None listed
Conditions
Interventions
Group 1 Type of group
CAIV-T (IN) + OPV and after 35 days CAIV-T (IN) is applied again
Group name:Group 3 Type of group
CAIV-T (IN) and after 35 days CAIV-T (IN) is administered again
Sponsors
LABORATORIOS WYETH S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: • 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]
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The immunological response to OPV for each type of poliovirus is measured at the end of the study by a viral neutralization test titre of 1:10 or greater. Measure:OPV Inmunological response Timepoints:At the end of the study ; Outcome name:The immunological response of CAIV-T for each viral strain is measured at the end of the study as an increase in initial HAI by four times or greater. Measure:CAIV-T Inmunological response Timepoints:At the end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The primary interval of analysis for poliovirus types 1, 2 and 3 is one month after the single dose of OPV. Measure:Titration of serum antibody for each antigenic component of OPV Timepoints:1 month after vaccination ; Outcome name:The primary interval of analysis for influenza A / H1N1, A / H3N2 and B strains is one month after the second intranasal vaccination Measure:The ratio of titers of the initial serum antibody to each viral strain of CAIV-T Timepoints:1 month after vaccination ; Outcome name:The safety and tolerability of CAIV-T in healthy children aged between 6 and 36 months by recording adverse effects. Measure:Safety and Tolerability Timepoints:During the treatment | — |
Outcome results
None listed