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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00363545 | To Assess Immunogenicity, Reactogenicity & Safety of 2 Formulations of GSK's HRV Vaccine as 2-dose Vaccination (Infants) | PHASE3 | COMPLETED | 1,274 | — | — | Sep 1, 2006 | Apr 12, 2007 | Jun 8, 2018 | 3 | Panama |
| NCT00383903 | Evaluate Safety & Immunogenicity of 2 or 3 Doses of GSK HRV Vaccine in Healthy Infants in South Africa | PHASE2 | COMPLETED | 472 | — | — | Sep 1, 2003 | Sep 1, 2004 | Sep 15, 2016 | 6 | South Africa |
| NCT00385320 | Evaluate Protective Efficacy of Diff Strengths of Human Rotavirus Vaccine After Admn of 2 Doses to Infants Aged 2 Months | PHASE2 | COMPLETED | 2,640 | — | — | May 31, 2001 | Apr 30, 2003 | Dec 27, 2019 | - | — |
A seroconverted subject was defined as a vaccinated subject who had an anti-rotavirus IgA antibody concentration equal to or above (≥) 20 units per milliliter (U/mL) and who was initially (i.e. prior to the first dose of Rotarix™ vaccine) negative for rotavirus.
| Arm | Type | Description |
|---|---|---|
| Liquid Rotarix Group | EXPERIMENTAL | Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the liquid formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule. |
| Lyophilized Rotarix Group | EXPERIMENTAL | Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the lyophilized formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule. |
| Name | Type | Description |
|---|---|---|
| Lyophilized formulation of HRV vaccine | BIOLOGICAL | Lyophilized formulation of HRV vaccine |
| Liquid formulation of HRV vaccine | BIOLOGICAL | Liquid formulation of HRV vaccine |
| HRV vaccine | BIOLOGICAL | Two or three oral doses |
Inclusion Criteria: * Healthy male or female infant between, and including, 6 and 12 weeks of age born after a gestation period of 36 to 42 weeks. * Written informed consent obtained from the parent or guardian of the subject. Exclusion Criteria: * se of any investigational or non-registered prod...