Test subjects are healthy.
Conditions
Interventions
Trade Name: RotaTeq
Pharmaceutical Form: Oral solution in single-dose container
Sponsors
Vaccine Research Center, University of Tampere
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All healthy six week old children who are born in Turku. Are the trial subjects under 18? yes Number of subjects for this age range: 250 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: - The subject has or is under suspect of immunological disorder or congenital/acquired state of immune deficiency (e.g. HIV, splenomagaly). - Child is treated with immunosuppressants. - Known or suspected allergy or previous serious allergic reaction caused by some ingridient of RotaTeq vaccine. - Chronic illness, which might interfere taking part to this study. - Child has reveiced blood transfusion or blood products including immunoglobulins. - Child has already had rotavirus infection. - Previous invagination. - Congenital malformation of GI tract. - Child is born before week 32 of pregnancy. - Congenital hearth defect.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: During winter 2015-16.;Main Objective: Main goal is to find out the immune response created by RotaTeq vaccine after each dose and its relation to shedding of vaccine derived viruses.;Secondary Objective: To study the rotavirus antigen levels after each dose of the vaccine.;Primary end point(s): -Shedding of RotaTeq vaccine in stools after each vaccination dose results in lower IgA levels in serum. -Shedding of RotaTeq vaccine strains is more common after the first dose than after second or third immunization. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Prolonged shedding of RotaTeq results to formation of vaccine derived double reassortants -Family members with gastroenteritis symptoms of recently vaccinated children are more often infected by vaccine originated rotaviruses.;Timepoint(s) of evaluation of this end point: During winter 2015-16. | — |
Countries
Finland
Contacts
Public ContactVaccine Research Center
University of Tampere
Outcome results
None listed