None listed
Conditions
Interventions
Two oral doses will be administered to healthy infants 6-12 weeks of age at the time of Dose 1, according to the O to 2 month schedule.
Sponsors
GLAXOSMITHKLINE BIOLOGICALS,
Eligibility
Inclusion criteria
Inclusion criteria: • The researcher (and the project doctor) should be convinced that the father, mother or legal guardian has understood the purpose of the project and its procedures and thinks that it will comply with the procedures. • Being a boy or girl and having an age between 6 to 12 weeks (42 to 90 days) of age at the time of receiving the first dose of vaccine or placebo. • The mother, father or legal guardian signed the informed consent form. • Be free of any chronic or severe disease that affects the study, at the discretion of the doctor, after the clinical examination of the child.
Exclusion criteria
Exclusion criteria: • Use of any research product (vaccine or drug) other than the vaccine of the study within 30 days preceding the first dose of the study or that is planned to do so during the duration of the study. • Child is unlikely to reside in the study area for the duration of the project. • Documentation of an episode of previous rotavirus diarrhea. • Family contacts with a disease or chronic immunosuppressive medication or a pregnant woman. • Have a chronic immunosuppressive disease, including AIDS, or take immunosuppressants for an important period of time. • History of a chronic gastrointestinal disease, including uncorrected gastrointestinal malformations. • Any serious illness that in the opinion of the investigator deserves the child to be excluded from the study. • History of allergies that could be exacerbated by some component of the vaccine or placebo. • Have received immunoglobulins or any blood product
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:La Consistencia dos meses despues de la Dosis 2 fueron alcanzados, todos los pares de lotes, las dos partes de los IC 90% para la proporcion de las GMC del anticuerpo IgA anti-rotavirus dos meses despues de la Dosis 2, estan en el limite del limite del sistema Measure:Consiste en un lote de la vacuna HRV en terminos de inmunogenicidad como la medicion de los niveles sericos del anticuerpo IgA anti-rotavirus dos meses despues de la Dosis 2. Timepoints:two month | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The immunogenicity of the HRV vaccine in terms of the serum levels of the IgA antirotavirus antibody, two months after the dose 1. Measure:Assess in a subgroup of subjects of a study center Timepoints:two month | — |
Countries
Belgium, Brazil, Canada, Finland, Germany, Mexico, Peru, Singapore, South Africa, United States, Venezuela
Contacts
Public ContactClaudio Franco Lanata
INSTITUTO DE INVESTIGACION NUTRICIONAL
Outcome results
None listed