Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Heat Stable Rotavirus Vaccine · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Heat Stable Rotavirus (HSRV) Vaccine | EXPERIMENTAL | 25 healthy adults who will be administered a single dose of test HSRV vaccine |
| Placebo for Heatstable Rotavirus vaccine | PLACEBO_COMPARATOR | 25 healthy adults who will be administered a single dose of placebo |
| Heat Stable Rotavirus Vaccine | EXPERIMENTAL | 25 healthy infants who will be administered 3-doses of test HSRV vaccine spaced at 4-week intervals |
| RotaTeq | ACTIVE_COMPARATOR | 25 healthy infants who will be administered 3-doses of comparator Rotateq® vaccine spaced at 4-week intervals |
| Name | Type | Description |
|---|---|---|
| Heat Stable Rotavirus (HSRV) Vaccine | BIOLOGICAL | It is a lyophilized live attenuated pentavalent (G1-G4 and P1\[8\]) heat-stable rotavirus vaccine (HSRV) comprising of all the five rotavirus strains as in licensed RotaTeq® vaccine for protection against rotavirus infection |
| Placebo for Heatstable Rotavirus vaccine | BIOLOGICAL | It is a lyophilized formulation comprising of all the inactive ingredients as in heat stable rotavirus vaccine without any rotavirus |
| RotaTeq® | BIOLOGICAL | It is a pentavalent human-bovine (WC3) reassortant live-attenuated, oral vaccine developed by Merck Research Co., West Point, Pennsylvania, USA. This vaccine contains five live reassortant rotaviruses. Four reassortant rotaviruses express the VP7 protein (G1, G2, G3, or G4) from the human rotavirus parent strain and the attachment protein (P7\[5\]) from bovine rotavirus parent strain WC3. The fifth reassortant virus expresses the attachment protein (P1A\[8\]) from the human rotavirus parent strain and the outer capsid protein G6 from the bovine rotavirus parent strain. |
Inclusion Criteria: Healthy Adults: 1. Healthy adult subjects of either sex, between 18 to 45 years of age; 2. No apparent signs or symptoms of ill health; 3. Subjects properly informed about the study and having signed the informed consent form (ICF). In case of subjects' inability to read or wri...