Table 2.
Similarities Across Trial Protocols and Definitions
| Category | Study Protocol and Definitions |
|---|---|
| Inclusion criteria | Male and female infants Healthy subjects free of all obvious health problems (established by medical history and physical exam) |
| Exclusion and/or elimination criteria | Use of investigational or nonregistered product (drug or vaccine) within 30 days prior to study vaccine dose Planned administration of a vaccine not foreseen by the study protocol within 14 days of study vaccine dose Chronic administration (defined as > 14 days) of immunosuppressants anytime since birth Any confirmed or suspected immune-suppressive or deficient condition based on medical history and exam Significant history of chronic gastrointestinal disease History of allergic reaction to any vaccine component Acute disease, defined as the presence of a moderate or severe illness with or without fever, at the time of enrollment (warrants deferral of vaccination) Administration of immunoglobulins and/or blood product since birth or planned administration during the study |
| Vaccine | GSK RIX 4414 HRV vaccine Vaccinated arm with viral suspension of ≥ 106.0 CCID50a Doses administered 1–2 months apart |
| Medical exam and history | Medical exam and history obtained at enrollment Concomitant medications/vaccinations, history of medication/vaccination recorded at study visits Anthropometric measurements obtained |
| Gastrointestinal illness | Defined as diarrhea with or without vomiting Diarrhea defined as ≥ 3 looser than normal stools in a 24-hour period Severity measured on Vesikari scale Symptoms, duration, medical treatment sought recorded on a diary card provided by the study |
| Stool samples | Collected as soon as possible and no later than 7 days of severe gastrointestinal illness Tested via ELISA, including rotavirus strain determination |
| Serology | Collected 1–3 months after final vaccine dose Samples tested via ELISA, assay cutoff of antirotavirus IgA ≥ 20 U/mL |
Abbreviations: CCID50, 50% cell culture infectious dose; ELISA, enzyme-linked immunosorbent assay; GSK, GlaxoSmithKline; IgA, immunoglobulin A.
aHighest viral suspensions of 104.7 and 105.8 median CCID50 in trial 444 563/004 and 444 563/006, respectively.