Status:
ACTIVE_NOT_RECRUITING
Immune Response To Intranasal Influenza Vaccination
Lead Sponsor:
University of Bergen
Collaborating Sponsors:
Haukeland University Hospital
Conditions:
Tonsillitis, Hypertrophy
Eligibility:
All Genders
2-59 years
Phase:
NA
Brief Summary
This research during the last decade has focused on the kinetics of the systemic and local immune response to parenteral influenza vaccine in humans. The investigators have shown that normally high nu...
Detailed Description
The clinical trial will be an open study. All subjects eligible for tonsillectomy at Haukeland University Hospital within the specified age range (children: 2 to less than 18 years old and adults \>18...
Eligibility Criteria
Inclusion
- Healthy children (age range ≥2 and \<18 years old) or adults (\>18-59 years old) as concluded from the medical history, physical examination, and clinical judgment) scheduled for tonsillectomy ;
- Signed informed consent from the subject or both parents/ both guardians and from subjects aged 12 years and older;
- Subjects or guardians able to understand and comply with the study protocol and complete the Adverse Event Form:
- Subjects able to attend the scheduled visits.
Exclusion
- Persons with a history of anaphylaxis or serious reactions to any vaccine;
- Person with known hypersensitivity to any of the vaccine components (e.g. gelatin, gentamicin, eggs or egg proteins (e.g. ovalbumin);
- Persons who are pregnant
- Persons who have had a temperature \>38oC during the previous 72 hours;
- Persons who have had an acute respiratory infection during the last 7 days;
- Persons who are clinically immunodeficient due to conditions or immunosuppressive therapy such as: acute and chronic leukaemias; lymphoma; symptomatic HIV infection; cellular immune deficiencies; and high-dose corticosteroids;
- Persons with severely immunocompromised family members;
- Persons with severe asthma or active wheezing.
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01866540
Start Date
October 1 2012
End Date
December 31 2030
Last Update
December 6 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Haukeland University Hospital
Bergen, Norway, N5021