Shedding and immune response of rotavirus vaccine (RotaTeq)

Phase 1

• Conditions: Test subjects are healthy.; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2014-004252-60-FI
• Lead Sponsor: Vaccine Research Center, University of Tampere

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-11-26
• Last Update Posted: 9 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 250

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

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified