A PROSPECTIVE, RANDOMIZED, PARTIALLY BLIND, CONTROLLED WITH PLACEBO, MULTICENTER, PHASE III STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND IMMUNOGENICITY OF THE LIQUID VACCINE WITH INFLUENZA VIRUS, TRIVALENT, OF TYPES A AND B, LIVE, ADAPTED BY COLD (CAIV- T LIQUID) ADMINISTERED IN CONCOMITANT FORM WITH VACCINE OF LIVE POLIOVIRUS, ATTENUATED, IN HEALTHY CHILDREN.
- Conditions
- -J111 Influenza with other respiratory manifestations, virus not identifiedInfluenza with other respiratory manifestations, virus not identifiedJ111
- Registration Number
- PER-034-01
- Lead Sponsor
- ABORATORIOS WYETH S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• Those who are at least 6 months old and less than 36 months old at the time of their first vaccination
• Those who have received the complete primary vaccination scheme consisting of three doses of OPV in the first year of life
• Those who enjoy good demonstrable health by clinical history, physical examination and clinical judgment
• The one whose parent (s) / guardian (s) has provided written informed consent after the nature of the study has been explained to them
• Who, together with their parent (s) / guardian (s) are available for the duration of the study (3 months)
• The one whose parent (s) / guardian (s) can be located (s) by the study staff for post-vaccination contacts [phone, clinic or home]
• The one whose parent (s) / guardian (s) are considered as not available or difficult to contact for evaluation or for study visits during the course of the same.
• Anyone with any serious chronic illness (eg, with signs of heart or kidney failure or severe malnutrition), including progressive neurological diseases
• Whoever has Down syndrome or other genetic disorders
• Who knows or suspects having a disease of the immune system or those who receive immunosuppressive therapy, including systemic corticosteroids
• Whoever received any blood product, including immunoglobulin, in the six-month period prior to the vaccination and until the conclusion of the study
• Whoever intends to administer any other vaccine or agent under investigation from one month prior to enrollment and until the conclusion of the study
• Who lives with an immunosuppressed or immunocompromised person in the same house
• Who, at any time prior to entering this study, has received a dose of any influenza vaccine (commercial or investigational)
• Anyone with a documented history of hypersensitivity to the egg or its protein or to any other component of the assigned study vaccine
• Who has received aspirin (acetylisalicylic acid) or products that contain it in the two weeks prior to vaccination or whose use is anticipated during the study
• Anyone who suffers any medical disorder that in the opinion of the Investigator could interfere with the interpretation of the results of the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method