STUDY PHASE III, RANDOMIZED, DOUBLE-BLIND AND CONTROLLED BY PLACEBO, TO EVALUATE THE CLINICAL CONSISTENCY OF THREE LOTS OF VACCINE PRODUCTION HRV OF GSK BIOLOGICALS IN IMMUNOGENICITY AND SECURITY TERMS, WHEN ADMISSION TO HEALTHY INFANTS AT 2 AND 4 MONTHS OF AGE .
- Registration Number
- PER-046-03
- Lead Sponsor
- GLAXOSMITHKLINE BIOLOGICALS,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• 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.
• 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method