three doses administered orally |
| Placebo | BIOLOGICAL | Placebo of experimental vaccine for infants three doses administered orally |
Inclusion Criteria: 1. Healthy infants aged 6 to 12 weeks. 2. The legal guardian(s) is/are capable of understanding and voluntarily signing the informed consent form. 3. The legal guardian(s) is/are willing and able to comply with all follow-up visits, sample collection, vaccination, and other stud...