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...
It is an investigational oral vaccine designed to prevent rotavirus gastroenteritis. It is a live, attenuated vaccine built from six reassortant rotavirus strains and is given by mouth. Sinovac Biotech, Ltd is developing it, and it is currently in Phase 2 clinical development.
It is being developed for the prevention of rotavirus gastroenteritis. Rotavirus gastroenteritis is the condition studied in its clinical program. The vaccine is given orally and is intended for healthy volunteers, with trials enrolling infants from 6 weeks of age.
Sinovac Biotech, Ltd is developing the hexavalent reassortant rotavirus attenuated live vaccine. The company trades under the ticker SVA. The vaccine is an oral live attenuated product manufactured using Vero cells, as reflected in the trial titles for its Phase 1 and Phase 2 studies.
The vaccine is in Phase 2 clinical development. A Phase 2 trial is currently recruiting, and a Phase 1 trial has been completed. Across the two trials, approximately 500 participants have been or are being enrolled, and the studies are randomized, double-blind, and placebo-controlled.
Two trials are registered. NCT06967272 is a recruiting Phase 2 trial with planned enrollment of 400 participants. NCT06950645 is a completed Phase 1 trial with 100 participants. Both were conducted in China, enrolled healthy volunteers from 6 weeks of age, and studied rotavirus gastroenteritis.
Yes, they are the same product. The oral hexavalent reassortant rotavirus attenuated live vaccine is the full name used in the trial titles, and it refers to the same Sinovac Biotech candidate given by mouth. The word oral describes the route of administration rather than a separate vaccine.