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NCT01807780 Clinical Trial

Safety, Immunogenicity And Efficacy Of Vaccination In Military Personnel

Vaccination Failure Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01807780
Other study ID # 01/2011 UGSAN
Secondary ID
Status Completed
Phase Phase 4
First received December 13, 2012
Last updated May 2, 2017
Start date September 2012
Est. completion date September 2015

Study information
Verified date May 2017
Source University of Roma La Sapienza
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine if multiple vaccination in military personnel may be correlated with the appearance of poorly defined diseases as symptomatic multisyndrome, autoimmune or lymphoproliferative disorders. At the same time, considering possible interference between different vaccines, proteins and polysaccharides, living and inactivated, the study aims to assess the immunogenicity and efficacy also in relation to the specific Human Leucocyte Antigens (HLA) genetic structure.

Recruitment information / eligibility
Status Completed
Enrollment 262
Est. completion date September 2015
Est. primary completion date December 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- Military volunteers

- No recently immunized

Exclusion Criteria:

- Pregnancy

- Documented immunodepression

- Documented allergy or hypersensitivity to vaccines

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• biological monitoring

Locations
Country Name City State
Italy University of Roma La Sapienza Roma Italia

Sponsors (1)
Lead Sponsor Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary immunomediated disorders related to multiple vaccination three years
Secondary efficacy of multiple vaccination Three years
Secondary immunogenicity of multiple vaccination Three years
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